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 20261–20280 of 38,428 recalls
Recalled Item: Abbott ARCHITECT Creatine Kinase
The Issue: The product has a stability issue which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott ARCHITECT Creatine Kinase
The Issue: The product has a stability issue which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sedecal NOVA FA DR System. for diagnostic radiography.
The Issue: A safety problem with installation and maintenance could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Retrograde Cardioplegia Cannula
The Issue: The device was built with the rigid insertion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon
The Issue: Catheter unable to maintain inflation pressure during treatment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: P.F.C. SIGMA Revision Knee System Distal Augment
The Issue: This unit may be missing the screw/collet Assembly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott ARCHITECT c16000 Processing Module
The Issue: There is a potential to generate incorrect results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott ARCHITECT c4000 Processing Module
The Issue: There is a potential to generate incorrect results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott ARCHITECT c8000 Processing Module
The Issue: There is a potential to generate incorrect results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon or Endure Ophthalmic Microscope Product Usage: Used for low
The Issue: for the optical head to detach from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multirall(TM) 200Liko Strap Gripper P/N 3136250 overhead lift for patient
The Issue: The products manufactured on 5/5/17 may be assembled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4.5 Fr x 40 cm single-lumen PICC Kit
The Issue: The products may contain the incorrect catheter. Kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 440 mm
The Issue: The set screw is not able to advance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 440 mm
The Issue: The set screw is not able to advance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 320 mm
The Issue: The set screw is not able to advance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5.5 Fr x 40 cm double-lumen PICC Kit
The Issue: The products may contain the incorrect catheter. Kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 440 mm
The Issue: The set screw is not able to advance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 460 mm
The Issue: The set screw is not able to advance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 460 mm
The Issue: The set screw is not able to advance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 360 mm
The Issue: The set screw is not able to advance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.