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 10801–10820 of 38,428 recalls
Recalled Item: Merlin PCS 3650 programmer Model 3330 software
The Issue: Due to a programmer software anomaly under very
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q
The Issue: Bluetooth malfunction impacting Gallant devices post-implant. The failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EasyFuse Dynamic Compression System Instrument Pack
The Issue: The drill and adjustable drill guide can jam/bind
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Synapsys Microbiology Informatics Solution
The Issue: When updating BD Kiestra customers to BD Synapsys
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RocheDiabetes Care Platform Software version 2.5.2 material number...
The Issue: for patient data mismatch when using browser
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4.0mm x 10mm Cannulated Screw
The Issue: Cannulated Screws 4.0mm x 10mm and 4.0mm x
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4.0mm x 12mm Cannulated Screw
The Issue: Cannulated Screws 4.0mm x 10mm and 4.0mm x
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Standard PVC Laryngeal Masks
The Issue: The mask cuff may disconnect from the device's
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BF-MP60: OES Bronchofiberscope
The Issue: Bronchofiberscope Updated instructions on the use of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BF-3C160: EVIS EXERA Bronchovideoscope
The Issue: Bronchofiberscope Updated instructions on the use of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BF-MP160F: EVIS EXERA Bronchofibervideoscope
The Issue: Bronchofiberscope Updated instructions on the use of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BF-1TQ180: EVIS EXERA II Bronchovideoscope
The Issue: Bronchofiberscope Updated instructions on the use of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product
The Issue: Disconnection of the OnGuard2 Bag Adaptor SP from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROTAWIRE Drive and wireClip Torquer
The Issue: Pouch seals may be open, compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROTAWIRE Drive and wireClip Torquer
The Issue: Pouch seals may be open, compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards
The Issue: The product was stored incorrectly due to improper
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size
The Issue: Product was improperly store which may cause a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT STAT Myoglobin Calibrators
The Issue: This calibrator lot did not meet acceptance criteria
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Acuson 9vE4 Transducer
The Issue: Transducers (component of ultrasound system) may exceed recommended
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: syngo.via RT Image Suite upgraded to VB60 running on SOMATOM
The Issue: Upgraded software version makes an automatic change in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.