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 29021–29040 of 38,428 recalls
Recalled Item: MYLA CLINIC PATCH 3.3.0 CD Product Usage: MYLA is a
The Issue: MYLA¿ software connected to a Laboratory Information System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MYLA MASTER DVD V4.1 CLI Product Usage: MYLA is a
The Issue: MYLA¿ software connected to a Laboratory Information System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MYLA MASTER DVD V4.0 CLI Product Usage: MYLA is a
The Issue: MYLA¿ software connected to a Laboratory Information System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Irrigation Clip 30
The Issue: Assembled with the incorrect (smaller) front clips (component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted
The Issue: The firm has received 15 complaints over ten
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OmniPod¿
The Issue: Pod's needle mechanism fails to deploy or there
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OmniPod¿
The Issue: Pod's needle mechanism fails to deploy or there
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMS 4675 Angio Pack. For use in a general clinical procedure.
The Issue: AMS 4675 Angio Pack is recalled because this
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA...
The Issue: TFNA nails may have the locking mechanism too
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMS 4674 Custom Pack. For use in a general clinical procedure.
The Issue: AMS 4674 Custom Pack is recalled because this
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended
The Issue: It was discovered that the above part number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15
The Issue: There is a risk ECG electrodes of specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RBT
The Issue: An incorrect label reading 10.5mm and not the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis systems with large display from Siemens Medical Solutions USA
The Issue: Due to improper soldering in a limited number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD CD64 APC-R700
The Issue: Three lots of CD64 (MD22) are contaminated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device...
The Issue: A design change was initiated to update ROSA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity CT Computed Tomography X-ray system
The Issue: Perfusion scan feature may not be available on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance iCT Computed Tomography X-ray system
The Issue: Perfusion scan feature may not be available on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core 128 Computed Tomography X-ray system
The Issue: Perfusion scan feature may not be available on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core Computed Tomography X-ray system
The Issue: Perfusion scan feature may not be available on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.