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 11321–11340 of 38,428 recalls
Recalled Item: Zenition 50
The Issue: Firm discovered that the wireless foot switch can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zenition 70
The Issue: Firm discovered that the wireless foot switch can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Michels Transport Medium
The Issue: Product stored incorrectly in temperature controlled setting instead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HARDY DIAGNOSTICS CatScreen
The Issue: Product stored incorrectly in temperature controlled setting instead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Celltrion DiaTrust COVID-19 Ag Rapid Test
The Issue: The European version of the DiaTrust COVID-19 Ag
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Premier Rotaclone
The Issue: Product stored incorrectly in temperature controlled setting instead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic
The Issue: ¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemashield Gold Knitted Bifurcated
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regard
The Issue: Kits lacks rubber latex warning label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls
The Issue: Affected product was shipped from the warehouse at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model:
The Issue: Due to: 1) Manufacturing issue that result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: activforce 2 package labeling: Model: Activ5-M R 201-200563
The Issue: Due to: 1) Manufacturing issue that result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medichoice Infant Heel Warmer
The Issue: After the device was cleared by the FDA,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infant Heel Warmers w/strap
The Issue: After the device was cleared by the FDA,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heel Snuggler
The Issue: After the device was cleared by the FDA,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Infant Heel Warmer
The Issue: After the device was cleared by the FDA,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proteus 235
The Issue: Proton Therapy System (PTS) software can be started
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infa-Therm Transport Mattress
The Issue: After the device was cleared by the FDA,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.