Browse Device Recalls

5,321 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,321 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 5,321 FDA device recalls.

Clear
DateProductReasonClassFirm
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
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 14, 2025 VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, o... Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and ca... Class II Ortho-Clinical Diagnostics, Inc.
Apr 13, 2025 Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit R... Due to non-sterile products being labeled as sterile Class II Microtek Medical, Inc.
Apr 7, 2025 Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US Incorrect labeling in which the front red pouch label did not match the actual size of the medica... Class II Ambu Inc.
Apr 7, 2025 Molding Equipment. WCM series. Model WCM-330GL-i Apic Yamada has recently discovered that certain products may be out of compliance with FDA elect... Class II Apic Yamada America
Apr 7, 2025 Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB ... Vials of implant bone granules may contain less product then specified on labeling. Class II SCIENCE & BIO MATERIALS
Mar 25, 2025 restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: H... The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 178... Class II Conformis Inc.
Mar 24, 2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 8... The associated product labeling does not adequately provide compatibility information for use of ... Class II Zimmer, Inc.
Mar 24, 2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 8... The associated product labeling does not adequately provide compatibility information for use of ... Class II Zimmer, Inc.
Mar 24, 2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Num... The associated product labeling does not adequately provide compatibility information for use of ... Class II Zimmer, Inc.
Mar 24, 2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Num... The associated product labeling does not adequately provide compatibility information for use of ... Class II Zimmer, Inc.
Mar 24, 2025 Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 7... A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline ... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 24, 2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 8... The associated product labeling does not adequately provide compatibility information for use of ... Class II Zimmer, Inc.
Mar 21, 2025 Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH... Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... Class II Baxter Healthcare Corporation
Mar 21, 2025 Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff ... Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... Class II Baxter Healthcare Corporation
Mar 20, 2025 GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA fe... DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a... Class II Agilent Technologies, Inc.
Mar 19, 2025 Medline procedure kits, labeled as: HAND, REF DYNJ902002J It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 19, 2025 Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438 It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 19, 2025 Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; ... It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 19, 2025 Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535 It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 19, 2025 Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 19, 2025 Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 19, 2025 Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; ... It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 19, 2025 Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792 It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 18, 2025 Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/... It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Med... Class II Defibtech, LLC
Mar 18, 2025 Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D... It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Med... Class II Defibtech, LLC
Mar 18, 2025 Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (... It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Med... Class II Defibtech, LLC
Mar 18, 2025 Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D... It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Med... Class II Defibtech, LLC
Mar 18, 2025 Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item nu... It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Med... Class II Defibtech, LLC
Mar 6, 2025 Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prot... The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label. Class II Fisher Diagnostics
Mar 6, 2025 Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage proth... The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label. Class II Fisher Diagnostics
Mar 5, 2025 HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 Due to incorrect the battery charger being packaged and distributed. Product labeling does not m... Class II Advanced Bionics, LLC

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.