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 4641–4660 of 38,428 recalls
Recalled Item: FoundationOne Companion Diagnostic (F1CDx)
The Issue: Two (2) reports were sent to customers with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRANIOTOMY PACK
The Issue: A non-sterile Mastisol component, which was not labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANESTHESIA TURNOVER KIT
The Issue: A non-sterile Mastisol component, which was not labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KIT PEDI CRANI LAMI
The Issue: A non-sterile Mastisol component, which was not labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANESTHESIA TURNOVER KIT
The Issue: A non-sterile Mastisol component, which was not labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOFT-VU KUMPE 5F X 40CM -Used for patients in need
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOFT-VU KUMPE 5F X 65CM -Used for patients in need
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count
The Issue: BD Nano 2nd Gen Pen Needle was shipped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Handset with Communicator
The Issue: A subset of the handsets within the kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Afinion 2 Analyzer
The Issue: Five Afinion 2 (AF2) Analyzer were incorrectly market
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regard Kit containing the Microtek decanter
The Issue: Decanters may have pin holes and tears in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an
The Issue: for the backcheck valve to malfunction, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infusomat UNIV. 15 DROP PUMP SET
The Issue: for the backcheck valve to malfunction, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infusomat 60DROP METRISET PUMP SET
The Issue: for the backcheck valve to malfunction, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infusomat UNIV. 60 DROP PUMP SET
The Issue: for the backcheck valve to malfunction, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infusomat UNIV. 15 DR PUMP SET
The Issue: for the backcheck valve to malfunction, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infusomat SPACE PUMP IV SET
The Issue: for the backcheck valve to malfunction, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE
The Issue: for the backcheck valve to malfunction, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infusomat SPACE PUMP IV SET
The Issue: for the backcheck valve to malfunction, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infusomat 60DROP METRISET PUMP
The Issue: for the backcheck valve to malfunction, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.