Medical Device Recalls

This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.

Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.

38,428 total recalls
0 this month

Showing 9301–9320 of 38,428 recalls

November 9, 2022· Biomerieux Inc

Recalled Item: PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT

The Issue: As the temperature and time out of range

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
November 9, 2022· Biomerieux Inc

Recalled Item: PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT

The Issue: As the temperature and time out of range

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
November 9, 2022· Biomerieux Inc

Recalled Item: ETEST CLINICAL ERTAPENEM ETP 32 US S30

The Issue: As the temperature and time out of range

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
November 9, 2022· Biomerieux Inc

Recalled Item: BIOBALL P.AERUGINOSA NCTC 12924 550X20

The Issue: As the temperature and time out of range

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
November 9, 2022· Biomerieux Inc

Recalled Item: ETEST CLINICAL FLUCONAZOLE FL 256 US S30

The Issue: As the temperature and time out of range

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
November 9, 2022· Biomerieux Inc

Recalled Item: ETEST CLINICAL ERYTHROMYCIN EM 256 US S30

The Issue: As the temperature and time out of range

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
November 9, 2022· Biomerieux Inc

Recalled Item: ETEST CLINICAL LEVOFLOXACIN LE 32 US S30

The Issue: As the temperature and time out of range

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
November 9, 2022· Biomerieux Inc

Recalled Item: VITEK MS CLINICAL REAGENT VITEK MS-FA

The Issue: As the temperature and time out of range

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
November 9, 2022· Biomerieux Inc

Recalled Item: PREVI COLOR GRAM REAGENT IODINE-B (NA)

The Issue: As the temperature and time out of range

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
November 9, 2022· Biomerieux Inc

Recalled Item: VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS

The Issue: As the temperature and time out of range

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
November 9, 2022· Biomerieux Inc

Recalled Item: VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS

The Issue: As the temperature and time out of range

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
November 9, 2022· Biomerieux Inc

Recalled Item: VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS

The Issue: As the temperature and time out of range

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
November 9, 2022· Biomerieux Inc

Recalled Item: ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30

The Issue: As the temperature and time out of range

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
November 9, 2022· Biomerieux Inc

Recalled Item: VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS

The Issue: As the temperature and time out of range

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
November 9, 2022· Biomerieux Inc

Recalled Item: VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T

The Issue: As the temperature and time out of range

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
November 9, 2022· Biomerieux Inc

Recalled Item: VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T

The Issue: As the temperature and time out of range

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
November 9, 2022· Biomerieux Inc

Recalled Item: ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US

The Issue: As the temperature and time out of range

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
November 9, 2022· Biomerieux Inc

Recalled Item: ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30

The Issue: As the temperature and time out of range

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
November 9, 2022· Biomerieux Inc

Recalled Item: VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS

The Issue: As the temperature and time out of range

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
November 9, 2022· Biomerieux Inc

Recalled Item: DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML)

The Issue: As the temperature and time out of range

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing