Data / Medical devices / United States / Ethicon, Inc.
Ethicon, Inc.: FDA-registered device maker in Somerville, NJ, United States, 49 510(k) clearances and 3 PMA approvals
Ethicon, Inc. is registered with the FDA (registration 2210968) in Somerville, NJ, United States. It lists 30 device types. The FDA files 49 510(k) clearances and 3 PMA approvals under its listings, the newest dated November 15, 2022. 47 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2210968
- Address
- ROUTE 22 WEST, P.O. Box 151, Somerville, NJ, United States, 08876
- Owner or operator
- ETHICON INC. (2210968)
- Roles
- Manufacturer
- First device listed
- December 20, 1991
- Registered through
- 2026
- Brand names listed
- Artisyn Y-Shaped Mesh, BLAKE Cardio Connector, BLAKE Silicone Drain, BONE WAX, COATED VICRYL SUTURE, Coated VICRYL Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture, Coated VICRYL Plus Antibacterial (polyglactin 910) Absorbable Suture, Cotton Umbilical Tape 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 15, 2022 | K221744 | STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| February 22, 2022 | K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture | NEW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| December 7, 2021 | K213512 | DERMABOND PRINEO Skin Closure System | OMD | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| December 21, 2020 | K201996 | Monocryl Plus Antibacterial Suture | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| August 6, 2020 | K201143 | VICRYL Mesh | FTL | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| March 25, 2020 | K192144 | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device | NEW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| December 18, 2019 | K192580 | STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| October 22, 2019 | K191373 | VICRYL Mesh | FTL | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| June 27, 2019 | K183183 | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| January 10, 2019 | K182873 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices | NEW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| September 28, 2018 | K181652 | Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| August 2, 2018 | K173923 | Temporary Cardiac Pacing Wire | LDF | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| July 26, 2018 | K181268 | PROLENE (Polypropylene) 3D Patch | FTL | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| July 2, 2018 | K180910 | ULTRAPRO Mesh and ULTRAPRO ADVANCED | FTL | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| June 28, 2018 | K180829 | PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh | FTL | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| November 1, 2017 | K170767 | Surgical Stainless Steel Suture, Stainless Steel Suture | GAQ | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| October 5, 2017 | K172089 | PROLENE Soft Polypropylene Mesh | FTL | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| April 21, 2017 | K163645 | DERMABOND PRINEO Skin Closure System | OMD | Substantially Equivalent | Ethicon, LLC | accessdata.fda.gov |
| November 25, 2015 | K152490 | DERMABOND PRINEO Skin Closure System | OMD | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| October 22, 2015 | K152096 | DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive | MPN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| October 23, 2014 | K141560 | ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE | FTL | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| May 30, 2014 | K133198 | ULTRAPRO COMFORT PLUG | FTL | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| February 28, 2014 | K132580 | COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| December 6, 2013 | K133356 | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE | GAW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| February 5, 2013 | K123114 | ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE | GDW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| June 11, 2012 | K113205 | ARTISYN Y-SHAPED MESH | OTO | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| April 7, 2010 | K093845 | ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25 | GDW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| February 17, 2010 | K092590 | PDS PLATES | NHB | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| June 5, 2007 | K071249 | ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV | FTL | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| July 14, 2006 | K061037 | PDS PLUS ANTIBACTERIAL SUTURE | NEW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| May 25, 2006 | K060713 | PROCEED SURGICAL MESH | FTL | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| August 9, 2005 | K051732 | ENDOSCOPIC APPLICATOR | GCJ | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| June 29, 2005 | K050845 | MONOCRYL PLUS ANTIBACTERIAL SUTURE | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| December 18, 2003 | K033746 | MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| October 22, 2003 | K032420 | MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| September 13, 2002 | K022269 | COATED VICRYL* (POLYGLACTIN 910) SUTURE | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| January 8, 2002 | K013718 | GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR | OTO | Substantially Equivalent | Gynecare, A Div. of Ethicon, Inc. | accessdata.fda.gov |
| November 7, 2000 | K003070 | ETHIBOND EXCEL VALVE LOOP SUTURE | DXZ | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| July 10, 2000 | K001625 | PRONOVA NONABSORBABLE SUTURE, USP | GAW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| February 23, 1999 | K984220 | MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH | FTL | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| December 18, 1996 | K964072 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED | GAN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| October 25, 1996 | K963329 | ETHICON ENDOSUTURE SYSTEM | GCJ | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| March 28, 1996 | K960653 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) | GAN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| January 9, 1995 | K946173 | STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK | GAQ | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| January 7, 1994 | K931271 | ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE | GAQ | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| August 24, 1993 | K931492 | LAPRA-TY* SUTURE CLIP | FZP | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| October 31, 1984 | K843187 | CANNULA | GEA | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| August 12, 1981 | K811872 | TEFLON PLEDGET SUTURE BUTTRESS | DXZ | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| March 13, 1981 | K810428 | VICRYL | FTL | Substantially Equivalent | ETHICON, Inc. | 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 |
|---|---|---|---|---|---|---|
| September 15, 1989 | P880047 | INTERCEED TC7 ABSORBABLE ADHESION BARRIER | MCN | 65 | June 25, 2026 | accessdata.fda.gov |
| January 28, 1982 | N18331 | PDS SUTURE (DYED) | NEW | 27 | May 12, 1997 | accessdata.fda.gov |
| October 14, 1960 | N12159 | SURGICEL BRAND ABSORBABLE HEMOSTAT | LMG | 120 | July 28, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 23, 2024 | 94496 | Class II | Ongoing | SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979. | Some applicator tips from these lots had open seals. | accessdata.fda.gov |
| November 16, 2022 | 91192 | Class II | Ongoing | PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalm | knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage | accessdata.fda.gov |
| September 20, 2022 | 90890 | Class II | Ongoing | STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12 | Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair | accessdata.fda.gov |
| August 8, 2022 | 90764 | Class II | Ongoing | PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles | Product may contain the incorrect material which could impact treatment. | accessdata.fda.gov |
| March 24, 2022 | 90016 | Class II | Ongoing | STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12]. | Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up. | accessdata.fda.gov |
| January 4, 2021 | 87088 | Class II | Terminated | Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions Product Code: DNX12 | Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach | accessdata.fda.gov |
| October 23, 2020 | 86631 | Class II | Terminated | PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm | The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit. | accessdata.fda.gov |
| September 9, 2020 | 86437 | Class II | Terminated | VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximation/ligation. Product Code: V960G | Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. The correct VICRYL suture is size 10-0, 4 inches (10 cm) in length, has monofilament construction, and a single needle. The incorrect VICRYL suture is size 6-0, 18 inches (45 cm) in length, has braided construction, and two needles | accessdata.fda.gov |
| June 10, 2020 | 85820 | Class II | Ongoing | PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870 | Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years | accessdata.fda.gov |
| January 3, 2020 | 84639 | Class II | Terminated | Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture. | Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point. | accessdata.fda.gov |
| August 28, 2019 | 84772 | Class II | Terminated | 1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201 | The product do not meet certain internal testing specifications. | accessdata.fda.gov |
| August 13, 2019 | 83715 | Class II | Terminated | STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture | The product does not meet certain internal strength testing specifications. | accessdata.fda.gov |
| April 19, 2019 | 82909 | Class II | Terminated | ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use | Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot | accessdata.fda.gov |
| March 12, 2019 | 82420 | Class II | Terminated | VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL CT VIO 8X18IN 0 S/A CT-1 CR VICRYL SUTURE | VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label. | accessdata.fda.gov |
| December 18, 2018 | 81820 | Class II | Terminated | PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approximation and/or ligation, including use in car | The sutures inside the packaging are not the same size or type as indicated on the label. | accessdata.fda.gov |
| June 8, 2018 | 80401 | Class II | Terminated | PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G (GTIN 10705031203983) | Products do not meet a tensile strength specification | accessdata.fda.gov |
| May 7, 2018 | 80306 | Class II | Terminated | PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031 | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by th | accessdata.fda.gov |
| March 7, 2018 | 79668 | Class II | Terminated | Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Application Device. | Products labeled for distribution outside the United States may have been distributed to customers in the United States. | accessdata.fda.gov |
| January 10, 2018 | 79541 | Class II | Terminated | PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle | Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture. | accessdata.fda.gov |
| November 27, 2017 | 79355 | Class II | Terminated | DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures | Ethicon discovered that specific lots of DERMABOND"PRINEO"System may not dry within the specified time after proper application, and thus may fall off. | accessdata.fda.gov |
| August 17, 2017 | 79086 | Class II | Terminated | Coated VICRYL RAPIDETM (Polyglactin 910) Suture | On August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twenty-five (25) lots of VICRYL RAPIDETM (Polyglactin 910) Suture that were distributed to the field. During finished goods testing, a suture damage was identified on a lot of VICRYL RAPIDETM Suture. During the course of the subsequent investigation, the suture also | accessdata.fda.gov |
| August 1, 2016 | 74901 | Class II | Terminated | ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature) | ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature) products are being recalled since a group of MERSILENE" Tape product codes are being supplied with an incorrect Instructions for Use (IFU) insert. | accessdata.fda.gov |
| April 11, 2016 | 71372 | Class II | Terminated | EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel. Indicated for use with manual compression as an adjunct to hemostasis for control of bleeding during adult liver surgery and soft tis | Ethicon is recalling EVARREST Fibrin Sealant Patch because the characters "0-bad" were printed in the expiration date field on the foil pouch labels of the Fibrin Patch units instead of the valid expiration date (2016-12-28). | accessdata.fda.gov |
| December 3, 2015 | 72840 | Class II | Terminated | Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of | Stability data does not substantiate the labeled two-year shelf life of affected product. | accessdata.fda.gov |
| May 8, 2015 | 71373 | Class II | Terminated | Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast absorbing surgical gut suture is a strand | Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete. | accessdata.fda.gov |
| October 17, 2014 | 69787 | Class II | Terminated | Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA. | Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products. | accessdata.fda.gov |
| February 19, 2014 | 67736 | Class II | Ongoing | Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or brid | The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination. | accessdata.fda.gov |
| September 25, 2013 | 66627 | Class II | Terminated | Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate. | Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions. | accessdata.fda.gov |
| August 21, 2012 | 63322 | Class I | Terminated | ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref 2993 SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indic | SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging. | accessdata.fda.gov |
| July 2, 2012 | 63254 | Class II | Terminated | EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. Distributed by: Ethicon, Inc. P.O. Box | Ethicon and Omrix Biopharmaceuticals have received reports of air or gas embolism occuring in association with the use of spray devices employing a pressure regulator to administer EVICEL; these events appear to be related to the use of the spray device at higher-than-recommended pressures and/or in close proximity to the tissue surface. The field correction | accessdata.fda.gov |
| April 3, 2012 | 62056 | Class II | Terminated | Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan Medical Devices Ferrosan Medical Devices A/S Sydmarken 5, DK-2860 | The lyophilized thrombin component of the Surgiflo Hemostatic Matrix kit with Thrombin has the potential to be non-sterile due to an undetected air leak which occurred during the manufacturing process. | accessdata.fda.gov |
| March 24, 2011 | 58335 | Not yet classified | Terminated | Blake Silicone Drain, 1 unit, Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151. Closed Wound Drainage Systems have been used as an adjunct in the following specialties to evacuate potentially detrimenta | There is a potential for the sterile barrier to be compromised in multiple lots of Blake silicone drains, Blake silicone drain kits, Blake cardio connectors, J-VAC reservoirs, J-VAC drain adaptors. | accessdata.fda.gov |
| February 2, 2011 | 57884 | Not yet classified | Terminated | Dermabond Topical Skin Adhesive, 2-Octo Cyanoacrylate, Sterile, Rx only, Ethicon, Inc. | Some units of Dermabond Topical Skin Adhesive and Dermabond ProPen Topical Skin Adhesive contain discolored product. | accessdata.fda.gov |
| December 29, 2010 | 57567 | Not yet classified | Terminated | Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device Product Code STRAP25. Intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures, such as hernia repa | The Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device may have the potential for the sterile barrier to be compromised due to a defect in the packaging. | accessdata.fda.gov |
| October 18, 2010 | 57021 | Not yet classified | Open, Classified | PROCEED Surgical Mesh; Product Code PCDG1; :Lot BMG618; Ethicon, Inc. a Johnson & Johnson Company. Used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging mate | There is a potential for delamination in one lot of Proceed surgical mesh. | accessdata.fda.gov |
| April 20, 2010 | 55428 | Not yet classified | Terminated | Coated VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed. Intended use: Soft Tissue approximation. | Channels in the packaging seal that can lead to suture degradation and loss of packaging integrity. Recall Z-0021-2009 was initiated in 2008. Ethicon had decided to recall all sutures product during the may to June 2007 timeframe. | accessdata.fda.gov |
| September 28, 2009 | 53535 | Not yet classified | Terminated | Gynecare Morcellex Tissue Morcellator; Manufactured by: Ethicon Women's Health & Urology; A Division of ETHICON INC, a Johnson & Johnson Company, Somerville, NJ 08876 | There is the potential for the duckbill seal to become dislodged. | accessdata.fda.gov |
| February 2, 2009 | 51049 | Not yet classified | Terminated | Coated VICRYL (Polyglactin 910) Suture, Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ 08876 Sutures are intended for general soft tissue approximation and/or ligation. | Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process. | accessdata.fda.gov |
| October 28, 2008 | 50132 | Not yet classified | Terminated | Bone Wax. Ethicon, Inc. Bone wax is available sterile in individual foil envelopes, each containing 2.5 grams, and then packaged in an individually sealed over wrap packet. The device is indicated for use to control blee | A hospital reported to their Ethicon sales representative that they had an "unmarked" box of bone was on their shipping dock that they could not receive due to lack of appropriate documentation. Upon investigation, this box was determined to be missing from a shipment between two steps of the manufacturing process. Further checks determined that two other bo | accessdata.fda.gov |
| August 11, 2008 | 49435 | Not yet classified | Terminated | VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed, Non-USP. Ethicon, Inc., a Johnson & Johnson Co.,Somerville, NJ 08876 The product is used for Soft Tissue approximation. | Package defect compromised the integrity of the primary seal, which could lead to premature suture degradation and/or impair the sterile barrier of the product. | accessdata.fda.gov |
| April 20, 2007 | 37805 | Not yet classified | Terminated | Gynecare PROLIFT Total Pelvic Repair System PFRT01 Ethicon Deutschland | The pre-printed outer box incorrectly identifies the product as GYNECARE PROLIFT Total Pelvic Floor System (Product Code PFRT01). The contents of the box actually contain GYNECARE PROLIFT Anterior Pelvic Floor System (Product Code PFRA01) | accessdata.fda.gov |
| May 4, 2006 | 35336 | Not yet classified | Terminated | Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gycolide and 10%L-lactide. | Misalignment of packaging sealing platform created open seals and/or open channels in the packaging seal causing degradation of the sutures. | accessdata.fda.gov |
| April 27, 2006 | 35335 | Not yet classified | Terminated | Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold separately and also in the following Kit Model Numbers: EDNN241, EDnn242, EDNN243, and EDNN244. | During cardiopulmonary bypass (CPB) the distal tip of the arterial cannula can become disconnected from the body of the cannula. | accessdata.fda.gov |
| February 16, 2006 | 34682 | Not yet classified | Terminated | Panacryl Synthetic Absorbable Suture. Poly(L-lactide/glycolide) Suture. Undyed (white), braided, this suture is a synthetic absorbable sterile surgical suture composed of a copolymer of 95% lactide and 5% glycolide. The | The unique absorption profile of Panacryl in the suture could act as a foreign body so that surgeons should consider its use in specific situations. | accessdata.fda.gov |
| January 4, 2006 | 34279 | Not yet classified | Terminated | PROCEED Surgical Mesh is a sterile, thin, flexible laminate mesh designed for the repair of hernias and other fascial deficiencies. The mesh product is comprised of an oxidized regenerated cellulose (ORC) fabric, and PRO | Lots of Proceed Surgical Mesh may delaminate from the polypropylene mesh during certain hernia repairs. Exposure of the polypropylene layer to the bowel prior to reperitonealization could increase the risk of adhesions and bowel fistulization. | accessdata.fda.gov |
| August 31, 2005 | 33336 | Not yet classified | Terminated | J-VAC Reservoir is a component of the J-VAC Closed Wound Drainage System. This system is a sterile, portable system used for closed wound drainage. This system is composed of two parts: the J-VAC Reservoir and Suction Dr | Two lots of J-VAC Drain Reservors were shipped to Japan prior to sterilization and were released. | accessdata.fda.gov |
| December 16, 2004 | 30711 | Not yet classified | Terminated | VERSAPOINT, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). US Distribution/Manufactured for GYNECARE, A division of Ethicon, Inc., a Johnson & Johnson Company, Somerville, NJ 08876. The produ | Deformation of the Verspoint Hysteroscopic System Connector Cable hand grips when autoclaved causing possible non-sterile electrodes. | accessdata.fda.gov |
Compare with other makers
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Updated June 25, 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.