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 22861–22880 of 38,428 recalls
Recalled Item: Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box
The Issue: Several instances of a catheter caught in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box
The Issue: Several instances of a catheter caught in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Peripheral Diamondback 1.50 Solid OAD
The Issue: Cardiovascular Systems, Inc. (CSI) is removing the products
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Peripheral Diamondback 1.25 Solid OAD
The Issue: Cardiovascular Systems, Inc. (CSI) is removing the products
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew LEGION L-WEDGE
The Issue: The Legion Screw-on Wedge Size 4 contained 5MM
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 14-442000S Antegrade Femoral Nail Instrument Kit
The Issue: Fracture of the bolt connecting the insertion guide
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.
The Issue: Fracture of the bolt connecting the insertion guide
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa
The Issue: Fracture of the bolt connecting the insertion guide
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal
The Issue: for failure of the device safety interlock
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40)
The Issue: The hot stamp label on the bag incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm
The Issue: It was determined that the deflection length indicated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: i-STAT DE handheld data processing module for clinical use
The Issue: Issues resulting from upgrade to software version 2.8:
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OTTO BOCK Kenevo knee joints Model 3C60=ST
The Issue: Otto Bock Healthcare Products GmbH has identified a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Destination Guiding Sheath catheter introducer
The Issue: The tucking depth feature of this catheter introducer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OTTO BOCK Kenevo knee joints Model 3C60
The Issue: Otto Bock Healthcare Products GmbH has identified a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LifeVest Wearable Defibrillator Model 4000
The Issue: Incorrect service code for properly catching critical defects
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse
The Issue: Analysis of the difference between the actual device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proclaim DRG Implantable Pulse Generator Model 3664
The Issue: Analysis of the difference between the actual device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended
The Issue: During an examination images were displayed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite
The Issue: Analysis of the difference between the actual device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.