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 30741–30760 of 38,428 recalls
Recalled Item: ADVIA Chemistry Lipase Reagent
The Issue: Siemens internal investigation confirmed that current contamination avoidance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard ConQuest PTA Balloon Dilatation Catheter
The Issue: Bard Peripheral Vascular is recalling the Bard ConQuest
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
The Issue: One lot of BD CD123 PE (ASR) has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems
The Issue: Medtronic is conducting a voluntary recall of all
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8
The Issue: Edwards Lifesciences is recalling Fem-Flex II Pediatric Femoral
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smiths Medical
The Issue: The Auxiliary Serial Input/ Output Modes on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT
The Issue: Deterioration in performance of the Liquid Stable (LS)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Viking M
The Issue: Complaints (including one reported death) allegedly of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carter-Thomason II Port Closure System
The Issue: The pad printing around the suture entry holes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SMARTABLATE RF Generator System
The Issue: Biosense Webster is recalling the SMARTABLATE Generator System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Insorb Subcuticular Skin Stapler. INSORB staples are made from an
The Issue: A previous Turkish distributor over-labeled a portion of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q/ Q zen systems
The Issue: issue with the Artis Q/ Q zen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total
The Issue: Complaints of difficulties to attach the Anatomical Shoulder
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Magellan Robotic System
The Issue: Based on investigation of two complaint incidents, all
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LOW PROFILE NON-LOCK SCREW
The Issue: A Biomet investigation found that the Low Profile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Catheter / Cholangiogram Catheter 9100 Series.
The Issue: Catheters were not sealed before sterilization. and was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Head Holder shipped with Ingenuity Core Computed Tomography X-ray Systems.
The Issue: A head holder released for use with other
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems
The Issue: A head holder released for use with other
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray
The Issue: A head holder released for use with other
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CD99 Catalog number PM008 AA
The Issue: A drop in staining intensity over time has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.