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 34361–34380 of 38,428 recalls
Recalled Item: VerifyNow IIb/IIIa Test
The Issue: Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trevo Pro 4 Stent Retriever
The Issue: Product shipped to US customers had non U.S
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Large Rickham -Style Reservoir Rx Only Sterile for Single
The Issue: Integra became aware through an adverse complaint trend
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Small Rickham -Style Reservoir Rx Only Sterile for Single
The Issue: Integra became aware through an adverse complaint trend
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RTC 25-C Inline Aerosol Tee Adapter. Intended to be used
The Issue: Some packages of the RTC 25-C may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Broncho Flexible Fiberscope
The Issue: KARL STORZ Endoscopy America, Inc. is recalling the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intubation Flexible Fiberscope
The Issue: KARL STORZ Endoscopy America, Inc. is recalling the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Advanced Energy Aquamantys3 Pump Generator
The Issue: The internal protection circuitry on the electrosurgical output
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable
The Issue: Select lots of SANDEL Weighted Safety Scalpels are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety
The Issue: Select lots of SANDEL Weighted Safety Scalpels are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety
The Issue: Select lots of SANDEL Weighted Safety Scalpels are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# Disposable Safety
The Issue: Select lots of SANDEL Weighted Safety Scalpels are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius 2008 Series Hemodialysis Machines: Models: 2008H
The Issue: 2008 Series Hemodialysis Machines complaints of saline bags
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety
The Issue: Select lots of SANDEL Weighted Safety Scalpels are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable
The Issue: Select lots of SANDEL Weighted Safety Scalpels are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety
The Issue: Select lots of SANDEL Weighted Safety Scalpels are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6
The Issue: As part of routine manufacturing process monitoring by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6
The Issue: As part of routine manufacturing process monitoring by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6
The Issue: As part of routine manufacturing process monitoring by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Assembly
The Issue: Reports of friction within certain instrument arms can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.