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 34821–34840 of 38,428 recalls
Recalled Item: Small Bone Innovations (SBi) rHead Radial Stem
The Issue: The recall was initiated due to an increased
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABX PENTRA Calcium CP Reagent
The Issue: HORIBA Medical is informing all PENTRA 200 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Selenia Full Field Digital Mammography System with software versions 5.0.x
The Issue: Software: When the Selenia upon meeting the hard
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Perkin Elmer 226 Sample Collection Device
The Issue: Some devices may be contaminated on the back
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: AVEA¿ Ventilator. All Models. The affected devices are
The Issue: CareFusion has identified a potential risk associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Calcium Arsenazo
The Issue: Calcium Arsenazo Reagent, reference CALA-0250, is recalled due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System
The Issue: Software malfunction may occur resulting in a certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm)
The Issue: The firm is issuing a voluntary recall due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cranial Access (CRAK) Kits
The Issue: Integra is recalling certain lots of Cranial Access
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (Siemens Rad Fluoro Uro Systems) Ysio
The Issue: A potential malfunction and hazard to patients exists
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia
The Issue: When using systems operating with software versions VD10A/G
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 1650 System Software: 1) V4.01
The Issue: Siemens Healthcare Diagnostics issued a Urgent Medical Device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 1200 System Software: 1) V2.00
The Issue: Siemens Healthcare Diagnostics issued a Urgent Medical Device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 1800 System Software V2.01. Performs assays for general and
The Issue: Siemens Healthcare Diagnostics issued a Urgent Medical Device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 2400 System Software V4.01. Performs assays for general and
The Issue: Siemens Healthcare Diagnostics issued a Urgent Medical Device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrightView XCT is a gamma camera for Single Photon Emission
The Issue: Philips received reports from the field that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blanketrol III
The Issue: During a label review it was discovered that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: King LT-D Oropharyngeal Airways The King LT-D is intended for
The Issue: Report that size 5 KLTD airways were packaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bright Embrace
The Issue: Upper limit for ambient temperature for use of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aquatec Ocean VIP
The Issue: The snap-on fixtures of the backrest cushion on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.