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 22141–22160 of 38,428 recalls
Recalled Item: ImmunoCAP Allergen c6
The Issue: The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COACH¿ Self-Adhering Sports Wrap (size: 2in)
The Issue: Johnson & Johnson Consumer Inc. is initiating a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap
The Issue: Johnson & Johnson Consumer Inc. is initiating a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 2in)
The Issue: Johnson & Johnson Consumer Inc. is initiating a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 1in)
The Issue: Johnson & Johnson Consumer Inc. is initiating a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COACH¿ Self-Adhering Sports Wrap (size: 3in)
The Issue: Johnson & Johnson Consumer Inc. is initiating a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: c6000
The Issue: Complaints have been received concerning questionable results on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap
The Issue: Johnson & Johnson Consumer Inc. is initiating a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical
The Issue: Complaints have been received concerning questionable results on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Modular E 170 Analyzer: Immunoassay Chemistry Analyzer
The Issue: Complaints have been received concerning questionable results on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere iScreen Dx Urine Drug Screen Card
The Issue: The kit box label incorrectly identifies Phencyclidine (PCP),
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Uterine Electromyographic Monitor -Monica IF24 Interface System Product...
The Issue: if the cables of the Monica IF24 System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product
The Issue: if the cables of the Monica Novii System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Confidence Plus Kit Spinal Cement System
The Issue: Certain lots of the spinal cement may contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a
The Issue: The calibration for the affected batch of analyzers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROW ENDURANCE" Extended Dwell Peripheral Catheter System
The Issue: Certain lots of peripheral catheter systems may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Camera System
The Issue: The radiated emission from the TruVidia" Wireless Receiver
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrightView Model 882480 Product Usage: BrightView and BrightView X are
The Issue: During collimator exchange, the alignment of the collimator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Precedence 6 Model # 882351 Product Usage: Precedence (cleared as
The Issue: During collimator exchange, the alignment of the collimator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrightView XCT Model 882482 Product Usage: BrightView XCT is a
The Issue: During collimator exchange, the alignment of the collimator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.