Browse Device Recalls
2,831 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,831 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 2,831 FDA device recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 25, 2025 | Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Cat... | Sterility assurance for Ophthalmic knives. | Class II | Tecfen Medical |
| Apr 25, 2025 | Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog... | Sterility assurance for Ophthalmic knives. | Class II | Tecfen Medical |
| Apr 25, 2025 | Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel U... | Sterility assurance for Ophthalmic knives. | Class II | Tecfen Medical |
| Apr 25, 2025 | AcoSound. Model Number: LW12-BTE-M | Three issues 1. Label error: The manufacturer information in the labeling is not correct, the m... | Class III | HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. |
| Apr 25, 2025 | Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Cat... | Sterility assurance for Ophthalmic knives. | Class II | Tecfen Medical |
| 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 | 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 |
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.