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 29341–29360 of 38,428 recalls
Recalled Item: Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE
The Issue: Custom Cardiovascular Procedure Kits contain recalled component Medivators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02
The Issue: Custom Cardiovascular Procedure Kits contain recalled component Medivators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N:
The Issue: Custom Cardiovascular Procedure Kits contain recalled component Medivators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01
The Issue: Custom Cardiovascular Procedure Kits contain recalled component Medivators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N:
The Issue: Custom Cardiovascular Procedure Kits contain recalled component Medivators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number:
The Issue: RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124
The Issue: Custom Cardiovascular Procedure Kits contain recalled component Medivators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number:
The Issue: RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number:
The Issue: RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude
The Issue: breach of the sterile barrier packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monode
The Issue: Overheating and burning of the wire insulation inside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Universal Compact Head Ring Adapter Plate (UCHRAP)
The Issue: Integra identified that the UCHRAP component (Arc Adapter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180
The Issue: Insufficient information for specific cleaning accessories used for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aliquot Delivery Kit (Syringe and Plunger)
The Issue: Two isolated instances of holes in the outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Distal Access Catheters - 044 - 115 cm: Finished Good
The Issue: One Distal Access Catheter intended for distribution in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regard Custom Surgical Pack
The Issue: Surgical kits contain a surgical scrub product which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regard Custom Surgical Pack
The Issue: Surgical kits contain a surgical scrub product which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON SC2000 Ultrasound System with software versions VB10B and lower
The Issue: The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO Shoulder Retractors
The Issue: The wrist straps used for positioning the patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MediTrace Cadence Adult Zoll
The Issue: Multi-Function Defibrillation Electrodes, Pre connect- potential for damage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.