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 19261–19280 of 38,428 recalls
Recalled Item: ImplantDirect InterActive Precision IO Scan Adapter
The Issue: The peek part was loose on the titanium
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated...
The Issue: Supplier had changed its resin sub-suppliers three (3)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maximum Variable Pitch Compression Screw Caddy
The Issue: There is a potential for silicone shedding during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maximum Variable Pitch Compression Tray Base
The Issue: There is a potential for silicone shedding during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open...
The Issue: Supplier had changed its resin sub-suppliers three (3)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open...
The Issue: Supplier had changed its resin sub-suppliers three (3)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant....
The Issue: The surgical technique is being updated to caution
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical
The Issue: Reports of pressure tubing separation between the sampling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical
The Issue: Reports of pressure tubing separation between the sampling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical
The Issue: Reports of pressure tubing separation between the sampling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RESERVOIR "Y" ADAPTER
The Issue: Medtronic discovered that certain Y-connectors included in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and
The Issue: Medtronic discovered that certain Y-connectors included in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laparotomy Sponge
The Issue: compromise of product sterility due to breach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endoform Dermal Template 2x2
The Issue: for pouch seal failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endoform Dermal Template 2x2
The Issue: for pouch seal failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endoform Dermal Template 4x5
The Issue: for pouch seal failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProtectIV¿ Plus Safety IV Catheter
The Issue: Certain lots of the Model 306701 ProtectIV¿ Plus
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reliance LITe Nerve Hook Bayoneted
The Issue: Instead of having a spherical diameter, the probe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartStart MRx
The Issue: Affected lithium-ion batteries may contain a defective component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Xi Surgical System
The Issue: Due to a manufacturing variation in the arm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.