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 36381–36400 of 38,428 recalls
Recalled Item: SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3
The Issue: Siemens became aware of a potential safety issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KODAK INSIGHT DENTAL FILM in SureSoft Packets
The Issue: Missing symbols and manufacturing information on the clear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031
The Issue: An inspection of IATD (Installation Acceptance Test Document)IA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Diagnost Stationary Radiographic System Models: 712020
The Issue: Installation Acceptance Test Document (IATD) non compliant with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips BuckyDiagnost Radiographic
The Issue: An inspection shows several IATDs (Installation Acceptance Test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Diagnost Stationary Radiographic System Models: 712020
The Issue: Installation Acceptance Test Document (IATD) non compliant with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merit Medical Systems Inc.
The Issue: A consumer complaint that a catheter was observed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage:
The Issue: The mirror icon on the bottom of each
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 45¿ Angle Driver / Z-H
The Issue: Greatbatch Medical has initiated a global voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Iconos R200 C20
The Issue: Siemens has become aware of a potential malfunction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number:
The Issue: Cement mixer used to prepare cement for surgery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery
The Issue: Cement mixer used to prepare cement for surgery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000.
The Issue: Cement mixer used to prepare cement for surgery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery
The Issue: Cement mixer used to prepare cement for surgery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs BleaseSirius Anesthesia Workstation
The Issue: A defect in CAS I/II Absorbers in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Senographe Essential System. The Senographe 2000D system generates
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atricure Inc.
The Issue: Products from lot no. 41865 may have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell
The Issue: Out of an abundance of caution, Ansell is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BREG Sterile Polar Pads
The Issue: The recall was initiated because Breg has determined
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and
The Issue: VS2+ screen may lock up and stop monitoring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.