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 34121–34140 of 38,428 recalls
Recalled Item: Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical
The Issue: Some carbide cutting burr fractured during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part #
The Issue: Some carbide cutting burr fractured during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball
The Issue: Some carbide cutting burr fractured during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Artis zee Ceiling Systems. Angiographic x-ray system.
The Issue: During the lifetime of Artis zee Ceiling systems,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERRAD 100S Sterilization System
The Issue: Advanced Sterilization Products (ASP) is recalling the STERRAD
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERRAD NX Sterilization System
The Issue: Advanced Sterilization Products (ASP) is recalling the STERRAD
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERRAD 50 Sterilization System
The Issue: Advanced Sterilization Products (ASP) is recalling the STERRAD
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 840 ventilator systems software part number 4-070212-85
The Issue: Covidien is conducting a voluntary field corrective action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CODMAN CERTAS Programmable Valves
The Issue: Ensuring all customers have the tools to assist
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally
The Issue: Internal testing of two lots of the AccuFlo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SuperElastic Regular force NiTi lower or upper Natural arches. 0.14
The Issue: Labeling issue: Product labeled as "Upper" may contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SuperElastic Regular force NiTi lower or upper Natural arches. 0.16
The Issue: Labeling issue: Product labeled as "Upper" may contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: King Systems KLTSD414 Quantity
The Issue: KLTD214 airways found inside KLTSD414 packages. The KLTSD414
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System
The Issue: Sterility of medical devices intended for use in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Precision 500D
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Upgrade Kit
The Issue: Medical device adjustment knob may be loose and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stand-Alone Resuscitation
The Issue: Medical device adjustment knob may be loose and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stand-Alone Resuscitation Unit
The Issue: Medical device adjustment knob may be loose and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Giraffe¿ Infant Warmers
The Issue: Medical device adjustment knob may be loose and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.