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 12941–12960 of 38,428 recalls
Recalled Item: Diluent
The Issue: false negative or false positive results due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
The Issue: Failure to comply with the performance standard for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dasky Disposable Sampling Tube
The Issue: Verification and validation of the virus transport medium
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tritanium X TL Instruments - intervertebral fusion device with bone graft
The Issue: Stryker identified non-conforming instruments that are components of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Disposable Sampling Tube
The Issue: Verification and validation of the virus transport medium
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dasky Disposable Sampling Tube
The Issue: Verification and validation of the virus transport medium
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dasky Disposable Sampling Tube
The Issue: Verification and validation of the virus transport medium
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tibial Opening Wedge Osteotomy Plate
The Issue: It was discovered that five AR-13200ST-15.0 parts were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Remel Haemophilus Test Medium(100mm) 10/PK
The Issue: When tested with H. influenza ATCC 49247 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Remel Haemophilus Test Medium (150 mm) 10/PK
The Issue: When tested with H. influenza ATCC 49247 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ysio X.pree
The Issue: A patient image was assigned to a different
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AngioDynamics SafeSheath ULTRALITE 10F
The Issue: for open seal on sterile product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A610 Clinician Programmer Application for Deep Brain Stimulation Clinician...
The Issue: There are two issues within this correction action:
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK INVENTRA 7
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK Ilestro 7 VR-T
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK Ilestro 7 VR-T DX
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK ITREVIA 7
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK Ilestro 7 DR-T
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK ILIVIA 7
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.