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 31861–31880 of 38,428 recalls
Recalled Item: Soft Contact Lens
The Issue: Portions of the lots may contain units with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mammomat Inspiration system: Product Usage: mammography exams
The Issue: It was determined that if the Mammomat Inspiration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The J700 Floor Mounted Tube Stand (FMTS) is intended to
The Issue: The welds on J700 tube stands may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Drill set long
The Issue: Drill set may contain incorrect drill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Turbo Troponin I For in vitro diagnostic use for the Recalled by Siemens...
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger
The Issue: breach of sterile barrier due to defective
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cooper Surgical CANNULA-CURETTE 12MM
The Issue: The product has been identified to contain an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Discovery MR950 MRI system
The Issue: The alignment lasers are missing the labels required
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radiomat M+ NIF 14 x 17
The Issue: Some material of the coating Type CXCPMV3 has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Dual Switch Valve is used for fluid drainage from
The Issue: Aesculap Inc. (AIC (USA)) initiated a recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Relief ACP Oral Care Gel intended to relieve discomfort from
The Issue: Product sold after April 1, 2014 were inadvertently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Titan Reverse Shoulder System right and left head cutting templates
The Issue: A single lot of left and a single
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200)
The Issue: MedTest DX Assayed Human Multi Sera Control Level
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JResultNet drivers using ASTM coding language. Calculator/data processing module
The Issue: Software issue resulting in the results of one
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROTROL P Control for ROTEM delta Thromboelastometry System
The Issue: Some of vials were found to be partially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diagnostic Imaging Tray (General Surgery convenience kit)
The Issue: According to the recall notice received from Hospira,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit)
The Issue: According to the recall notice received from Hospira,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)
The Issue: According to the recall notice received from Hospira,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nerve Block Tray (Nerve Block convenience kit)
The Issue: According to the recall notice received from Hospira,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.