Browse Device Recalls

1,023 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,023 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 1,023 FDA device recalls — Class III.

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DateProductReasonClassFirm
May 25, 2022 a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8"... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 Skin markers: a. IZI MEDICAL PRODUCTS LLC Multi-Modality Markers SKIN MARK... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 Cooper Surgical PREFILTER, SMOKE EVAC (10/BX)CPRSRG Model Number: 52560. Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack St... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 a. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR 7X7 (5/PK) 9CENCO... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 a. DYNAREX Nice'n Fresh WIPE, BABY WET 6X6.75" (140/CN12CN/CS) Catalog # 131... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WOUND GELLING FIBERHIGH-ABS... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. ... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 a. Dynarex DRESSING, UNNA BOOT 3"X10' (12/CS), Catalog # 3453. b. Dynarex... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can ... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 Medical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM (40... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 a. DERMARITE INDUSTRIES DermaCol Collagen Dressing DermaCol Without Border Co... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 a. INTEGRA LIFESCIENCE (WND CARE) Shur-Conform Oil Emulsion Oil Emulsion Imp... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS)... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 a. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ15/8" 50YDS Catal... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 Absorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 MERIT MEDICAL SYSTEMS StayFIX FIXATION DEVICE, STAYFIX F/PERCUTAN CATH 5FR-14... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 20, 2022 Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2... Label provided for substrate vail contained incorrect expiration date. Class III Agilent Technologies, Inc.
May 13, 2022 Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx ... Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications Class III Volcano Corp
May 13, 2022 Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , R... Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications Class III Volcano Corp
May 6, 2022 KWIK-STIK" plus: Clostridium perfringens Labeling error. Class III Microbiologics Inc
Apr 14, 2022 putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY Patient chart label contains incorrect Part Number and volume amount. Class III Cerapedics, Inc.
Mar 25, 2022 CK MB Calibrator, Catalogue Number CK2393 Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value... Class III Randox Laboratories Ltd.
Feb 24, 2022 Regard Custom Procedure Kits containing BD Luer Lok Access Devices Recalled devices were packaged in convenience kits. Class III ROi CPS LLC
Feb 16, 2022 Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 1... IRISpec CA failures for glucose. Class III Beckman Coulter, Inc.
Feb 14, 2022 Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/... IFU update includes an update to the Device description, Intended Use/Indications for Use, Contr... Class III Cook Medical Incorporated
Feb 14, 2022 Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008 Labelled with an incorrect expiry date on the outer label with an extended expiry date than the ... Class III Cytocell Ltd.
Feb 14, 2022 Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-F... IFU update includes an update to the Device description, Intended Use/Indications for Use, Contr... Class III Cook Medical Incorporated
Feb 4, 2022 TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a techniq... May show unexpected locus specific signals in addition to those at 14q32. Class III Cytocell Ltd.
Feb 3, 2022 MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Nu... Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or be... Class III Volcano Corp
Jan 24, 2022 IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 30... Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as ... Class III Volcano Corp
Jan 13, 2022 HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad... Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs. Class III Physio-Control, Inc.
Jan 6, 2022 BD Vacutainer Luer Lok Access Device - intended as a sterile, single use devi... May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cel... Class III Becton Dickinson & Company
Dec 17, 2021 Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI... One ferrite ring expected to be installed on centrifugal pump system power cable may not be present. Class III LivaNova Deutschland GmbH
Dec 15, 2021 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Dec 15, 2021 20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Dec 15, 2021 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Dec 15, 2021 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Dec 15, 2021 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Nov 19, 2021 Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU T... The Instructions for Use provided with the device contained information intended for use of a mec... Class III Ki Mobility Llc
Nov 10, 2021 iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery S... The dosage information on the pouch is incorrect; the primary carton label is correct. Class III Tapemark Company
Oct 15, 2021 VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 ... Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-... Class III Ortho-Clinical Diagnostics, Inc.
Oct 14, 2021 SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary by... Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 202... Class III Cardiac Assist, Inc
Oct 5, 2021 A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Con... The Control Level I material value was showing results exceeding the upper limit of the acceptabl... Class III Primus Corporation dba Trinity Biotech
Oct 5, 2021 Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-00... The Control Level I material value was showing results exceeding the upper limit of the acceptabl... Class III Primus Corporation dba Trinity Biotech
Jul 29, 2021 Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - P... Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instru... Class III Sentinel CH SpA
Jul 15, 2021 Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15,... Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expi... Class III Cell Marque Corporation
Jul 15, 2021 Pneupac paraPac plus 300 ventilator kit, REF P300NGB Two devices were labeled with the same serial number Class III Smiths Medical ASD Inc.
Jul 12, 2021 Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent. Deterioration in the stability of the reagents which has resulted in lower than expected or out o... Class III Stanbio Laboratory, LP

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.