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 36821–36840 of 38,428 recalls
Recalled Item: Access Immunoassay System
The Issue: It has been determined that, in some cases,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic
The Issue: The items in this lot are missing the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSS Reamer Sleeve KNEE REAMER SLEEVE 13.0 thru 20.0
The Issue: Biomet has initiated this action following an investigation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobas 8000 Modular Analyzer Series
The Issue: On cobas c 701 and cobas c 702
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSS Reamer Sleeve KNEE REAMER SLEEVE 8.0 THRU 12.5
The Issue: Biomet has initiated this action following an investigation
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: This notice is being provided in follow up
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Posey Biothane Restraint Cuffs
The Issue: The firm voluntarily recalled Biothane Restraint Cuffs, Catalog
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liko Overhead Rail System
The Issue: Liko/Hill-Rom to date has received two reports from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cooper Surgical RUMI Arch
The Issue: Excessive pressure exerted on the uterine tip when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cooper Surgical Advincula Arch
The Issue: Excessive pressure exerted on the uterine tip when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intraosseous Fixation System (IFS) 1.7 mm
The Issue: The firm was notified by a customer that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Digital Diagnost Stationary radiographic system
The Issue: When the operator for a wall stand view
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system
The Issue: With Digital Diagnost R2.0.2 a mirrored "R in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis
The Issue: Affected lots of Cordis ExoSeal (TM) VCD have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support
The Issue: During a recent review of documentation Anspach determined
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter AU5800 Clinical Chemistry Analyzer
The Issue: Beckman Coulter is recalling the AU8500 Clinical Chemistry
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that
The Issue: The volume control knob on some Plum A+
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet
The Issue: The volume control knob on some Plum A+
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software
The Issue: The volume control knob on some Plum A+
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium
The Issue: Battery may over-heat during charging and smoke
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.