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 3301–3320 of 38,428 recalls
Recalled Item: SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable
The Issue: Software issues were identified in application version 2.x
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF
The Issue: Custom convenience kits are being recall because the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Merlin PCS 3650 programmer Model 3330 The Merlin PCS
The Issue: Due to a programmer software anomaly, during finalizing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC 3D Fluoroscopic X-Ray System
The Issue: Due to manufacturing issue of insufficient sealing of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC Elite Fluoroscopic X-Ray System
The Issue: Due to manufacturing issue of insufficient sealing of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC 9900 Fluoroscopic X-Ray System
The Issue: Due to manufacturing issue of insufficient sealing of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC 9800 Fluoroscopic X-Ray System
The Issue: Due to manufacturing issue of insufficient sealing of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685....
The Issue: A software bug within the Gen 2 StatStrip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog...
The Issue: A software bug within the meter firmware leads
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683....
The Issue: A software bug within the meter firmware leads
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
The Issue: The following four issues are included: 1. Certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VACUETTE SAFELINK
The Issue: The VACUETTE SAFELINK Holder with male luer lock
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SUC-4300S
The Issue: Incomplete or partial pouch seals, which may result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
The Issue: Devices were identified as released after repair without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
The Issue: Devices were identified as released after repair without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Duravent Silicone Ventilation Tube. Model Number: 240075.
The Issue: that Duravent Silicone Ventilation Tubes may contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT
The Issue: Certain Medline kits were manufactured and distributed with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits labeled as: 1) Port Access Kit
The Issue: Certain Medline kits were manufactured and distributed with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT
The Issue: Certain Medline kits were manufactured and distributed with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tec 820 ISO Anesthesia Vaporizer
The Issue: Due to a manufacturing issue, certain Tec 6
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.