Browse Device Recalls

119 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 119 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 119 FDA device recalls.

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DateProductReasonClassFirm
Jul 30, 2025 Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Num... Due to a classification error in the inventory management system, specific medical devices were s... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAG... transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST... transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50B... transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS... transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Sep 17, 2024 Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing L... The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer pack... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 23, 2024 Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or with... Quarantined product was inadvertently distributed Class II Mckesson Medical-Surgical Inc. Corporate Office
Jan 9, 2024 Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mL Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical... Class II Mckesson Medical-Surgical Inc. Corporate Office
Jan 9, 2024 Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson... Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical... Class II Mckesson Medical-Surgical Inc. Corporate Office
Jan 9, 2024 Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical... Class II Mckesson Medical-Surgical Inc. Corporate Office
Jan 9, 2024 Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical... Class II Mckesson Medical-Surgical Inc. Corporate Office
Jan 9, 2024 Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST" Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical... Class II Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 a. Alcon Clear Care Contact Lens Solution Clear Care 12 oz. Solution, Model N... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 Dynarex SWAB, LEMON GLYCERIN (3/PK 25PK/BX 10BX/CS) DYNREX Catalog # 1216 Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 MORRISON MEDICAL Morrison Medical OB KIT, HARD PK SEALED W/CARDBOARD BX MORME... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 3M COMPANY 3M PAD, GROUNDING SAFETY RING Model Number: 9165 Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) ... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 MEDLINE INDUSTRIES Medline Catheter Insertion Tray Medline Foley Without Cath... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Numb... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II 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 BEAVER-VISITEC INTERNATIONAL, INC. Visitec CANNULA, LASIK IRR (10/BX)BVRVIS ... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II 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

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.