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 19241–19260 of 38,428 recalls
Recalled Item: Fructosamine Calibrator
The Issue: The firm is conducting a Device Modification for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fructosamine Control 1
The Issue: The firm is conducting a Device Modification for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C2 CryoBalloon Controller
The Issue: The Controller does not detect overpressure in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Elition S
The Issue: During automatic tabletop movement, pressing and holding the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque
The Issue: The product may be packaged with a 5FR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System
The Issue: GE Healthcare has identified that a small number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System
The Issue: GE Healthcare has identified that a small number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion lnterventional Fluoroscopic X-ray System
The Issue: Philips has discovered through customer complaints and internal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BVI Visitec Soft Tip Cannula
The Issue: Certain lots are missing a protective sheath component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Biograph Horizon PET/CT System
The Issue: Improper design or specifications
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN...
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE Recalled by...
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC Recalled...
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC Recalled...
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN Recalled by...
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC
The Issue: for fluorescein interference to cause inaccurately elevated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sensis Vibe System
The Issue: A software error may result in a system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitros Myoglobin Calibrators
The Issue: A stability issue in the calibrators may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OMNI K1 Broach Handle
The Issue: There is a potential for the inner pin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ImplantDirect InterActive Precision IO Scan Adapter
The Issue: The peek part was loose on the titanium
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.