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 34321–34340 of 38,428 recalls
Recalled Item: Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs
The Issue: Reports of the infusion tubing disconnecting from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs
The Issue: Reports of the infusion tubing disconnecting from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs
The Issue: Reports of the infusion tubing disconnecting from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs
The Issue: Reports of the infusion tubing disconnecting from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm...
The Issue: This is an expansion of the June 2013
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm Height
The Issue: This is an expansion of the June 2013
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 9mm Height
The Issue: This is an expansion of the June 2013
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm...
The Issue: This is an expansion of the June 2013
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex
The Issue: Ultradent Products Inc. is recalling various lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc)
The Issue: During the current inspection of CMP Industries, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brainlab
The Issue: The "fluoro match registration" function of the Navigation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plan Parameters workspace within Eclipse Treatment Planning System Version 11
The Issue: An anomaly has been traced to a software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FreeStyle Blood Glucose Test Strips
The Issue: Certain lots of FreeStyle and FreeStyle Lite Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FreeStyle Lite Blood Glucose Test Strips
The Issue: Certain lots of FreeStyle and FreeStyle Lite Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP
The Issue: DePuy Orthopaedics, Inc. is issuing a voluntary device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP
The Issue: DePuy Orthopaedics, Inc. is issuing a voluntary device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP
The Issue: DePuy Orthopaedics, Inc. is issuing a voluntary device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5
The Issue: DePuy Orthopaedics, Inc. is issuing a voluntary device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5
The Issue: DePuy Orthopaedics, Inc. is issuing a voluntary device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7
The Issue: DePuy Orthopaedics, Inc. is issuing a voluntary device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.