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 31021–31040 of 38,428 recalls
Recalled Item: Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal
The Issue: for weld disassociation of the cross pin,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Autostainer Link 48 (AS480)
The Issue: A false negative result affecting the diagnosis may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device Exchange PT WIRE 300
The Issue: EXP did not register as a medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A
The Issue: EXP did not register as a medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device Exchange -Suction Coagulator
The Issue: EXP did not register as a medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER
The Issue: EXP did not register as a medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device Exchange SECURESTRAP 5mm Absorbable Strap Fixation Device
The Issue: EXP did not register as a medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device Exchange Wire (sternotomy wire)
The Issue: EXP did not register as a medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device Exchange Round Diamond Bur Extra Coarse
The Issue: EXP did not register as a medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device Exchange - Mayfield Disposable Skull Pin
The Issue: EXP did not register as a medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device Exchange Insufflation Needle
The Issue: EXP did not register as a medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device Exchange - Endo Catch 10mm
The Issue: EXP did not register as a medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device Exchange 3.5mm Threaded Cerclage Pin
The Issue: EXP did not register as a medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device Exchange 10x40 Airway Stent System
The Issue: EXP did not register as a medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device Exchange TAUT Intraducer Peritoneal Catheter 2mm x 1.6mm x 7.6cm
The Issue: EXP did not register as a medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device Exchange 10MM VASCULAR
The Issue: EXP did not register as a medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire
The Issue: EXP did not register as a medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device Exchange - Auto Suture Endo Universal 65¿¿ 4mm
The Issue: EXP did not register as a medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device Exchange Angio-Seal VIP Platform/Vascular Closure Device 6F
The Issue: EXP did not register as a medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device Exchange Round Fluted Bur Soft Touch
The Issue: EXP did not register as a medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.