Data / Medical devices / United States / Covidien
Covidien: FDA-registered device maker in North Haven, CT, United States, 251 510(k) clearances and 1 PMA approval
Covidien is registered with the FDA (registration 1219930) in North Haven, CT, United States. It lists 74 device types. The FDA files 251 510(k) clearances and 1 PMA approval under its listings, the newest dated July 1, 2026. 74 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1219930
- Address
- 60 Middletown Ave, North Haven, CT, United States, 06473
- Owner or operator
- Covidien llc (1282497)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- June 29, 1992
- Registered through
- 2026
- Brand names listed
- 4 Calibration Insert, 8 TRUCLEAR Sheath, 9 TRUCLEAR Obturator, ACUCLIP, ANTI-FOG, AS Meniscal, ATLAS, AUTO SUTURE ENDO CATCH SPECIMAN BAG and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 251.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 1, 2026 | K253527 | Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) | GAG | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| May 28, 2026 | K253530 | Trexon Monofilament Synthetic Absorbable Suture | GAM | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| April 10, 2026 | K253657 | Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads | GDW | Substantially Equivalent | Covidien (Part of Medtronic) | accessdata.fda.gov |
| December 3, 2025 | K250725 | Hugo RAS System | SCV | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| November 1, 2024 | K240881 | Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL) | GAG | Substantially Equivalent | Covidien (Part of Medtronic) | accessdata.fda.gov |
| October 27, 2023 | K231934 | GIA Stapler with Tri-Staple Technology | GAG | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 8, 2023 | K231240 | MaxTack Motorized Fixation Device | OCW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| February 22, 2023 | K221629 | Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters) | GAG | Substantially Equivalent | Covidien | accessdata.fda.gov |
| November 29, 2022 | K222641 | Signia Small Diameter Reloads Including Regular (Round) Tip Version | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| June 27, 2022 | K213818 | VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| April 29, 2022 | K221006 | GIA Stapler with Tri-Staple Technology | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| December 7, 2020 | K202701 | GIA Stapler with Tri-Staple Technology | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 28, 2020 | K202864 | Tri-Staple 2.0 Reloads | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| August 26, 2020 | K201805 | VersaOne Reusable Positioning Trocar System | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| July 17, 2020 | K201672 | Signia Stapler (with new software) | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 13, 2020 | K192720 | GIA Stapler with Tri-Staple Technology | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 4, 2019 | K191070 | Signia Small Diameter Reloads | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 14, 2019 | K182475 | Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters) | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| August 29, 2018 | K180496 | TruClear Elite Hysteroscope | HIH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| June 21, 2018 | K181085 | LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 28, 2018 | K173489 | GYN-Pump PH304 | HIG | Substantially Equivalent | W.O.M. World of Medicine GmbH | accessdata.fda.gov |
| March 26, 2018 | K180149 | Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide | LFL | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| March 2, 2018 | K173281 | LigaSure Exact Dissector, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| February 20, 2018 | K173270 | Tri-Staple 2.0 Reinforced Reload | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| February 16, 2018 | K172361 | EEA Circular Stapler with Tri-Staple Technology | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| December 7, 2017 | K171336 | Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath | FAJ | Substantially Equivalent | Henke-Sass, Wolf GmbH | accessdata.fda.gov |
| April 21, 2017 | K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 8, 2017 | K163654 | VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar | GCJ | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| March 2, 2017 | K170348 | Signia Four-Bay Smart Charger (to be used with Signia Stapler) | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| December 5, 2016 | K163098 | Tri-Staple 2.0 Intelligent Cartridge | GDW | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| November 30, 2016 | K163102 | ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| November 22, 2016 | K161763 | Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device | HIH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 14, 2016 | K162941 | Ligasure Blunt Tip, Sealer/Divider, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 18, 2016 | K162584 | VersaOne Bladeless Trocar | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 16, 2016 | K161804 | LigaSure Retractable L-Hook Laparoscopic Sealer/Divider | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 15, 2016 | K162047 | LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 7, 2016 | K161347 | Signia sterilization tray | KCT | Substantially Equivalent | Covidien | accessdata.fda.gov |
| May 4, 2016 | K160654 | GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) | KNT | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| April 26, 2016 | K160176 | Signia Stapler | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 1, 2016 | K160230 | VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 22, 2016 | K152149 | VersaOne Bladed Trocar 5mm | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 26, 2015 | K151182 | LiquiBand Exceed | MPN | Substantially Equivalent | Advanced Medical Solutions (Plymouth), Ltd. | accessdata.fda.gov |
| September 14, 2015 | K143644 | Premium Surgiclip¿; Endo Clip¿; AcuClip¿ | FZP | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 2, 2015 | K152143 | TRUCLEAR Operative Hysteroscope 5C and Sheath 5C | HIH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 17, 2015 | K151659 | ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks | GDW | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| July 2, 2015 | K151548 | VersaOne Bladed Trocar, VersaOne Bladeless Trocar | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| June 18, 2015 | K151356 | Spacemaker Pro Access and Dissector System | GCJ | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| May 29, 2015 | K151163 | Signia Loading Unit, Tri-Staple 2.0 Cartridge | GDW | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| March 12, 2015 | K143598 | Lapro-Clip Auto Suture Reusable Long Clip Applier | FZP | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| February 25, 2015 | K143088 | GastriSail Gastric Positioning System | KNT | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 27, 2015 | K142929 | Ligasure Blunt Tip Sealer/Divider | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| December 9, 2014 | K142547 | Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| November 26, 2014 | K143091 | Surgisleeve Wound Protector | GCJ | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| October 30, 2014 | K142869 | Premium Surgiclip III | FZP | Substantially Equivalent | Covidien | accessdata.fda.gov |
| August 7, 2014 | K141371 | SONICISION CORDLESS ULTRASONIC DISSECTOR | LFL | Substantially Equivalent | Covidien, Formerly Valleylab, A Division of Tyco H | accessdata.fda.gov |
| April 9, 2014 | K140609 | RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 12, 2014 | K140064 | SURGISLEEVE WOUND PROTECTOR | KKX | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 22, 2014 | K133938 | ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 8, 2014 | K133762 | ENDO GIA(TM) EXTRA LONG ADAPTER | GDW | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| December 20, 2013 | K133338 | LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX) | GEI | Substantially Equivalent | Covidien, Formerly Valleylab, A Division of Tyco H | accessdata.fda.gov |
| December 13, 2013 | K132015 | TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS | HIH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 23, 2013 | K132493 | ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY | GDW | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| September 26, 2013 | K132777 | NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER | LIT | Substantially Equivalent | Ev3, Inc. | accessdata.fda.gov |
| July 1, 2013 | K131705 | ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY | GDW | Substantially Equivalent | Covidien, Formerly US Surgical A Divison of Tyco H | accessdata.fda.gov |
| May 30, 2013 | K130532 | IDRIVE ULTRA STERILIZATION TRAY | KCT | Substantially Equivalent | Covidien, Formerly US Surgical A Divison of Tyco H | accessdata.fda.gov |
| April 18, 2013 | K130717 | ENDO GIA RELOAD | GDW | Substantially Equivalent | Covidien, Formerly US Surgical A Divison of Tyco H | accessdata.fda.gov |
| April 5, 2013 | K130782 | ACCUMESH DEPLOYMENT SYSTEM | ORQ | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| April 5, 2013 | K130744 | LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 14, 2013 | K130435 | VERSAPORT V2 BLADELESS OPTICAL TROCAR | GCJ | Substantially Equivalent | Covidien, Formerly US Surgical A Divison of Tyco H | accessdata.fda.gov |
| March 11, 2013 | K121904 | GYNECOLOGY STERILIZATION TRAY | KCT | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Division | accessdata.fda.gov |
| February 5, 2013 | K122781 | RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD | GDW | Substantially Equivalent | Covidien, Formerly US Surgical A Divison of Tyco H | accessdata.fda.gov |
| January 30, 2013 | K123444 | LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER | GEI | Substantially Equivalent | Covidien, Formerly Valleylab, A Division of Tyco H | accessdata.fda.gov |
| December 18, 2012 | K123318 | IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER | GDW | Substantially Equivalent | Covidien, Formerly US Surgical A Divison of Tyco H | accessdata.fda.gov |
| October 26, 2012 | K122446 | LIQUIDBAND FLOW CONTROL | MPN | Substantially Equivalent | Advanced Medical Solutions (Plymouth), Ltd. | accessdata.fda.gov |
| October 23, 2012 | K123109 | ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 9, 2012 | K122531 | SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T | JOH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| July 25, 2012 | K121510 | IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER | GDW | Substantially Equivalent | Covidien, Formerly US Surgical A Divison of Tyco H | accessdata.fda.gov |
| May 3, 2012 | K121194 | ENDO CLIP III 5MM CLIP APPLIER | FZP | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 27, 2012 | K120061 | WOUND PROTECTOR | GCJ | Substantially Equivalent | Covidien, Formerly US Surgical A Divison of Tyco H | accessdata.fda.gov |
| November 22, 2011 | K112134 | TRUCLEAR OPERATIVE HYSTEROSCOPE | HIH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 25, 2011 | K111825 | ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS | GDW | Substantially Equivalent | Covidien, Formerly US Surgical A Divison of Tyco H | accessdata.fda.gov |
| September 1, 2011 | K112349 | VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR | GCJ | Substantially Equivalent | Covidien, Formerly US Surgical A Divison of Tyco H | accessdata.fda.gov |
| June 3, 2011 | K111442 | V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)... | GAM | Substantially Equivalent | Covidien, Formerly US Surgical A Divison of Tyco H | accessdata.fda.gov |
| March 25, 2011 | K103389 | TRUCLEAR INCISOR PLUS BLADE 2.9 | HIH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 24, 2011 | K103253 | SILS PORT | GCJ | Substantially Equivalent | Coviden (Formerly Registered AS US Surgical, A Div | accessdata.fda.gov |
| February 24, 2011 | K101797 | SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T | LFL | Substantially Equivalent | Covidien, Formerly Valleylab, A Division of Tyco | accessdata.fda.gov |
| November 22, 2010 | K103263 | ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY | GDW | Substantially Equivalent | Covidien, Formerly US Surgical A Divison of Tyco H | accessdata.fda.gov |
| November 10, 2010 | K103052 | V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE | GAT | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| October 13, 2010 | K102325 | IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD) | GDW | Substantially Equivalent | Covidien, LLC, Formerly Registered AS Tyco Healthca | accessdata.fda.gov |
| September 15, 2010 | K102291 | COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| June 14, 2010 | K101444 | AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY | GDW | Substantially Equivalent | Surgical Devices, A Global Business Unit Tyco | accessdata.fda.gov |
| May 10, 2010 | K100257 | VLOC9ABSORBABLE WOUND CLOSURE DEVICE | GAM | Substantially Equivalent | Surgical Devices, A Division of Tyco Healthcare | accessdata.fda.gov |
| April 26, 2010 | K100548 | VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP | GCJ | Substantially Equivalent | Covidien Lp, Formerly Registered AS Tyco Healthcar | accessdata.fda.gov |
| February 17, 2010 | K100242 | AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER | FZP | Substantially Equivalent | Surgical Devices, A Division of Tyco Healthcare | accessdata.fda.gov |
| December 3, 2009 | K093372 | SILS PORT MODEL SILSPT15 | GCJ | Substantially Equivalent | Covidien Lp, Formerly Registered AS Tyco Healthcar | accessdata.fda.gov |
| November 12, 2009 | K093410 | AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY | GDW | Substantially Equivalent | Surgical Devices, A Divsion of Tyco Healthcare | accessdata.fda.gov |
| November 12, 2009 | K093408 | V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE | GAM | Substantially Equivalent | Surgical Devices, A Division of Tyco Healthcare | accessdata.fda.gov |
| November 12, 2009 | K093402 | AUTOSUTURE EEA ORVIL | GDW | Substantially Equivalent | Surgical Devices, A Global Business Unit Tyco | accessdata.fda.gov |
| September 11, 2009 | K091223 | VALLEYLAB SUCTION COAGULATOR, MODEL E3305 | GEI | Substantially Equivalent | Covidien LP | accessdata.fda.gov |
| September 1, 2009 | K091869 | SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS | GCJ | Substantially Equivalent | Covidien Lp, Formerly Registered AS United States | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 22, 2002 | P010002 | INDERMIL(TM) TISSUE ADHESIVE | MPN | 4 | November 12, 2003 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 24, 2026 | 99390 | Class II | Ongoing | V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VLOCM0013 V-LOC* 90 4-0 CLR 30CM P12X12 VLOCM0013 VLOCM | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery. | accessdata.fda.gov |
| April 15, 2026 | 98871 | Class II | Ongoing | Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071 | The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure. | accessdata.fda.gov |
| September 25, 2025 | 97792 | Class II | Ongoing | Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT | A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion. | accessdata.fda.gov |
| April 15, 2024 | 94484 | Class II | Ongoing | Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT | Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery | accessdata.fda.gov |
| February 28, 2024 | 94131 | Class II | Ongoing | Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB | The potential for trocar seal disengagement when using mesh products incorrectly with the device. | accessdata.fda.gov |
| February 14, 2024 | 94128 | Class II | Ongoing | Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT | Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling Sy | accessdata.fda.gov |
| January 25, 2024 | 94351 | Class II | Ongoing | Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft tissue approximation and/or ligation. | One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence, hemorrhage, blood loss, bleeding, tissue breakdown, peritonitis, unspecified infection, vision loss (when used in ophthalmic applica | accessdata.fda.gov |
| November 16, 2023 | 93722 | Class II | Ongoing | AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures Model ABSTACK30 | Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility | accessdata.fda.gov |
| March 1, 2023 | 91873 | Class II | Ongoing | Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010 | Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk. | accessdata.fda.gov |
| January 25, 2023 | 91650 | Class II | Ongoing | Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT | Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may be associated to a delay to treatment, unspecified infection, hemorrhage/blood loss/bleeding, failure to anastomose, peritonitis, sep | accessdata.fda.gov |
| January 11, 2023 | 91567 | Class II | Ongoing | Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement of tissues during surgical repair Model Number: PCO2H3 | Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions, erosion/migration, pain, fistula, hernia (recurrence), and failure of implant | accessdata.fda.gov |
| December 2, 2022 | 91324 | Class II | Ongoing | Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM C12 (3) 88861749-24 DERMALON* 5-0 BLU 45CM P13 (4) 88861756-11 DERMALON* 6-0 BLU 45CM C13 (5) 88861757- | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact | accessdata.fda.gov |
| September 28, 2022 | 90892 | Class II | Ongoing | Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLOCA308L. Automated suturing device. | Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in the patient, foreign body reaction, allergic reaction, tissue injury and unintended radiation exposure from additional imaging for both intra-op and postoperative | accessdata.fda.gov |
| May 13, 2022 | 90362 | Class II | Ongoing | EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535. | The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage and if disengaged, could allow the device to transect tissue without forming staples. | accessdata.fda.gov |
| December 22, 2021 | 89283 | Class II | Ongoing | SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT) | Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monitor detection of a false sensor cable disconnect and reconnect may cause the monitor to discontinue monitoring and transition into the calibration screen without an audible alarm. | accessdata.fda.gov |
| May 28, 2021 | 88250 | Class II | Ongoing | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019 | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). | accessdata.fda.gov |
| April 29, 2021 | 87925 | Class II | Ongoing | Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors | The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization. | accessdata.fda.gov |
| March 4, 2021 | 87475 | Class II | Terminated | Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT | Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, the stapler may cut tissue but no staples will deploy from the empty reload, potentially resulting in a failed anastomosis | accessdata.fda.gov |
| August 12, 2020 | 86214 | Class II | Ongoing | Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery | The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation. | accessdata.fda.gov |
| January 28, 2020 | 84819 | Class II | Ongoing | McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-000 (Individual Unit); X3-003-000 (Carton of 10 Units) - Product Usage: is a tool u | Blades do not fit the McGRATH MAC video laryngoscope handle or were tight fitting on the handles which may result in a change in optical performance as displayed on the video screen | accessdata.fda.gov |
| December 18, 2019 | 84769 | Class II | Terminated | Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tiss | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | accessdata.fda.gov |
| May 17, 2019 | 82950 | Class II | Ongoing | EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis. | accessdata.fda.gov |
| November 15, 2018 | 81595 | Class II | Ongoing | Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or comp | The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient. | accessdata.fda.gov |
| October 5, 2018 | 81417 | Class II | Terminated | Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder codes are circular in shape, made from a three-dimensional monofilament polyester fabric with a two-dim | The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal hernia repair using the modified Sugarbaker repair technique. In these reports, product failure led to hernia recurrence requiring additional surgical treatment. Symptoms of hernia recurrence may include discomfort, | accessdata.fda.gov |
| July 26, 2018 | 80804 | Class II | Ongoing | Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: UDI-Device Identifier (GTIN/UPN): 10884521130319 | Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems | accessdata.fda.gov |
| June 15, 2018 | 80542 | Class II | Terminated | Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955 | Potential proplylene glycol contamination | accessdata.fda.gov |
| May 22, 2018 | 80423 | Class II | Ongoing | Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGIA45AMT | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. | accessdata.fda.gov |
| April 26, 2018 | 79974 | Class II | Terminated | Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm ( Item Code 030450) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. | accessdata.fda.gov |
| April 9, 2018 | 79905 | Class II | Terminated | EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 20884521047515 Product Usage: The EEA Hemorrhoid and prolapse stapler se | There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak. | accessdata.fda.gov |
| March 15, 2018 | 79735 | Class II | Terminated | LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is | Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices. | accessdata.fda.gov |
| December 13, 2017 | 79483 | Class II | Terminated | Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open | Product reportedly shutting down during use. | accessdata.fda.gov |
| November 21, 2017 | 79371 | Class II | Terminated | Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861 | Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation. | accessdata.fda.gov |
| October 12, 2017 | 79296 | Class II | Terminated | Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium cotton are single use cotton disposable that must be used with the Situate delivery system. The disposable have an attached RF Tag, w | This voluntary recall is being conducted due to the potential for failure to detect the affected Situate" gauze - RF and Xray detectable products by the Situate" detection console due to a manufacturing error. | accessdata.fda.gov |
| September 21, 2017 | 79154 | Class II | Terminated | GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radia | Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used. | accessdata.fda.gov |
| September 15, 2017 | 79166 | Class II | Terminated | Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection | The device cartridge disengaged during use due to manufacturing error. | accessdata.fda.gov |
| September 13, 2017 | 79169 | Class II | Terminated | Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. | Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time. | accessdata.fda.gov |
| August 7, 2017 | 79075 | Class II | Ongoing | Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1 | The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient. | accessdata.fda.gov |
| May 9, 2017 | 77300 | Class II | Terminated | Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in endoscopic surgery for swabbing small amounts of fluid or for blunt dissection of soft tissue(s) and structures, or | Cotton tip of the device may disengage due to insufficient adhesive | accessdata.fda.gov |
| May 3, 2017 | 77144 | Class II | Terminated | Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VIO PRECUT 122J; Item Number: L15; POLSORB 1 | Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material. | accessdata.fda.gov |
| March 3, 2017 | 76606 | Class II | Terminated | Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption | Product sterility is compromised due to breach of sterile barrier | accessdata.fda.gov |
| February 8, 2017 | 76497 | Class II | Terminated | BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01 | Handle may break during use. | accessdata.fda.gov |
| January 26, 2017 | 76384 | Class II | Terminated | Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk; Material # E2750NSB Product Usage: For use in 5mm cannulas or larger cannulas with 5mm adapters during laparoscopic and thorascopic | Customer reports of the device handset continuing to operate after release of the activation button. | accessdata.fda.gov |
| January 23, 2017 | 76327 | Class II | Terminated | Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contaminatio | Sterility compromised due to breach in sterile barrier | accessdata.fda.gov |
| December 16, 2016 | 76062 | Class II | Terminated | Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor Forehead SpO2Sensor, model RS10, is indicated for use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are requ | Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex. | accessdata.fda.gov |
| October 14, 2016 | 75481 | Class II | Terminated | Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099 | Sterility of the outer surface of the container compromised due to packaging defect. | accessdata.fda.gov |
| October 4, 2016 | 75301 | Class II | Terminated | Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens | Product sterility is compromised due to breach of the sterile barrier | accessdata.fda.gov |
| September 29, 2016 | 75302 | Class II | Terminated | Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles | Added Instructions for Use: After application, inspect the Light Glove for barrier integrity | accessdata.fda.gov |
| July 8, 2016 | 74602 | Class II | Terminated | Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Item Code: E253028 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the del | Potential for compromise of the package resulting in a breach of the sterile barrier | accessdata.fda.gov |
| April 15, 2016 | 73882 | Class II | Terminated | Given Imaging Bravo pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0312 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurem | Potential of an allergic reaction in a patient with nickel sensitivity. | accessdata.fda.gov |
| April 1, 2016 | 73669 | Class II | Terminated | Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) Intended to provide enteral nutrition to a patient for hospital and acute care settings. | Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm | accessdata.fda.gov |
| March 3, 2016 | 73427 | Class II | Terminated | Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, | Compromised sterility due to breach of barrier | accessdata.fda.gov |
| January 22, 2016 | 73121 | Class II | Terminated | Covidien Dover CATCH KIT SOAP Item Code: 5205 Castile soap towelettes are used to clean the genital area for male and female patients | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | accessdata.fda.gov |
| January 21, 2016 | 73115 | Class II | Terminated | Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x 36" (91 cm), Sterile; Catalog Number: 461438. Intended for pediatric feeding. | 8FR 16 PVC tubes were packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were packaged in an 8FR 20 Polyurethane packs | accessdata.fda.gov |
| December 2, 2015 | 72749 | Class II | Terminated | Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdom | Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use | accessdata.fda.gov |
| October 14, 2015 | 72416 | Class II | Terminated | Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and inf | Incorrectly packaged with a 90 degree bend at the distal tip | accessdata.fda.gov |
| August 19, 2015 | 71963 | Class II | Terminated | MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:22550PC | Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy and patient and/or clinician burns | accessdata.fda.gov |
| August 6, 2015 | 71893 | Class II | Terminated | Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devic | Sterility may be compromised | accessdata.fda.gov |
| July 31, 2015 | 71784 | Class II | Terminated | Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling | Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations | accessdata.fda.gov |
| April 23, 2015 | 70985 | Class II | Terminated | Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. | Catheters may not meet antimicrobial specification | accessdata.fda.gov |
| April 16, 2015 | 71113 | Class II | Terminated | Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, single-use cover for compatible surgical light handles. Catalog/Number/Description 31140208 3611 LIGHT GLOVE 31140216 3613 LIGHT GLOVE 31140257 361 | Devon Light Gloves contain splits or holes compromising the sterility | accessdata.fda.gov |
| May 6, 2013 | 65093 | Class II | Terminated | Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code: ONB5LGF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endo | Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity | accessdata.fda.gov |
| February 11, 2013 | 64420 | Class II | Terminated | Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis. | Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical intervention | accessdata.fda.gov |
| August 21, 2012 | 63015 | Class II | Terminated | Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code: DUET4535. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have appl | Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications | accessdata.fda.gov |
| May 9, 2012 | 61942 | Class II | Terminated | Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis | Potential for the sterility barrier to be compromised. | accessdata.fda.gov |
| February 16, 2012 | 61243 | Not yet classified | Terminated | Covidien Duet TRS Articulating 60- 3.5MM, Single Use Loading Unit Ref: DUET6035A The ENDO GIA Universal Staplers with DUET TR S Loading Units have applications in abdominal, gynecologic and pediatric surgery for resectio | Missing component results in the stapler not firing. | accessdata.fda.gov |
| January 12, 2012 | 60901 | Not yet classified | Terminated | DUET TRS 45 3.5MM STRAIGHT SULU Product Code: DUET4535 Product Usage: The ENDO GIA Universal Staplers with DUET TRS Loading Units have applications in abdominal, gynecologic and pediatric surgery for resection, transecti | Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death | accessdata.fda.gov |
| August 15, 2011 | 59798 | Not yet classified | Terminated | DUET TRS 45 3.5mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET4535 The ENDO GIA Universal Staplers with DUET TRS Loading Unit have applications in abdominal, | Sterility of the device is compromised due to a breach in the sterile packaging | accessdata.fda.gov |
| June 3, 2011 | 59104 | Not yet classified | Terminated | Syneture Sofsilk 0 18" BLACK GS-21 DT non-absorbable braided nylon sutures CS10M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsur | Potential for the sterile barrier to be breached compromising the sterility of the product | accessdata.fda.gov |
| December 15, 2010 | 57576 | Not yet classified | Terminated | AutoSuture SURGIPRO Polyproylene Mesh Clear 3" x 5" Sterile REF SPM 35 Surgipro Flat Sheet mesh is a non-absorbable, polypropylene surgical mesh exhibiting high burst strength and tensile strength. Surgipro comes in mult | Sterility compromised due to breach in sterile barrier | accessdata.fda.gov |
| February 8, 2010 | 54537 | Not yet classified | Terminated | Auto Suture ProTack Fixation 5 mm Product Catalogue # 174006. Has application in endoscopic surgery procedures. | Fixation device may fail to fire and staple. | accessdata.fda.gov |
| September 23, 2009 | 53694 | Not yet classified | Terminated | SurgASSIST System Storage Cart, product code CART; SurgASSIST Service Manual, product code SRVM; SurgASSIST System Starter Kit, product code Surg200; SurgASSIST System with Integrated Controls, product code Surg300; Oper | Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient. | accessdata.fda.gov |
| May 22, 2006 | 35491 | Not yet classified | Terminated | Auto Suture-ChemoSite Low Profile -implantable low profile Venous Access System with printed polyurethane catheter and 9 French Introducer Kit Catalog Number: 120021 | The 9F device may contain a 10 F sheath instead of the 9F | accessdata.fda.gov |
| June 30, 2005 | 32569 | Not yet classified | Terminated | ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with printed Polyurethane Catheter and 7 French Introducer Kit Catalog Number: 120011 | The peel away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use | accessdata.fda.gov |
| May 5, 2004 | 28998 | Not yet classified | Terminated | Auto Suture TA 30 Reloadable Staplers, Single Patient Use Ref TA30V3S, V3 (2.5mm) DST Series | Stapler may clamp without the staples being fired into the tissue | accessdata.fda.gov |
Compare with other makers
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Updated August 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.