Browse Device Recalls

39,949 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,949 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 39,949 FDA device recalls.

DateProductReasonClassFirm
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 Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of... Class I Baxter Healthcare Corporation
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 iBOT PMD with software version 01.05.24. Personal Mobility Device. Software issue that could potentially lead to the device tipping over from Balance Mode. Class II Mobius Mobility LLC
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
Apr 23, 2025 Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque u... Potential breach of sterile barrier packaging. Class II Mozarc Medical US LLC
Apr 23, 2025 DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software... A new motor/encoder and cable was introduced into instruments manufactured starting with serial n... Class II Beckman Coulter, Inc.
Apr 23, 2025 MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. Potential breach of sterile barrier packaging. Class II Mozarc Medical US LLC
Apr 23, 2025 Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque ... Potential breach of sterile barrier packaging. Class II Mozarc Medical US LLC
Apr 23, 2025 DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software... A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assa... Class II Beckman Coulter, Inc.
Apr 23, 2025 Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque... Potential breach of sterile barrier packaging. Class II Mozarc Medical US LLC
Apr 23, 2025 Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque ure... Potential breach of sterile barrier packaging. Class II Mozarc Medical US LLC
Apr 23, 2025 MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical s... The MIRA Surgical System Software Version 4.0.3 loaded on the Surgeon Control Console may have th... Class II VIRTUAL INCISION CORPORATION
Apr 23, 2025 Apo B Reagent, REF: OSR6143 The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value... Class III Beckman Coulter Ireland, Inc.
Apr 22, 2025 ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400... Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may r... Class II ICU Medical, Inc.
Apr 22, 2025 Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACC... Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequa... Class I MEDLINE INDUSTRIES, LP - Northfield
Apr 22, 2025 ICU Medical Plum Solos, Item number 400011001; infusion pump Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may r... Class II ICU Medical, Inc.
Apr 22, 2025 Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 ro... Firm has received an increase in reports regarding inadvertent instrument lockout during surgical... Class I Ethicon Endo-Surgery Inc
Apr 22, 2025 Brand Name: Catalyst+ Product Name: C4D software used in conjunction with ... Software issue with scanning equipment that can results in the filed rotation not being applied c... Class II C-RAD POSITIONING AB
Apr 22, 2025 Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SK... Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequa... Class I MEDLINE INDUSTRIES, LP - Northfield
Apr 22, 2025 3M Ranger Irrigation Fluid Warming Set, REF 24750 Notice was issued to clarify flow rates related to the inlet fluid temperature. Class II 3M Company
Apr 22, 2025 Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A... Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequa... Class I MEDLINE INDUSTRIES, LP - Northfield
Apr 21, 2025 Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon... Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual c... Class II Capnia Inc
Apr 21, 2025 LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KN... Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene... Class II American Contract Systems, Inc.
Apr 21, 2025 BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: ... Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in bloo... Class II Becton Dickinson Infusion Therapy Systems, Inc.
Apr 21, 2025 BIB Balloon in Balloon Dilatation Catheter. Model Number: 420 Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub... Class II Numed Inc
Apr 17, 2025 WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments. Incorrect blister labelling. Class II Straumann USA LLC
Apr 17, 2025 Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100 Due to customer complaints, there is a potential for users to be unable to or find it difficult t... Class I C.R. Bard Inc

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.