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 13121–13140 of 38,428 recalls
Recalled Item: Operating Table System
The Issue: There is a potential for hydraulic leakage at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JUDKINS PACK
The Issue: Component Part Number: 19537LBL (LBL, SHEET OF 39,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impactis NaviKit-stereotaxic accessory for Computed Tomography systems # I10100
The Issue: Defect in the mechanical assembly of the needle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRECISE PRO RX CAROTID STENT implant system
The Issue: Distal tip may become separated from the lumen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prosthesis
The Issue: Stryker has discovered that the internal profile of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips
The Issue: Customers were not notified of previous recalls associated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips
The Issue: Customers were not notified of previous recalls associated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips
The Issue: Customers were not notified of previous recalls associated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips
The Issue: Customers were not notified of previous recalls associated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot
The Issue: This Field Action is being conducted following identification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A
The Issue: Safety shield not locking into the cannula. If
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Magellan 3 mL Syringe with Hypodermic Safety Needle
The Issue: Safety shield not locking into the cannula. If
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Magellan Hypodermic Safety Needle
The Issue: Safety shield not locking into the cannula. If
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SHARP MEDICAL PRODUCTS
The Issue: Non-conformity (holes/punctures or deep creases) in the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The ImmunoCard Mycoplasma EIA detects the presence of IgM to
The Issue: Use of the kits after incorrect storage could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mizuho CE IPX4
The Issue: There is a potential that hand control units
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Enzyme linked immunosorbent assay
The Issue: false positive HSV results. Siemens Healthcare Diagnostics,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NM/CT 860 Nuclear Medicine / CT Scanners
The Issue: GE Healthcare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NM/CT 870 DR Nuclear Medicine / CT Scanners
The Issue: GE Healthcare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NM/CT 850 Nuclear Medicine / CT Scanners
The Issue: GE Healthcare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.