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 32761–32780 of 38,428 recalls
Recalled Item: Boston Scientific ENDOTAK RELIANCE¿ SG
The Issue: A review of manufacturing test records for Boston
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs Healthcare Ultraview SL Multigas Module
The Issue: With this software version, the Minimum Alveolar Concentration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEMINI TF PET/CT16: 882470
The Issue: When beginning a procedure to start the gantry
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C-Series High Energy Linear Accelerator - Models: Novalis Tx
The Issue: Trend in reports of unexpected decrease in beam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Syngo RT Therapist and Syngo RT Oncologist intended use
The Issue: Siemens became aware of a potential issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap with Povidone-Iodine Solution
The Issue: Inadequate iodine and packaging related defects
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo¿ Advanced Perfusion System 1 220/240V AC
The Issue: An evaluation of the APS1 Operator Manual found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartSite Low Sorbing Infusion Set
The Issue: CareFusion is recalling the SmartSite Low Sorbing Infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo¿ Advanced Perfusion System 1 100/120V AC
The Issue: An evaluation of the APS1 Operator Manual found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic MiniMed Implantable Insulin Pump
The Issue: Medtronic MiniMed is recalling the Implantable Insulin Pump
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for
The Issue: Image taken by AFC-330 has a white spot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Paragon Laboratory Management
The Issue: For Paragon Laboratory Management 12.1 and 12.1.1 releases,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS
The Issue: Aesculap Inc. (AIC (USA)) has initiated a voluntary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: Partial loss of monitoring with the CARESCAPE Monitor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Titan T 5K Motor Product Usage: Low-speed motor is used
The Issue: The housing of 5K motor was laser marked
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction
The Issue: Manufacturing variation in the grip assembly of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 3.0T
The Issue: For some identified Ingenia systems shipped between December
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 3.0T R5
The Issue: For some identified Ingenia systems shipped between December
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 1.5T
The Issue: For some identified Ingenia systems shipped between December
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 1.5T R5
The Issue: For some identified Ingenia systems shipped between December
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.