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 33341–33360 of 38,428 recalls
Recalled Item: Philips/Children's Medical Ventures Smart Monitor 2 Professional Series...
The Issue: The battery pack wire harness is improperly assembled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Convatec Flexi Seal Control Fecal Management System Rx Only REF
The Issue: Convatec Inc. is recalling Flexi-seal FMS Control Kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes ProDisc-C 2.0mm Milling Bit
The Issue: Certain lots of the ProDisc-C 2.0mm Milling Bits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Temporary Pacemaker
The Issue: Events related to a pacing rate outside of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp
The Issue: Connection issues between the PD transfer set catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Express Dry Seal Chest Drain ATS Blood Recovery
The Issue: Product that was previously recalled because the Chest
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems...
The Issue: Greatbatch identified that the documentation does not support
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oasis Coil Extension Cable used with Hitachi Oasis MRI System
The Issue: The firm received a complaint stating the Coil
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VersaCell X3 Solution and VersaCell X3 Expansion Pack
The Issue: The keyboard and monitor may not be properly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation software version 4.0.3.4 RayStation is a software system designed
The Issue: This notice concerns a problem with the computation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue)
The Issue: Serum albumin component monomer failed to meet internally
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAMMOMAT Inspiration. Intended for mammography exams
The Issue: There is a potential and possible hazard to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revision K Actuator Test Boards sold as replacement parts for
The Issue: 2008-Series Hemodialysis Machines with Revision K Actuator Test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards
The Issue: 2008-Series Hemodialysis Machines with Revision K Actuator Test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Amia Automated PD systems are used in the treatment
The Issue: System error 01779 is produced when the battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRAPE 9732722 TUBE STERILE O-ARM 20PK
The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TUMOR RES. PACK 9733553 AxiEM S.M.
The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KIT
The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ENT PRGM 9734636 ADD FUSION NAV AxiEM
The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.