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 12481–12500 of 38,428 recalls
Recalled Item: Probe Cover
The Issue: No 510k for the product to be used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover
The Issue: No 510k for the product to be used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Probe Cover
The Issue: No 510k for the product to be used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Probe Cover
The Issue: No 510k for the product to be used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Probe Cover 6" x 48" regular PE w/ 2 Elastic
The Issue: No 510k for the product to be used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Probe Cover
The Issue: No 510k for the product to be used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transducer Cover 18x147cm
The Issue: No 510k for the product to be used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover
The Issue: No 510k for the product to be used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29
The Issue: No 510k for the product to be used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6" x 96" Elastic Poly Probe Cover
The Issue: No 510k for the product to be used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transducer Cover 15x147cm
The Issue: No 510k for the product to be used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Probe Cover
The Issue: No 510k for the product to be used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6" x 48" Elastic Poly Probe Cover
The Issue: No 510k for the product to be used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Probe Cover 6" x 96" regular PE w/ 3 Elastic
The Issue: No 510k for the product to be used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22
The Issue: No 510k for the product to be used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Adult-Pediatric Electrostatic Filter HME
The Issue: The company was notified by their supplier of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mechanical Filter with Connector Small
The Issue: The company was notified by their supplier of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic HY10L28R3
The Issue: Specific lots may have been manufactured with insufficient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic CB10Y89R10
The Issue: Specific lots may have been manufactured with insufficient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic CB10W64R1
The Issue: Specific lots may have been manufactured with insufficient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.