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 11081–11100 of 38,428 recalls
Recalled Item: Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
The Issue: Due to a component in the hemodialysis console
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5
The Issue: Due to lumbar puncture tray manometer failure mode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SAFE-T PLUS ATRAUMATIC ADULT LP TRAY
The Issue: Due to lumbar puncture tray manometer failure mode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT
The Issue: Due to lumbar puncture tray manometer failure mode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LUMBAR PUNCTURE DRUG FREE TRAY 22G
The Issue: Due to lumbar puncture tray manometer failure mode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LUMBAR PUNCTURE TRAY ADULT 18G X 3.5
The Issue: Due to lumbar puncture tray manometer failure mode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G
The Issue: Due to lumbar puncture tray manometer failure mode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT
The Issue: Due to lumbar puncture tray manometer failure mode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY
The Issue: Due to lumbar puncture tray manometer failure mode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP
The Issue: Due to lumbar puncture tray manometer failure mode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL
The Issue: Due to lumbar puncture tray manometer failure mode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray
The Issue: Due to lumbar puncture tray manometer failure mode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PCA 4000 Curing Units
The Issue: The PCA 4000 may not fully cure EnvisionTEC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SyncVision Systems
The Issue: If FFR measurement(s) are made prior to an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diagnostic Ultrasound System
The Issue: The clip store function in the ultrasound imaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINQ II Insertable Cardiac Monitor
The Issue: Devices may lose functionality due to susceptibility to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions
The Issue: individual components have been labelled with incorrect colours
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merete PediatrOS RigidTack
The Issue: Incorrect marketing label (25 mm) was applied to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Collagen Plugs
The Issue: The sterile pouch seal may contain channels that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OPAQUE Herrick Lacrimal Plugs
The Issue: The sterile pouch seal may contain channels that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.