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 36541–36560 of 38,428 recalls
Recalled Item: Becton
The Issue: In-vitro diagnostic reagents for microbiological testing may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sybron Endo Lightspeed: LSX Files
The Issue: The length markings on the Lightspeed LSX files
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Laboratories
The Issue: The Architect 25-OH Vitamin D assay has the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device...
The Issue: Toshiba Medical Systems has received reports of startup
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD MAX PCR Cartridges Catalog #437519
The Issue: Cartridges are not sealing properly during PCR testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated...
The Issue: During electrical recertification testing it was found that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning
The Issue: Depending on the system configuration, a software error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BBL(TM) Fildes Enrichment
The Issue: Enrichment media intended to enhance the cultivation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R)...
The Issue: Firm has confirmed higher imprecision with the recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flowtron Trio DVT Pump
The Issue: The Flowtron Trio DVT Pump has been marketed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum A+ Hyperbaric Single Channel Infusion Pumps
The Issue: The door roller assembly on the Plum A+/A+3
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum A+3 Triple Channel Infusion Pumps
The Issue: The door roller assembly on the Plum A+/A+3
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum A+ Single Channel Infusion Pumps
The Issue: The door roller assembly on the Plum A+/A+3
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Emit(R) tox(TM) Serum Calibrators
The Issue: Incorrect expiration date was assigned to the D1
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liko Standard Slingbar 450. The Standard Slingbar 450 is a
The Issue: Liko/Hill-Rom has received reports from facilities which indicate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Outlook ES pump is intended for use with B. Braun
The Issue: B. Braun Medical Inc. is informing our customers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canon Full Auto RK-F2
The Issue: Canon Inc. had received 17 claims from our
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs Smart Disclosure System
The Issue: Displaying or printing of an incorrect waveform for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Companion External Battery
The Issue: Syncardia Systems is recalling the Companion External Batteries
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott m2000sp Instrument
The Issue: An issue with the m2000sp Instrument software has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.