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 13481–13500 of 38,428 recalls
Recalled Item: Harmony System (aka Harmony RS)/ Medical Device Data System
The Issue: Harmony RS integrations with Topcon equipment, TRC NW-400
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard
The Issue: CME America BodyGuard 323 Infusion Pumps (recalled by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laerdal Compact Suction Unit (LCSU 4)
The Issue: Component failures may cause the unit to lose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AnshLabs - SARS-CoV2 IgM ELISA (u-Capture)
The Issue: Labeling update; To reduce the risk of false
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System
The Issue: GE Healthcare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System
The Issue: GE Healthcare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid...
The Issue: Bottles Missing Product Label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A calculator/data processing module for clinical use is an electronic
The Issue: A software error results in the unintentional removal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXOGEN Ultrasound Coupling Gel
The Issue: Product may contain white particulates that are microbial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KWIK-STI(TM)
The Issue: The expiration date on the label of one
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KWIK-STIK 2 Pack
The Issue: Contamination with S. epidermidis
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips EPIQ Diagnostic Ultrasound System
The Issue: The manufacturer discovered an issue associated with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: X1
The Issue: Neonatal Valves were manufactured with a ventricular catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: X1
The Issue: Neonatal Valves were manufactured with a ventricular catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: X1
The Issue: Neonatal Valves were manufactured with a ventricular catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Disposable Humidification Flask
The Issue: A small percentage of the Disposable Humidification Flasks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WAHL 4212 HEATED MASSAGER
The Issue: The connection between the massager and heat element
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF
The Issue: The catheter may become susceptible to distal tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Penumbra JET 7 Reperfusion Catheter The Penumbra JET
The Issue: The catheter may become susceptible to distal tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX
The Issue: The catheter may become susceptible to distal tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.