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 29841–29860 of 38,428 recalls
Recalled Item: Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L
The Issue: The affected part and lot numbers of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prism Medical P-600 Portable Ceiling Lift
The Issue: There is a potential the sling loops may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires:
The Issue: Hardy Diagnostics is recalling HardyCHROM VRE Agar due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The EKOS EkoSonic Control Unit is intended exclusively for use
The Issue: The Connector Interface Cable (CIC) was not recognized
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 16mm Chisel Blade
The Issue: It was discovered that a 10mm Chisel Blade
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O-Two Adult Ventilation Timer
The Issue: Malfunction of an O-Two Adult Ventilation Timer, where
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer SST Plus Blood Collection Tubes
The Issue: Some of the tubes were manufactured with stoppers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Contour Next Control Solution for Contour Next Blood Glucose Test
The Issue: If the control solution bottle is not thoroughly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fabius MRI Anesthesia Machine
The Issue: the Fabius MRI or parts of the system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3...
The Issue: A software issue was discovered where an inaccurate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3...
The Issue: A software issue was discovered where an inaccurate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions...
The Issue: A software issue was discovered where an inaccurate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3...
The Issue: A software issue was discovered where an inaccurate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3...
The Issue: A software issue was discovered where an inaccurate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3...
The Issue: A software issue was discovered where an inaccurate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abutment Retrieval Instrument Zirconia CC RP/WP
The Issue: One dimension of the affected instrument is incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium 36Fr Right Angled Firm PVC Thoracic Catheter
The Issue: Inner pouches incorrectly labeled as part 8136, 36Fr
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed NGP 640G 1.8ml (mmol/L)
The Issue: Medtronic MiniMed is recalling the MiniMed 620G and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product
The Issue: Incorrect expiration date on outer carton kit label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can
The Issue: defect in the forming of the primary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.