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 34781–34800 of 38,428 recalls
Recalled Item: GE Healthcare
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NC Sprinter
The Issue: Compliance chart included in lot 207002011 of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm
The Issue: CooperSurgical is recalling two lots of 900-863 because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tri-Nex Healing Abutment
The Issue: Southern Implants is recalling the Tri-Nex healing abutment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: pH 7.0 Buffer Solution Pint and Quart Bottles
The Issue: Mesa Laboratories, Inc. is recalling certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43
The Issue: 4 lots of Performa Cardiac Multipacks contain a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NX3 Try-In Gel. The product is used as a tooth shade resin material.
The Issue: Kerr Corporation is voluntarily recalling one lot of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access 2 Immunoassay System
The Issue: Beckman Coulter is recalling the Access 2 Immunoassay
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Solea 1.0 Laser Surgical instrument for use in general and
The Issue: Specific error condition could lead to unintended laser
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAQUET Getinge Group CARDIOHELP Base Unit .7999 .8012
The Issue: It has come to the attention of MAQUET
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Artis zee / zeego Angiography System is designed as
The Issue: There is a potential issue on running Artis
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica Ceiling Mount MSF-1 for use with M841 and M501
The Issue: The ceiling mount supplier encountered an event in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica Ceiling Mount MS-1F & MC-1F for use with the
The Issue: The ceiling mount supplier encountered an event in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ******InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm...
The Issue: Exactech is recalling the InteGrip Acetabular Augments due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Rotoprone therapy System is an advanced patient care system
The Issue: The lock pin can become stuck in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PedFuse Bone Probe
The Issue: Bone Probes used to create a pathway in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Harvest Graft Delivery System
The Issue: for leur connector to leak or have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: P21x/5-1 MHz transducer
The Issue: FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hospira RECEPTAL LINERS: 1L(1000mL)
The Issue: Hospira has become aware of customers using the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hospira RECEPTAL CANISTERS: 1L(1000mL)
The Issue: Hospira has become aware of customers using the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.