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 30721–30740 of 38,428 recalls
Recalled Item: Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main
The Issue: Stryker Instruments is voluntarily recalling the CBCII Wound
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1/4 in. Double Trocar with Wound Drain Curved Trocar with
The Issue: Stryker Instruments is voluntarily recalling the CBCII Wound
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3/16 in. Curved Trocar with Wound Drain Curved Trocar with
The Issue: Stryker Instruments is voluntarily recalling the CBCII Wound
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1/4 in. Round Drain with Trocar Curved Trocar with Wound
The Issue: Stryker Instruments is voluntarily recalling the CBCII Wound
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Iamin Moist Dressing and the Iamin Hydrating Gel: intended to
The Issue: The labeling for the Iamin family of medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator...
The Issue: Accessories to the GYC-1000 laser were missing Laser
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1:
The Issue: Accessories to the GYC-1000 laser were missing Laser
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dade Actin Activated Cephaloplastin Reagent
The Issue: Recovery for assayed controls are out of assigned
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Universal Charger Product Usage: The Stryker Universal Battery Charger is
The Issue: The Stryker Universal Battery Charger is not transmitting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.
The Issue: Device software treatment preset parameters for the XC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sentec
The Issue: SenTec is voluntarily replacing V-Sign Sensors 2 due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TIGERPAW System II
The Issue: Increase of field reports involving issues with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TIGERPAW System II
The Issue: Increase of field reports involving issues with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device...
The Issue: TruFreeze Console caused a higher rate of liquid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers...
The Issue: Customer reports that the ventilator display can freeze
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EC-5000 Excimer Laser Corneal Surgery System (EC-5000
The Issue: Multi-stage treatment option for the EC-5000 Operator's Manual
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number:
The Issue: The potential exists for the Oscillating Saw Attachment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sedecal SA Mobile Diagnost w DR x-ray system
The Issue: Due to a software defect, the system may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips DigitalDiagnost Release 4.0.3
The Issue: The system is designed to emit a beep
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Homocysteine test system - Homocysteine Reagent. 05385415190
The Issue: Customers complained about under-recovery of non-Roche controls and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.