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 34461–34480 of 38,428 recalls
Recalled Item: MAS Urinalysis Control Level 1
The Issue: Via one (1) consumer complaint and in-house testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: e.cam line of gamma camera systems Used to detect or
The Issue: Reports of loose bolts in the detector support
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Symbia E is a multi-purpose SPECT system ideal for hospitals
The Issue: Reports of loose bolts in the detector support
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0
The Issue: Promotional materials for non-medical water filtration products were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue
The Issue: Promotional materials for non-medical water filtration products were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Disposable
The Issue: Integra LifeSciences Corporation is recalling certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1) Nephros SafeShower FH - 15 filters per box
The Issue: Promotional materials for non-medical water filtration products were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion Sterile # 84 Rubber Bands Reorder EB84
The Issue: Package labeling indicates both "latex free" and "contains
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc.
The Issue: Abbott Point of Care Inc (APOC) has determined
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vascu Guard
The Issue: Synovis, a subsidiary of Baxter International Inc., is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dura Guard
The Issue: Synovis, a subsidiary of Baxter International Inc., is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TruSystem Surgical Table (TS7000) Leg Section One Part Light
The Issue: The coupler point (hood) of the Leg Section
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Titan 3T MRI System
The Issue: Toshiba America Medical Systems, Inc. is recalling due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: *** 1) List number 126970465 labeled in part: 12697-65 LifeShield
The Issue: Several lots of the LifeShield Latex-Free HEMA Y-Type
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Civco Belly Board
The Issue: Scales adhered to the product may be misaligned
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Civco Belly Board MRI
The Issue: Scales adhered to the product may be misaligned
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
The Issue: Ortho Clinical Diagnostics issued a Product Correction Notification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1) Accolade II 127 Neck Angle Hip Stem
The Issue: Stryker received a report from the field indicating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Security (TM) Enclosed Carpal Tunnel System Blade (
The Issue: Security Blades were manufactured oversized and potentially won't
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of
The Issue: There is a software synchronization issue with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.