Data / Medical devices / United States / Coopersurgical, Inc.
Coopersurgical, Inc.: FDA-registered device maker in Trumbull, CT, United States, 211 510(k) clearances
Coopersurgical, Inc. is registered with the FDA (registration 1216677) in Trumbull, CT, United States. It lists 98 device types. The FDA files 211 510(k) clearances under its listings, the newest dated August 19, 2026. 71 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1216677
- Address
- 95 Corporate Drive, Trumbull, CT, United States, 06611
- Owner or operator
- COOPERSURGICAL, INC. (9002384)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 9, 1977
- Registered through
- 2027
- Brand names listed
- 10100060A, 10105060A, 10100500A, 10100060D, 10105060D, 10100500D, 10100060F, 10105060F, 10100500F, 10100060M, 10105060M, 10100500M, 10264010A, 10984010A, 10264010D, 10984010D, 10264010F, 10984010F, 10300060, 10301010, 10305060, 10310060, 10311010, 10315060 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 211.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 19, 2026 | K261083 | Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK) | MQG | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| August 29, 2025 | K243799 | Fetal Pillow | PWB | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| April 11, 2025 | K250438 | CooperSurgical Milex® Pessaries | HHW | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| October 28, 2022 | K223098 | Bakri Essential Postpartum Balloon | OQY | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| October 28, 2022 | K223064 | ALLY II Uterine Positioning System (UPS) | LKF | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| July 17, 2020 | K200680 | Synvitro Hyadase | MQL | Substantially Equivalent | Origio A/S, A Coopersurgical Company | accessdata.fda.gov |
| May 21, 2020 | K201086 | Advincula Delineator Uterine Manipulator | HEW | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| January 14, 2020 | K191020 | G210 InviCell Plus with SignipHy pH monitoring | PUB | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| June 12, 2019 | K191291 | Wallace Dual Lumen Oocyte Recovery System | MQE | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| May 15, 2019 | K190639 | Endosee System | HIH | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| May 10, 2019 | K182959 | Wallace Dual Lumen Oocyte Recovery System | MQE | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| July 17, 2018 | K171272 | Cook-Swartz Doppler Flow Probe | ITX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| March 14, 2018 | K180429 | Advincula Delineator Uterine Manipulator | HEW | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| March 8, 2018 | K173075 | ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) | MQK | Substantially Equivalent | Dxnow, Inc. | accessdata.fda.gov |
| March 2, 2018 | K173731 | SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) | MQL | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| March 2, 2018 | K173624 | ORIGIO® Handling without phenol red (Cat. No. 8310), ORIGIO® Handling with phenol red (Cat. No. 8311) | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| October 13, 2017 | K172197 | SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| July 27, 2017 | DEN150053 | FETAL PILLOW | PWB | Unknown | Safe Obstetric Systems, Ltd. | accessdata.fda.gov |
| July 13, 2017 | K170660 | Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula | HIH | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| April 4, 2017 | K170560 | SAGE Vitrification Kit and SAGE Vitrification Warming Kit | MQL | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| March 31, 2017 | K170622 | Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component | OQY | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| January 23, 2017 | K161275 | EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip | MQH | Substantially Equivalent | Research Instruments Limited | accessdata.fda.gov |
| July 22, 2016 | K153267 | ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| March 18, 2016 | K151845 | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) | MPO | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| February 29, 2016 | K152932 | BlastGen | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| December 21, 2015 | K153092 | Ally Uterine Positioning System | LKF | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| July 21, 2015 | K143650 | CooperSurgical Advincula Delineator Uterine Manipulator | HEW | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| February 26, 2015 | K143415 | Air Bubble Based Infuser (ABBI) | LKF | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| February 17, 2015 | K142991 | LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA | MQL | Substantially Equivalent | Life Global Group, LLC | accessdata.fda.gov |
| January 20, 2015 | K143498 | LifeGlobal Global HP | MQL | Substantially Equivalent | Life Global Group, LLC | accessdata.fda.gov |
| November 25, 2014 | K141523 | ALLY UPS | LKF | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| October 23, 2014 | K140754 | COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM | HEX | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| July 2, 2014 | K132384 | U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA | HIH | Substantially Equivalent | Endosec Corporation | accessdata.fda.gov |
| June 16, 2014 | K140317 | EMBRYOGEN | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| May 14, 2014 | K133912 | ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| May 7, 2014 | K132870 | Origio Gas Line Filter | MQG | Substantially Equivalent | Origio, Inc. | accessdata.fda.gov |
| April 29, 2014 | K133387 | ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| April 16, 2014 | K133707 | SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| September 27, 2013 | K131206 | COOK CERVICAL RIPENING BALLOON | PFJ | Substantially Equivalent | Cook, Inc. | accessdata.fda.gov |
| March 8, 2013 | K123151 | ENDOSEE MODEL 8000 U-SCOPE | HIH | Substantially Equivalent | Endosee Corp | accessdata.fda.gov |
| July 27, 2012 | K121604 | ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT | FER | Substantially Equivalent | Obp Corporation | accessdata.fda.gov |
| May 3, 2012 | K112083 | LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES | MQL | Substantially Equivalent | <Genx> Intl., Inc. | accessdata.fda.gov |
| March 16, 2012 | K120373 | INSORB ABSORBALBE STAPLE | GDW | Substantially Equivalent | Incisive Surgical, Inc. | accessdata.fda.gov |
| March 16, 2011 | K110347 | DOPPLER MONITOR | DPW | Substantially Equivalent | Cook Vascular, Inc. | accessdata.fda.gov |
| February 15, 2011 | K103693 | VANTAGE ABI | DXN | Substantially Equivalent | Summit Doppler Systems, Inc. | accessdata.fda.gov |
| January 14, 2011 | K092963 | GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 | MQL | Substantially Equivalent | Genx Intl., Inc. | accessdata.fda.gov |
| August 27, 2010 | K100367 | MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229 | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| August 19, 2010 | K101816 | STN PROBE | ITX | Substantially Equivalent | Summit Doppler Systems, Inc. | accessdata.fda.gov |
| June 3, 2010 | K092667 | GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT | MQL | Substantially Equivalent | Genx Intl., Inc. | accessdata.fda.gov |
| April 5, 2010 | K092578 | LIFEGLOBAL PROTEIN SUPPLEMENT | MQL | Substantially Equivalent | Genx Intl., Inc. | accessdata.fda.gov |
| December 24, 2009 | K093393 | LIFEDOP MODEL 300ABI | JAF | Substantially Equivalent | Summit Doppler Systems, Inc. | accessdata.fda.gov |
| December 4, 2009 | K091838 | OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK | HIH | Substantially Equivalent | Obp Medical | accessdata.fda.gov |
| September 9, 2009 | K091937 | OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM | HIB | Substantially Equivalent | Obp Corporation | accessdata.fda.gov |
| April 24, 2009 | K083509 | LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA | MQL | Substantially Equivalent | Genx Intl., Inc. | accessdata.fda.gov |
| March 31, 2009 | K090499 | LIFEDOP MODEL, L350R | MAA | Substantially Equivalent | Summit Doppler Systems, Inc. | accessdata.fda.gov |
| October 10, 2008 | K073522 | VITRIFICATION KIT & VITRIFICATION WARMING KIT | MQL | Substantially Equivalent | Sage In-Vitro Fertilization, Inc. | accessdata.fda.gov |
| September 19, 2008 | K081639 | ICSI CUMULASE | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| August 13, 2008 | K080395 | SUNIVF DISHES | MQK | Substantially Equivalent | <Genx> Intl., Inc. | accessdata.fda.gov |
| January 23, 2008 | K063223 | MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS | HDW | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| December 19, 2006 | K063600 | VISTA AVS | JAF | Substantially Equivalent | Summit Doppler Systems, Inc. | accessdata.fda.gov |
| October 20, 2006 | K061651 | FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 | HGI | Substantially Equivalent | Apple Medical Corp. | accessdata.fda.gov |
| October 2, 2006 | K061145 | SPERMSLOW | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| July 28, 2006 | K060983 | BIOPSY MEDIUM, MODEL REF 1062 | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| July 14, 2006 | K053646 | INVITRO MATURATION MEDIA | MQL | Substantially Equivalent | Sage In-Vitro Fertilization, Inc. | accessdata.fda.gov |
| May 19, 2006 | K053552 | GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA | MQL | Substantially Equivalent | <Genx> Intl., Inc. | accessdata.fda.gov |
| May 9, 2006 | K053551 | MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL | MQL | Substantially Equivalent | <Genx> Intl., Inc. | accessdata.fda.gov |
| April 13, 2006 | K052457 | PICSI SPERM SELECTION DEVICE | MQK | Substantially Equivalent | Biocoat, Inc. | accessdata.fda.gov |
| April 10, 2006 | K060410 | ECHOHEART TRANSVAGINAL DOPPLER PROBE | HEK | Substantially Equivalent | Summit Doppler Systems, Inc. | accessdata.fda.gov |
| April 26, 2005 | K050256 | APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR | GAD | Substantially Equivalent | Apple Medical Corp. | accessdata.fda.gov |
| November 22, 2004 | K041284 | MEDICULT IVM SYSTEM | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| September 29, 2004 | K041435 | THE STRIPPER PGD | MQH | Substantially Equivalent | Mid-Atlantic Diagnostics, Inc. | accessdata.fda.gov |
| June 25, 2004 | K040530 | MEDIA CULTURE SYSTEM | MQL | Substantially Equivalent | <Genx> Intl., Inc. | accessdata.fda.gov |
| December 19, 2003 | K033084 | WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER | MQF | Substantially Equivalent | Portex , Ltd. | accessdata.fda.gov |
| November 24, 2003 | K032874 | HBA SPERM-HYALURONAN BINDING ASSAY | POV | Substantially Equivalent | Biocoat, Inc. | accessdata.fda.gov |
| August 27, 2003 | K030525 | CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES | MQG | Substantially Equivalent | Mid-Atlantic Diagnostics, Inc. | accessdata.fda.gov |
| August 20, 2003 | K030490 | ISM1+, IMS2+, AND UTM+ | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| June 27, 2003 | K031486 | BLASTFREEZE AND BLASTTHAW | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| June 24, 2003 | K031228 | SYNVITRO HYADASE | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| January 3, 2003 | K024197 | LIFEDOP DOPPLER | KNG | Substantially Equivalent | Summit Doppler Systems, Inc. | accessdata.fda.gov |
| December 13, 2002 | K023383 | COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER | MQF | Substantially Equivalent | Cooper Surgical | accessdata.fda.gov |
| December 11, 2002 | K023379 | COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER | MQF | Substantially Equivalent | Cooper Surgical | accessdata.fda.gov |
| August 23, 2002 | K022332 | LITE MINERAL OIL | MQL | Substantially Equivalent | <Genx> Intl., Inc. | accessdata.fda.gov |
| July 12, 2002 | K021224 | ENDOCERVICAL BLOCK NEEDLE | HEE | Substantially Equivalent | Wallach Surgical Devices, Inc. | accessdata.fda.gov |
| June 3, 2002 | K020711 | WALLACH LOOP ELECTRODE | GEI | Substantially Equivalent | Wallach Surgical Devices, Inc. | accessdata.fda.gov |
| April 24, 2002 | K020954 | H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY | LKF | Substantially Equivalent | Ackrad Laboratories | accessdata.fda.gov |
| April 16, 2002 | K020951 | H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 | LKF | Substantially Equivalent | Ackrad Laboratories | accessdata.fda.gov |
| February 15, 2002 | K014005 | APPLE MEDICAL MOBIUS ELASTIC RETRACTOR | GCJ | Substantially Equivalent | Apple Medical Corp. | accessdata.fda.gov |
| February 11, 2002 | K012811 | BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B | MQH | Substantially Equivalent | Humagen Fertility Diagnostics, Inc. | accessdata.fda.gov |
| February 11, 2002 | K012277 | PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE | HHW | Substantially Equivalent | Sims Portex , Ltd. | accessdata.fda.gov |
| December 17, 2001 | K013972 | H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005 | LKF | Substantially Equivalent | Ackard Laboratories | accessdata.fda.gov |
| October 11, 2001 | K012935 | THECURVE, ITEM 507 | MFD | Substantially Equivalent | Select Medical Systems, Inc. | accessdata.fda.gov |
| August 3, 2001 | K012068 | WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S | MQE | Substantially Equivalent | Sims Portex , Ltd. | accessdata.fda.gov |
| July 30, 2001 | K011532 | MITYVAC | HDB | Substantially Equivalent | Prism Enterprises, Inc. | accessdata.fda.gov |
| March 22, 2001 | K003404 | SUPRASPERM SYSTEM | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| March 22, 2001 | K003163 | SYNVITRO FLUSH | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| December 21, 2000 | K003734 | SERUM PROTEIN SUBSTITUTE | MQL | Substantially Equivalent | Sage Biopharma | accessdata.fda.gov |
| October 3, 2000 | K002836 | MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE | MQL | Substantially Equivalent | Sage Biopharma | accessdata.fda.gov |
| September 15, 2000 | K001486 | GENX CODA AIR PURIFICATION SYSTEM | MQG | Substantially Equivalent | <Genx> Intl., Inc. | accessdata.fda.gov |
| July 20, 2000 | K991279 | MEDI-CULT UNIVERSAL IVF-MEDIUM | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| June 15, 2000 | K001545 | PIPET CURET | HHK | Substantially Equivalent | Milex Products, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 11, 2026 | 99643 | Class I | Ongoing | INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710, 44-2712, 44-2715. | Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored. | accessdata.fda.gov |
| June 11, 2025 | 97028 | Class II | Ongoing | HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures. | The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile. | accessdata.fda.gov |
| November 15, 2024 | 95741 | Class II | Ongoing | Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproducti | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately. | accessdata.fda.gov |
| July 31, 2024 | 95232 | Class II | Ongoing | Silver-Plated Copper Sims Uterine Sound, Part Number 64-600 | During the manufacturing process the devices were laser-marked with the incorrect part number. | accessdata.fda.gov |
| February 16, 2024 | 95246 | Class II | Ongoing | Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A | Low concentration of sodium pyruvate in the wash could compromise gamete development | accessdata.fda.gov |
| December 20, 2023 | 93688 | Class II | Ongoing | global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer. | The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage. | accessdata.fda.gov |
| August 29, 2023 | 93822 | Class II | Ongoing | Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-Thomason Suture Passer, | Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays. | accessdata.fda.gov |
| February 13, 2023 | 91794 | Class II | Ongoing | Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060 | It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and development. | accessdata.fda.gov |
| December 15, 2022 | 91438 | Class II | Ongoing | BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD) | The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo. | accessdata.fda.gov |
| October 20, 2022 | 91047 | Class II | Ongoing | NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540 | Firm has received 11 complaints involving a loose or detached metal clips, including 3 cases where the metal clip was ingested by the patient, and 3 cases where the metal clip was removed from the patient's mouth. In one case, the patient suffered a laceration to the throat. | accessdata.fda.gov |
| August 12, 2022 | 90782 | Class II | Ongoing | Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I model is no longer produced, but the legacy humidifier bottle component design can also be used wit | There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the sterile barrier may result in use of an unsterilized device, which may cause contamination and degradation or loss of embryo during incubation. | accessdata.fda.gov |
| June 13, 2022 | 90469 | Class II | Ongoing | LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055 | There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5 seconds as indicated in the English version. | accessdata.fda.gov |
| April 1, 2022 | 90042 | Class II | Ongoing | VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap. | Products in this lot may have compromised barrier seals, introducing a risk to sterility. | accessdata.fda.gov |
| March 31, 2022 | 93239 | Class II | Ongoing | Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial th | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure | accessdata.fda.gov |
| September 29, 2021 | 88648 | Class II | Ongoing | LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120 | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case. | accessdata.fda.gov |
| June 30, 2021 | 88277 | Class II | Terminated | Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 | Units are displaying output readings that differ from the measurements taken using a Gas Analyzer. When the display is reading a target setting of 5%, an external meter is reading between 3% and 12% and the Incubator does not alarm. May result in loss of embryo during storage. | accessdata.fda.gov |
| April 30, 2021 | 87920 | Class II | Terminated | CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional procedures, and for electro-fulguration procedures of the lower genital | The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode. | accessdata.fda.gov |
| April 23, 2021 | 87849 | Class II | Ongoing | The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2 | The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N 34131-03 as required. | accessdata.fda.gov |
| January 21, 2021 | 87228 | Class II | Terminated | Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4" (57 mm) with Kit, 2) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-1/4, 2-1/4" (57 mm) without | The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a short stem (1.670 or 1.960 nominal height) as required. The length discrepancy does not meet the released print dimensions. | accessdata.fda.gov |
| September 8, 2020 | 86479 | Class II | Terminated | MediCult Vitrification Cooling Media, Model Number 12284001F | There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it contains an Equilibration Medium (P/N: 12220001) rather than the Vitrification Medium (P/N: 12230001) as indicated on the remainder of the label. | accessdata.fda.gov |
| June 3, 2020 | 85787 | Class II | Terminated | COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176 | Mislabeled: Printing on the top web or Tyvek lid of the individual product blister tray indicating that it contains a Pipet Current or Part Number MX140 and the display box indicating the correct Os FinderTM Cervical Dilators, Part Number 1176. The product in the individual product package is the correct Os Finder Cervical Dilator | accessdata.fda.gov |
| April 9, 2020 | 85544 | Class II | Terminated | CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21 | The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators. | accessdata.fda.gov |
| February 28, 2020 | 85139 | Class III | Terminated | Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washe | Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years. | accessdata.fda.gov |
| December 13, 2019 | 84443 | Class II | Terminated | ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a sterile, single-use cannula that is part of the Advanced Endosee Sy | Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5). | accessdata.fda.gov |
| October 16, 2019 | 84132 | Class II | Terminated | Quantam 2000 Electrosurgical Generator, Part number 909075. | Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot pedal is used for activation. | accessdata.fda.gov |
| September 5, 2019 | 83108 | Class III | Terminated | Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laborat | The touchpad may not work properly after cleaning. | accessdata.fda.gov |
| August 19, 2019 | 83704 | Class III | Terminated | LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures. | Discrepancy between the correct expiration dates on the individual pouches inside the boxes and incorrect expiration dates on the outer boxes, where the month and day were reversed. | accessdata.fda.gov |
| July 8, 2019 | 83110 | Class II | Terminated | TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The TransWarmer Warming Infant Transport Mattress is gel-filled, disposable mattress that provides heat for up to two hours when cold stress i | The firm updated the IFU in April 2019 to clarify that use of the TRANSWARMER Mattress with other heat producing devices, such as an incubator, is prohibited and could lead to serious health consequences, such as skin burns. some products do not contain the updated IFU. | accessdata.fda.gov |
| June 18, 2019 | 83100 | Class II | Terminated | LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120 | The products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal. | accessdata.fda.gov |
| June 14, 2019 | 83105 | Class II | Terminated | Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy | The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences, such as lacerations. | accessdata.fda.gov |
| April 23, 2019 | 82821 | Class II | Terminated | LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Eva | 2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses. | accessdata.fda.gov |
| March 27, 2019 | 82663 | Class II | Terminated | ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0 | ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent | accessdata.fda.gov |
| September 4, 2018 | 81037 | Class II | Terminated | Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve a | There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection. | accessdata.fda.gov |
| September 4, 2018 | 80993 | Class II | Terminated | Colpo-Pneumo Occluder, Part CPO-6 | The seal of the sterile pouch may be compromised, thereby increasing the risk of infection. | accessdata.fda.gov |
| March 12, 2018 | 79828 | Class II | Terminated | Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: | Products have been packaged with an incorrect product size. | accessdata.fda.gov |
| March 12, 2018 | 79825 | Class II | Terminated | 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number Product Usage: The Apple-Hunt Secondary Cannulas are indicated for use in laparoscopic surgical procedures to provide a pat | Products have been packaged with the wrong Trocar length type. | accessdata.fda.gov |
| October 6, 2017 | 79213 | Class II | Terminated | Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The pr | The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe | accessdata.fda.gov |
| April 10, 2017 | 76980 | Class II | Terminated | CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural la | The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains the product and the Instructions for Use (IFU) correctly states that the pessary is manufactured from latex rubber. | accessdata.fda.gov |
| August 25, 2016 | 75094 | Class III | Terminated | Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium. Product Number: ART -8017 SAGE In Vitro Fertilization, Inc. A CooperSurgical Company 95 Corporate Drive Trumbull, CT 06611 USA | Products contain international package insert and not the correct USA package insert | accessdata.fda.gov |
| February 16, 2016 | 73329 | Class II | Terminated | Milex Arcing Diaphragm Size 95; Model Number: MXWS95 | The products have been identified to contain an incorrect size Diaphragm. | accessdata.fda.gov |
| September 14, 2015 | 72204 | Class III | Terminated | MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage: The Coopersurgical MILEX SILICONE PESSARY is used to manage a number of gynecologic issues including pelvic support defects and str | The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packaging. While the Pessary pouch is marked with correct size, an incorrect label on the packaging does not meet the required release specification. | accessdata.fda.gov |
| September 1, 2015 | 72107 | Class III | Terminated | CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061 | Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%) | accessdata.fda.gov |
| July 6, 2015 | 71597 | Class II | Terminated | Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100; PN 24401 LIQUID INFANT HEEL WARMER | Product marketed without a 510(k) | accessdata.fda.gov |
| June 19, 2015 | 71582 | Class II | Terminated | Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used for progressive vaginal dilation therapy involving the treatment of vaginismus | Incorrect expiration date on outer carton kit label | accessdata.fda.gov |
| May 20, 2015 | 71329 | Class II | Terminated | MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80 | A diaphragm size 80 labeled box was incorrectly packaged with a size 85. | accessdata.fda.gov |
| May 18, 2015 | 71308 | Class II | Terminated | Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators during gynecological laproscopic procedures Model: Ally UPS | Design of device may expose user to injury to fingers or body parts | accessdata.fda.gov |
| April 13, 2015 | 71313 | Class II | Terminated | McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures | Small sized specula were incorrectly packaged in printed bags for the medium sized speculum | accessdata.fda.gov |
| March 20, 2015 | 70828 | Class II | Terminated | Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery. | The pad printing around the suture entry holes on the 15mm Suture Guide included in the kit may not have been appropriately manufactured resulting in the pad printing flaking off around the entry holes. | accessdata.fda.gov |
| March 9, 2015 | 70829 | Class II | Terminated | WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162 | Internal gas line may malfunction causing the line to burst under pressure. | accessdata.fda.gov |
| February 9, 2015 | 70502 | Class II | Terminated | CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in, 35 mm Part Number: MXKPEC02 | Incorrect size printed on the Milex Pessary Kit packaging label | accessdata.fda.gov |
| January 26, 2015 | 70286 | Class II | Terminated | CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle heat to increase blood flow and enhance infant blood sample collection | Products without expiration date have the remote potential for minor burn | accessdata.fda.gov |
| October 27, 2014 | 69642 | Class III | Terminated | Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue from within the uterine cavity on an outpatient basis. The primary uses for this device | The product has been identified to contain an incorrect curette type. | accessdata.fda.gov |
| October 27, 2014 | 69636 | Class II | Terminated | CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital | Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode | accessdata.fda.gov |
| September 30, 2014 | 69500 | Class III | Terminated | CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues in | Incorrect expiration date printed on the MILEX PESSARY KIT packaging | accessdata.fda.gov |
| July 3, 2014 | 68754 | Class II | Terminated | CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography. | Unsealed pouches. | accessdata.fda.gov |
| June 20, 2014 | 68592 | Class II | Terminated | Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-90 PP-9-90 PP-5.75-90PL PP-9-90PL | Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration | accessdata.fda.gov |
| May 13, 2014 | 68317 | Class II | Terminated | Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005 | Sterility of the device may be compromised due to unsealed pouch | accessdata.fda.gov |
| May 1, 2013 | 70368 | Class II | Terminated | CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: NovaPlus TransWarmer Infant Heat Therapy Mattress with WarmGel. P/N V6390 Provides warmth during transport of infant within the h | Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification | accessdata.fda.gov |
| February 26, 2013 | 64531 | Class III | Terminated | Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex Part Number: MXPCON04 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or b | Pessary mislabeled outer package may not reflect the size of the product contained in the package | accessdata.fda.gov |
| February 26, 2013 | 64528 | Class II | Terminated | LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrin | LEEP RediKit Products (for use in Loop Electrosurgical Excision Procedures) have Xylocaine (Lidocaine) HCL (2%) listed on the tray lid label but this is not included in the contents of the kit, which contained Polocaine (Mepivacaine) HCL (3%) instead (which was not listed on the tray label). | accessdata.fda.gov |
| February 26, 2013 | 64510 | Class II | Terminated | Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception. | Incorrect size was printed on the outer product packaging. | accessdata.fda.gov |
| October 31, 2012 | 63681 | Class II | Terminated | Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallo | Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle | accessdata.fda.gov |
| November 28, 2011 | 60824 | Not yet classified | Terminated | ORIGIO MIDATLANTIC DEVICES CRYOPETTE (r) Rx only Single use only CRY-PETTE-CL LOT 123456 2013-10-10 Exp. date *** MADE IN THE USA STERILE R ***Origio, Inc. 3400 Hunter's Way, Charlottesville, VA 22911 www.origio.com The | Cryopettes were rupturing during the warming process following vitrification. | accessdata.fda.gov |
| September 23, 2011 | 60101 | Not yet classified | Terminated | DICOM Option for the Norland Illuminatus Software Revs 4.2.0 though 4.3.1. Models Norland XR-600, XR-800, XR-46, EXCELL, XR-36 and Eclipse DXA Bone Densitometers. The XR 46 performs DXA scans of the AP Spine, Hip, Forear | The DICOM Software, Norland Illuminatus DXA Software with the DICOM Option (Part Number 434A133) version 4.2.0 through 4.3.1, which is installed on the XR-600, XR-800, XR-46 and EXCELL DXA Bone Densitometers, could lead to improper patient information getting into a previous patient's record. | accessdata.fda.gov |
| September 29, 2009 | 53436 | Not yet classified | Terminated | Wallach LL100 Cryosurgical Freezer CO2 Unpinned Yoke System CO2 Model: 900000. | CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve. | accessdata.fda.gov |
| January 16, 2008 | 46377 | Not yet classified | Terminated | M-Style Mushroom Cup Vacuum Assisted Delivery System used with hand pump (Ref: 10007LP). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated for use during vaginal delivery | Vacuum Assisted Delivery System may have a loss of vacuum, or the cup will not release from the baby's head. A loss of vacuum may delay delivery and require the use of forceps and/or c-section for delivery. An inability to remove the cup from the head may delay delivery and/or prevent the user from applying forceps if necessary. This may result in serious in | accessdata.fda.gov |
| June 6, 2007 | 38072 | Not yet classified | Terminated | Wallach Cryotip T-00337 Anorectal Tip used with the Cryosurgical LL100 or LL50X Cryosurgical Systems Reference: 900218 | The tip may separate from the probe. | accessdata.fda.gov |
| May 8, 2007 | 38348 | Not yet classified | Terminated | IVF Pasteur Pipettes, glass, cotton plugged, length 9", in boxes of 90 consisting of 30 nylon tube packages of 3 pipettes each. Item # PP-9-90PL. Boxes are labeled in part ***Humagen Fertility Diagnostics, Inc. 2400 Hunt | Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated. | accessdata.fda.gov |
| March 10, 2006 | 34810 | Not yet classified | Terminated | Fischer Cone Biopsy Excisor - Small Model: | Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient. | accessdata.fda.gov |
| November 1, 2005 | 33940 | Not yet classified | Terminated | Milex 60cc Handy-Vak Locking Syringe Ref: MX500 | Potential for the plunger to separate from the piston | accessdata.fda.gov |
| August 17, 2004 | 29970 | Not yet classified | Terminated | Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System Product No: 10047 | Product is mislabeled as a Mushroom Cap Vacuum but actually contains a Bell Style Assisted Delivery System | accessdata.fda.gov |
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Updated September 18, 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.