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 38241–38260 of 38,428 recalls
Recalled Item: 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS
The Issue: Surgical technique instructions for the Versys and Slotted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral
The Issue: Surgical technique instructions for the Versys and Slotted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys
The Issue: Surgical technique instructions for the Versys and Slotted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: . 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys
The Issue: Surgical technique instructions for the Versys and Slotted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sunquest Laboratory LabAccess Results Workstation (LARS)
The Issue: The recall was initiated because Sunquest has confirmed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0
The Issue: In January 2010, Medtronic issued a recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0
The Issue: In January 2010, Medtronic issued a recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0
The Issue: In January 2010, Medtronic issued a recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ISE Electrolyte reagent (for Synchron LX Systems and UniCel
The Issue: Beckman Coulter is recalling the Synchron Systems LX20/UniCel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kimberly-Clark Patient Warming System - Model 1000 Control Unit The
The Issue: Error 85 alarm on the Model 1000 Control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: G7 HPLC. Used as an aid in the detection and
The Issue: The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA
The Issue: There is an issue with the DPM 6
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polar Dressing
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boule Con Diff US Tri Pack
The Issue: Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic
The Issue: Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TD-Synergy. Laboratory Information System.
The Issue: Technidata has discovered that using the F8 key
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xoran Minicat00158
The Issue: The MiniCAT CT Scanners subject to this notification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xoran Minicat00202
The Issue: The MiniCAT CT Scanners subject to this notification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xoran MiniCAT CT Scanner
The Issue: A description of the defect in the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xoran MiniCAT00202
The Issue: The MiniCAT CT Scanners subject to this notification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.