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 22461–22480 of 38,428 recalls
Recalled Item: Alden HP54 Sphere Daily Wear Soft contact
The Issue: Contact lenses lack sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alden HP59 Sphere Daily Wear Soft contact
The Issue: Contact lenses lack sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ASTERA Multifocal Toric Daily Wear Soft contact
The Issue: Contact lenses lack sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bvi Beaver EdgeAhead Safety Knife
The Issue: The protective shield was retracted, and the blade
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bvi Beaver Safety Sideport Knife: (a) 1.0mm
The Issue: The protective shield was retracted, and the blade
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bvi Beaver Xstar Safety Crescent
The Issue: The protective shield was retracted, and the blade
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o
The Issue: The protective shield was retracted, and the blade
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bvi Beaver Xstar Safety Slit Knife: (a)
The Issue: The protective shield was retracted, and the blade
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stroke Fast Pack(TM)
The Issue: Stryker Neurovascular has become aware that some 3-Pack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trevo(TM) XP ProVue Procedure Pack
The Issue: Stryker Neurovascular has become aware that some 3-Pack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stroke Fast Pack(TM)
The Issue: Stryker Neurovascular has become aware that some 3-Pack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxH Slidemaker Stainer
The Issue: The shield for the Single-Tube Station on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BRAINLAB EXACTRAC VERO
The Issue: Brainlab has internally detected that under specific conditions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Everflex Self-Expanding Peripheral Stent with Entrust Delivery System...
The Issue: Stent length on the label may not match
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volcano Imaging System s5i
The Issue: On certain Impacted Systems, an unexpected Microsoft Windows
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeoBase Succinylacetone Assay Solution
The Issue: There is a potential for leaking vials for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Epi proColon Plasma Quick Kit
The Issue: The diagnostic test kit may produce invalid test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: pmi
The Issue: The firm received reports of two breakages of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CM0405 Mueller-Hinton Broth IVD
The Issue: Product may have incorrect cation information detailed on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ReNew Endocut Scissor Disposable Tip
The Issue: Certain lots of disposable laparoscopic instrument tips may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.