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 25701–25720 of 38,428 recalls
Recalled Item: INBONE STEM
The Issue: The firm discovered a lack of adequate documentation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CPS CALCANEAL PLATE SML 54MM
The Issue: The firm discovered a lack of adequate documentation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVANS OPENING WEDGE PLATE 10MM
The Issue: The firm discovered a lack of adequate documentation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SWANSON TRAPEZIUM IMPLANT
The Issue: The firm discovered a lack of adequate documentation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dart Fire HEADED SCREW 4.0X 32MM
The Issue: The firm discovered a lack of adequate documentation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SWANSON FINGER JOINT #2
The Issue: The firm discovered a lack of adequate documentation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PREMIER EHEC and PREMIER EHEC Bulk.
The Issue: Internal testing has demonstrated that the indicated kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Performance-LOAD Ambulance Cot Fastener Stretcher
The Issue: Stryker Medical initiated a voluntary recall of Stryker
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LCS Complete Knee Revision System VVC Insert Product Usage: LCS
The Issue: DePuy Orthopaedics, Inc. is voluntarily recalling one lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROW OnControl Bone Marrow Biopsy System Tray
The Issue: Sterility: Due to a potential incomplete seal on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROW OnControl Bone Lesion Biopsy System Tray
The Issue: Sterility: Due to a potential incomplete seal on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OnControl Biopsy System Ported Needle Tray
The Issue: Sterility: Due to a potential incomplete seal on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray
The Issue: Sterility: Due to a potential incomplete seal on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROW OnControl Ported Aspiration System Tray
The Issue: Sterility: Due to a potential incomplete seal on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Hemotherm 400CE 115v
The Issue: The device may not maintain water flow or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase...
The Issue: Due to a customer experiencing complaints on bone
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
The Issue: The device defect associated with this recall may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDRAD Intego PET Infusion System - Pump Intended to deliver
The Issue: Bayer has determined that all current Source Administration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner
The Issue: Products were labeled with incorrect Global Trade Item
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alteon Neck Preserving Stem
The Issue: Products were labeled with incorrect Global Trade Item
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.