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 5241–5260 of 38,428 recalls
Recalled Item: X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation
The Issue: A potential dose error exists for patients treated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Blueprint Software
The Issue: The software bug allows for case planning with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MyoSPECT System
The Issue: There is a potential issue regarding the service
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis(TM) Anesthesia Station 4000
The Issue: fluid ingress of anesthesia station or med
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Total Knee Arthroplasty (TKA) 2
The Issue: Application software intended to be deployed on Mako
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Total Knee Arthroplasty (TKA) 2
The Issue: Application software intended to be deployed on Mako
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Total Knee Arthroplasty (TKA) 2
The Issue: Application software intended to be deployed on Mako
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis" Anesthesia Station ES
The Issue: fluid ingress of anesthesia station or med
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis MedStation 4000 System
The Issue: fluid ingress of anesthesia station or med
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Total Knee Arthroplasty (TKA) 2
The Issue: Application software intended to be deployed on Mako
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Total Knee Arthroplasty (TKA) 2
The Issue: Application software intended to be deployed on Mako
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis MedStation ES
The Issue: fluid ingress of anesthesia station or med
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Total Knee Arthroplasty (TKA) 2
The Issue: Application software intended to be deployed on Mako
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower
The Issue: fluid ingress of anesthesia station or med
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal
The Issue: damage to the cartridge can result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis" MedStation ES 7-Drawer Auxiliary Tower
The Issue: fluid ingress of anesthesia station or med
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
The Issue: The firm identified that the measured patient leakage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Incisive CT - Computed Tomography X-Ray System intended to produce
The Issue: Metal mounting box on the rotating scanner on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Incisive CT - Computed Tomography X-Ray System intended to produce
The Issue: Metal mounting box on the rotating scanner on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: APTUS 2.8 TriLock Screw 22mm
The Issue: Screw is 16mm long instead of 22mm long
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.