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 33941–33960 of 38,428 recalls
Recalled Item: Medtronic Select 3D Arterial Cannulae. Vented
The Issue: Medtronic is recalling all models of its Select
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Select CAP Arterial Cannulae. Vented
The Issue: Medtronic is recalling all models of its Select
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SCC SA HIS version 4.0.7.0 when used with SoftMic version
The Issue: When an isolate is resulted without a SNOMED
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168
The Issue: Customers were unable to calibrate, or use previously
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gelzone Shoulder Sleeve
The Issue: Implantech initiated the voluntary recall of Gelzone Shoulder
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the
The Issue: Unapproved material used by vendor in subset of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
The Issue: Certain Silicone TECNIS IOLs may be labeled with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers
The Issue: patient data mixup. Improper error handling could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes
The Issue: Certain modules containing the Synthes Small Notch Titanium
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CSI
The Issue: Cardio vascular Systems Inc. has initiated a recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Matrix Mandible Short Threaded Drill Guide intended for oral
The Issue: One lot of Matrix Mandible Short Threaded Drill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes 3.2 mm Guide Wire 400mm. Used for guiding the
The Issue: Synthes 3.2 mm Guide Wire 400mm included an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum XL
The Issue: There is the potential for the door roller
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum XL3 Multi line Infusion System
The Issue: There is the potential for the door roller
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LifeCare 5000 Pump (Plum 1.6) infusion pump
The Issue: There is the potential for the door roller
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RetCam 3
The Issue: Software anomaly for RetCam 3, RetCam Shuttle and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Kodak 2100 Intraoral X-Ray System
The Issue: Carestream received problem reports relating to apparent early
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Kodak 2200 Intraoral X-Ray System
The Issue: Carestream received problem reports relating to apparent early
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency...
The Issue: NovaSure Radiofrequency Control Units may not meet a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is
The Issue: HeartStart XL+ battery charge time to 100% capacity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.