Browse Device Recalls
5,540 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,540 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 5,540 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 1, 2025 | GM Helix Acqua Implant, Article Number: 140.985 | It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. | Class II | Straumann USA LLC |
| May 1, 2025 | GM Helix Acqua Implant, Article Number: 140.984 | It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. | Class II | Straumann USA LLC |
| 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 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 |
| 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 |
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.