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 14581–14600 of 38,428 recalls
Recalled Item: M-Close Kit
The Issue: The plastic housing on the device may fracture
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System Model: Ultimax-i
The Issue: During a procedure, when images were acquired, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Calcaneus Plate
The Issue: The contract manufacturer of the calcaneus plate inadvertently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Calcaneus Plate
The Issue: The contract manufacturer of the calcaneus plate inadvertently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Calcaneus Plate
The Issue: The contract manufacturer of the calcaneus plate inadvertently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Calcaneus Plate
The Issue: The contract manufacturer of the calcaneus plate inadvertently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Calcaneus Plate
The Issue: The contract manufacturer of the calcaneus plate inadvertently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Calcaneus Plate
The Issue: The contract manufacturer of the calcaneus plate inadvertently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
The Issue: Kits failed sterility testing and showed evidence of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: APPX 0.75ml
The Issue: Identification of a potential manufacturing defect on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 126" (320 cm) 16.4 ml
The Issue: Identification of a potential manufacturing defect on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 7" (18 cm) Appx 0.29 ml
The Issue: Identification of a potential manufacturing defect on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 112" (284 cm) 60 Drop 150ml Burette Set (Clave
The Issue: Identification of a potential manufacturing defect on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 7 IN (18CM) APPX 0.26ml
The Issue: Identification of a potential manufacturing defect on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Appx 0.82 ml
The Issue: Identification of a potential manufacturing defect on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 83" (211 cm) Smallbore Ext Set w/Remv 8 Gang 4-Way
The Issue: Identification of a potential manufacturing defect on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 13 IN (33cm) APPX 0.96 ml
The Issue: Identification of a potential manufacturing defect on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 13 IN(33cm) APPX 1.0 ml
The Issue: Identification of a potential manufacturing defect on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 7" (18cm) Appx 0.31 ml
The Issue: Identification of a potential manufacturing defect on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6.5" (17 cm) Appx 0.35 ml
The Issue: Identification of a potential manufacturing defect on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.