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 15821–15840 of 38,428 recalls
Recalled Item: Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile
The Issue: Feeding tube plastic tethered closure cap may possibly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile
The Issue: Feeding tube plastic tethered closure cap may possibly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile
The Issue: Feeding tube plastic tethered closure cap may possibly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile
The Issue: Feeding tube plastic tethered closure cap may possibly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LabPro Data Management System
The Issue: A security-only update was released via remote diagnostics
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SnapLink
The Issue: The action is being taken due to an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection
The Issue: for the sterile barrier to be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SnapLink
The Issue: The action is being taken due to an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Getinge 46-Series Washer Disinfector Model # 46-4
The Issue: Due to a missing water intake for Deionized
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Getinge 46-Series Washer Disinfector Model # 46-4
The Issue: Due to a missing water intake for Deionized
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zenith Alpha Spiral-Z Endovascular Leg
The Issue: The firm has identified factors which contributed to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COHERENCE Oncologist
The Issue: A potential safety issue arises when an offset
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth
The Issue: The catheter locks for the lot may contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005
The Issue: Non-sterile product was shipped to customers. Product package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject 3mL Syringe with Hypodermic Safety Needle
The Issue: Non-sterile product was shipped to customers. Product package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558
The Issue: Non-sterile product was shipped to customers. Product package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject Bluntfill with Filter
The Issue: Non-sterile product was shipped to customers. Product package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: i-STAT CG4+ cartridge (blue)
The Issue: The I-STAT BLUE CHEM8+ and CG4+ cartridges are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: i-STAT CHEM8+ cartridges (blue)
The Issue: The I-STAT BLUE CHEM8+ and CG4+ cartridges are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Epidural Catheterization Kit with FlexTip Plus
The Issue: There is the potential for various failures with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.