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 5261–5280 of 38,428 recalls
Recalled Item: Arial mobile application
The Issue: The Arial Mobile Application utilizing Apple iOS 17.4
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FDR Visionary Suite - Intended to generate digital or conventional
The Issue: Bolts on the CH-200 tube may rupture due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Noblus AC Adapter used with the Noblus Ultrasound Imaging System
The Issue: AC adapters of Noblus can heat up, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are
The Issue: Due to incorrect milled titanium abutment being packaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica HistoCore PEGASUS Tissue Processor
The Issue: Poorly processed and/or damaged biopsy tissue specimens on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE HealthCare CRITIKON ONE-CUF blood pressure cuffs
The Issue: Use of the blood pressure cuffs could result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit...
The Issue: An increase in claims related to leakage of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit...
The Issue: An increase in claims related to leakage of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with
The Issue: Free T3 Calibrators used with T3 Reagent Packs
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spectrum IQ Infusion pump
The Issue: There is a potential for cracks on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the
The Issue: T3 Reagent Packs used with Free T3 Calibrators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedural kits labeled as: 1) ALL DOC EYE PACK
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience kits labeled as: ADMIT KIT PILLOW BOX
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience kits
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience kits labeled as: 1) CYSTO PACK
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience kits
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience kits labeled as: 1) ADMIT KIT
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience kits labeled as: 1) CENTRAL LINE CDS
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.