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 7281–7300 of 38,428 recalls
Recalled Item: Conventional Knife Crescent 2.5mm
The Issue: One lot of Conventional Crescent Knife 2.5mm, 55
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multichem P
The Issue: Technopath Manufacturing Ltd. has identified an issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multichem S Plus
The Issue: Technopath Manufacturing Ltd. has identified an issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multichem IA Plus
The Issue: Technopath Manufacturing Ltd. has identified an issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics V60/V60 Plus Ventilator
The Issue: Power Management PCBAs may malfunction, causing a power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM
The Issue: Peripheral coil system detachable has a potential of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various Medical Products stored on pallets
The Issue: Various medical devices potentially exposed to rodent and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Tempus Pro Patient Monitor
The Issue: Full screen error message may occur on patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LFS Flat screen support arm systems without surgical lamp for
The Issue: The stopper block on the LFS bracket could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LFS Flat screen arm system with surgical lamp for Models Aurora series
The Issue: The stopper block on the LFS bracket could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cinchlock SS Knotless Anchor Inserter
The Issue: Expired Product distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MINISCAV (tm) Vacuum Pump
The Issue: Inadequate documentation of acceptance activity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smiths Medical Portex Bivona Pediatric Tracheostomy Tube
The Issue: The unit box is labeled with an incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: REVERSE PROSTHESIS SHOULDER SYSTEM
The Issue: Reverse shoulder prosthesis package that should contain 5mmx30
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMPOWR Acetabular System
The Issue: Knee insert and acetabular system parts were swapped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMPOWR 3D Knee Tibial Insert
The Issue: Knee insert and acetabular system parts were swapped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Apellis Injection Kit 29g Injection Needle -single use intended to
The Issue: 19-gauge x 1" inch filter needles showed appearances
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett Cuff Pressure Manager
The Issue: Inadequate internal fixation of the power inlet port
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used
The Issue: Handbook Revision (Rev13) a dilution step is indicated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
The Issue: Some catheter kits labeled as 23 cm implant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.