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.
Showing 9321–9340 of 38,428 recalls
Recalled Item: API 20 E 25 STRIPS
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: API STAPH 25 STRIPS+25 MEDIA
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTISTE
The Issue: When selecting the site fraction group for treatment,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FoundationOne CDx (F1CDx)
The Issue: Reports were sent to customers without the companion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FoundationOne Liquid CDx (F1LCDx)
The Issue: Reports were sent to customers without the companion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 9 Gauge Disposable Trocars with Blunt Pushers for Use with
The Issue: No expiration dates printed on the packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Corin BIOLOX DELTA MOD HEAD
The Issue: The BIOLOX Delta Ceramic Head size 36XL is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Corin BIOLOX DELTA MOD HEAD
The Issue: The BIOLOX Delta Ceramic Head size 36XL is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InPen Diabetes Management App
The Issue: Diabetes management app may crash immediately upon opening,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control
The Issue: For one lot of CBC-3D Hematology Control, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Full Dose CE Simplex P Single Bone Cement - Indicated
The Issue: Instructions for Use (IFU) included in the packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tobra Full Dose CE Antibiotic Simplex P- Indicated for the
The Issue: Instructions for Use (IFU) included in the packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis Angiographic Catheter Extensions. Used to transport fluid from the
The Issue: There is a potential for separation at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System...
The Issue: The power backup battery, under certain conditions, may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Action INDUSTRIES INC. Port a Cath Kit
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan
The Issue: for falsely elevated specific IgE mold allergen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)-
The Issue: for falsely elevated specific IgE mold allergen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS
The Issue: for falsely elevated specific IgE mold allergen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HF Resection Electrodes
The Issue: An incompatible HF cable may be packaged with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.