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 28801–28820 of 38,428 recalls
Recalled Item: 0 deg
The Issue: This correction to the da Vinci Xi I&A
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Granada Biphasic Broth The product is a selective medium for
The Issue: FDA has determined that the product requires 510(k)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)
The Issue: Mitek identified that on VAPR Tripolar 90 Degree
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cournand Modified 2-PC 19G
The Issue: The Guidewire Introducer Needle (0910-192-000) was shipped after
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades
The Issue: Product is incorrectly labeled. The blade configuration in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of
The Issue: "The public reason for the recall is that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades
The Issue: Product is incorrectly labeled. The blade configuration in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades
The Issue: Product is incorrectly labeled. The blade configuration in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the
The Issue: The firm discovered that information printed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical
The Issue: Manufacturing error within the Torque Handle may prohibit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number:...
The Issue: During routine monitoring of complaints, BSC noted that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10
The Issue: During routine monitoring of complaints, BSC noted that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Tiny Toes
The Issue: Heel warmers may cause first and second degree
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization
The Issue: These screws have a single lead (instead of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntellaTip MiFi XP Asymmetric (N4) Curve
The Issue: During routine monitoring of complaints, BSC noted that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS
The Issue: During routine monitoring of complaints, BSC noted that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery Set
The Issue: for leaking between the purple ENFit connector
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and
The Issue: Cook Medical initiated a voluntary recall of specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOVES System
The Issue: Batteries found unresponsive after storage, not recognized by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOVES System Lithium Polymer Batteries The MOVES System is a
The Issue: Batteries found unresponsive after storage, not recognized by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.