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 31301–31320 of 38,428 recalls
Recalled Item: RAPIDLab 1245 System
The Issue: Neonatal bilirubin (nBili) parameter may have increased variability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RAPIDPoint 405 Blood Gas Analyzer
The Issue: Neonatal bilirubin (nBili) parameter may have increased variability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ebb Complete Tamponade System
The Issue: for a balloon leak in all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Hand-held Barcode Scanner
The Issue: In combination with the Batch Programming option (only)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter
The Issue: Self-Righting Luer Tip Caps were manufactured and shipped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG)
The Issue: Reports of customers falling from the Inversion Table
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tyvek Pouch/Roll with STERRAD Chemical Indicator
The Issue: Advanced Sterilization Products (ASP) is recalling the Tyvek
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartStart MRx monitor/defibrillator Models M3535A
The Issue: MRx monitor/defibrillator could reboot at an indeterminate time,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FAR-Infrared Heat Home Sauna
The Issue: Product distributed without 510(k) approval
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portable FAR Infrared Sauna Indications including
The Issue: Product distributed without 510(k) approval
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FAR-Infrared Heat Home Sauna
The Issue: Product distributed without 510(k) approval
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI)....
The Issue: This recall has been initiated because use of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lubricated Intubating Stylet 6FR that is inserted into an endotracheal
The Issue: A small piece of the stylet sheath has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test
The Issue: The firm is recalling three batches (FP14A09, FP14A10,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan absorbent foam tipped applicator
The Issue: Shaft breaks so that adequate patient specimen sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flyte Togas are components of the Stryker Flyte System and
The Issue: A single lot (11121171) of Flyte Toga Peel-away
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses
The Issue: One unit from a demo lot of POWERFLEX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips IntelliVue Information Center iX (release A.00
The Issue: Sp02 and/or Non Invasive Blood Pressure (NBP) alarms
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx
The Issue: An issue was identified with the mAs accuracy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx
The Issue: An issue was identified with the mAs accuracy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.