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 15801–15820 of 38,428 recalls
Recalled Item: FilmArray BCID Panel
The Issue: There is an increased risk of false positive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr.
The Issue: An issue with the DL900 and DL950 Series
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr.
The Issue: An issue with the DL900 and DL950 Series
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ellipse
The Issue: Past updates to programmers and transmitters may lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sysmex CV-11 Sample Unit
The Issue: When excessive amounts of urine spills on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Columbus R/PS TIB.PLATEAU Cemented
The Issue: Low Density Polyethylene (LDPE) particles may be present
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COLUMBUS CRA/PSA TIB.PLAT.CEMENTED
The Issue: Low Density Polyethylene (LDPE) particles may be present
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COLUMBUS CR/PS TIB.PLAT.PLASMAPORE
The Issue: Low Density Polyethylene (LDPE) particles may be present
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AS COLUMBUS CR/PS TIB.PLAT.CEMENTED
The Issue: Low Density Polyethylene (LDPE) particles may be present
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COLUMBUS REV F TIBIA OFFSET CEMENTED
The Issue: Low Density Polyethylene (LDPE) particles may be present
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PTS Detect Cotinine
The Issue: The firm is removing the product from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline ROBOTIC-LF Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
The Issue: The sterile pack inside the Complete Delivery System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Selenia Dimensions Mammography System
The Issue: The recalling firm has received reports from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline HOI LUMBAR Lot 20AKA895 Expiration 2021-05-31 1
The Issue: The sterile pack inside the Complete Delivery System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fentanyl Reagent Kit
The Issue: Labeled for diagnostic use and sold to clinical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlipCutter III Drill
The Issue: There is potential for the blister tray to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Econocare Plus Overlay Item: 1025EC. Intended to aid in the
The Issue: Due to a nonconformance of product contamination (human
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile
The Issue: Feeding tube plastic tethered closure cap may possibly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile
The Issue: Feeding tube plastic tethered closure cap may possibly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile
The Issue: Feeding tube plastic tethered closure cap may possibly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.