Medical devices, 2022
Shortlist up to four to read them side by side.
2,192 medical device recalls FDA’s Enforcement Report published in 2022, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,192of 2,192 medical device recallsshown with your filters
The list
- Medical device recall Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid ABX Pentra Eching Solution CP For ABX Pentra 400… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General Chemistry Creatinine Model… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum / Urine Sample 25 Tests.… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Alere Toxicology TABLET, INSTANT BLUING F/DRUGSCREEN Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Drugs of Abuse Tests: a Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall a. Alcon Clear Care Contact Lens Solution Clear Care 12 oz. Solution, Model Number: 65035820, Model Number:… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Perifix LOR Syringe Perifix 8 mL Pouch Luer Lock Tip Without Safety Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall B. Braun EVA Gravity Mixing Container 1000 mL Model Number: 2112363 Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ultracell Eye Pledget Ultracell 2 X 6 X 1 mm, Sterile Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Wetfield Eraser Bipolar Hemostatic Eraser Wet-Field Eraser 23 Gauge Tapered Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cadwell Disposable Ground Electrodes Grounding Pad 1.25 X 1.75 Inch Dimensions, Disposable Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Excelsior Heparin Sodium, Porcine, Preservative Free 100 U / mL Solution Prefilled Syringe, Partial Fill 5 mL… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kit Rapid Test Kit LeadCare II General Chemistry Blood Lead… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Strep test: a Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall a. MERIT MEDICAL SYSTEMS Aspira Dressing Kit Aspira Model Number: 4991503. b. MERIT MEDICAL SYSTEMS Aspira… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MERIT MEDICAL SYSTEMS Temno Soft Tissue Biopsy Device Temno 14 Gauge 6 cm Length Beveled Sharp Tip Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall a. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening Fecal Occult Blood Test… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NANOSONICS LTD Sonex-HL Ultrasound Probe Disinfectant trophon Sonex-HL 80 mL Bottle For Trophon EPR… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Palmero Healthcare, LLC DisCide Ultra Surface Disinfectant Cleaner Quaternary Based Manual Pour Liquid 1 gal Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STERIS CORP Revital-Ox Resert Hydrogen Peroxide High-Level Disinfectant Revital-Ox RESERT RTU Liquid 4 Liter… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GETINGE USA SALES LLC OCEAN Chest Drain System Atrium 2100 mL Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 3M COMPANY 3M PAD, GROUNDING SAFETY RING Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE INDUSTRIES Medline Catheter Insertion Tray Medline Foley Without Catheter Without Balloon Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, with Cover Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE INDUSTRIES Centurion IV Securement Kit Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Mckesson GYNECATH H/S CATHETER 5FR Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall a. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) MGM68, Model Number: 68-102800. b. METREX RESEARCH… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MedSource IV Start kit, 8inch Extension Set IV START KIT, W/SITE LOC/8” EX100/CS Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall B. BRAUN MEDICAL INC. Anesthesia Support Tray SUPPORT TRAY, +EXT SET(10/CS)ST200E Model Number: 332116 Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall a. BECTON DICKINSON BD Vacutainer C&S Preservative Urine Tube TUBE, URINE COLL PLAS 4ML (100/BX 10BX/CS),… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall a. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 3.5ML PLAS VACUTAINER (100/BX), Model… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall a. Medefil Normal Saline IV Flush Syringe NORMAL SALINE FLUSH, SYR 10ML/12ML (60/BX 16BX/CS), Model Number:… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall a. METREX RESEARCH CORP CaviCide1 DISINFECTANT, CLNR CAVICIDE1 1GL (4/CS) METREX, Model Number: 13-5000. b.… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall METREX RESEARCH CORP SPONGE, METRISPONGE W/METRIZYME Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Dynarex¿ PAD, NAIL POLISH REMOVER Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall a. DERMA SCIENCES, INC. NG Strip FASTENER, NASAL TUBE IND WRAP(25/BX), Catalog NG25. b. DERMA SCIENCES, INC.… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FISHER SCIENTIFIC Sure-Vue PIPETTE, RPR DISPENSING Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BEAVER-VISITEC INTERNATIONAL, INC Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BEAVER-VISITEC INTERNATIONAL, INC Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FISHER SCIENTIFIC Fisherbrand SWAB TRANS STUARTS DBL 50BX XXX Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FISHER SCIENTIFIC Aseptic Control¿ LUBRICATING JELLY PAP TEST 4OZ(12/PK) Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BECKMAN COULTER, INC Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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