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 36841–36860 of 38,428 recalls
Recalled Item: Animas Vibe Insulin Infusion Pump and System. These products are
The Issue: Animas determined that keypad wear over time was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during
The Issue: The defect was with mis-engraving of the lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers
The Issue: When the operator for a wall stand view
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hoffman LRF Wire Bolt
The Issue: Two complaints have been filed where Hoffman LRF
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INTRABEAM Balloon Applicator Set
The Issue: A manufacturing defect has been identified which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quasar Power Pack contains a Baby Quasar and a Baby
The Issue: Quasar Bio-Tech is recalling their Baby Quasar, Baby
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baby Quasar (LAB-001-D
The Issue: Quasar Bio-Tech is recalling their Baby Quasar, Baby
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quasar MD is an infrared LED lamp that is labeled
The Issue: Quasar Bio-Tech is recalling their Baby Quasar, Baby
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that
The Issue: Re-usable video laryngoscope blades of the GlideScope GVL3,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INTRABEAM Balloon Applicator Set
The Issue: A manufacturing defect has been identified which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INTRABEAM Balloon Applicator Set
The Issue: A manufacturing defect has been identified which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioPlant
The Issue: The firm initiated the recall becaue disturbing the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20....
The Issue: When the MC-500 is turned on and coagulation
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. has become aware of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Medical Systems
The Issue: Software anomaly. Philips determined that the TumorLOC software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Medical Systems
The Issue: Software anomaly. Philips determined that the TumorLOC software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Medical Systems
The Issue: Software anomaly. Philips determined that the TumorLOC software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Medical Systems
The Issue: Software anomaly. Philips determined that the TumorLOC software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sekisui Diagnostics
The Issue: Spectrolyse PAI-1 activity assay, producing lower than expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Superstat Modified Collagen Hemostatic Sponge
The Issue: The recall was initiated because Superstat Corporation has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.