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 19921–19940 of 38,428 recalls
Recalled Item: Ambu Aura40 Standard
The Issue: Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C-flex 570C +19.0D Intraocular Lens Product Usage: C-flex IOLs are
The Issue: Firm become aware of reports of post-operative refractive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm
The Issue: HipLOC System Plate Barrel due to an undersized
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HipLOC Hip Fracture Fixation System-Hiploc System 140¿ Plate 38 mm
The Issue: HipLOC System Plate Barrel due to an undersized
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38
The Issue: HipLOC System Plate Barrel due to an undersized
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm
The Issue: HipLOC System Plate Barrel due to an undersized
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Extra corporeal circuit with bio-active surface.
The Issue: Affected products failed a sterilization test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ImplantDirect Legacy 3 Implant
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart Infant/Child SMART Pads Cartridge
The Issue: The recall is being initiated due to incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ColoCARE
The Issue: The positive control on some tests of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ColoCARE
The Issue: The positive control on some tests of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test
The Issue: Defect with the calibration button for lot 1808M
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affixus Hip Fracture Nail Right 125 11 mm x 340 mm
The Issue: There were complaints indicating that when the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affixus Hip Fracture Nail Right 130 11 mm x 340 mm
The Issue: There were complaints indicating that when the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affixus Hip Fracture Nail Right 125 13 mm x 400 mm
The Issue: There were complaints indicating that when the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affixus Hip Fracture Nail Left 125 13 mm x 260 mm
The Issue: There were complaints indicating that when the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affixus Hip Fracture Nail Right 125 11 mm x 440 mm
The Issue: There were complaints indicating that when the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affixus Hip Fracture Nail Right 125 11 mm x 460 mm
The Issue: There were complaints indicating that when the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affixus Hip Fracture Nail Right 125 13 mm x 180 mm
The Issue: There were complaints indicating that when the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affixus Hip Fracture Nail Left 130 11 mm x 360 mm
The Issue: There were complaints indicating that when the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.