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 27701–27720 of 38,428 recalls
Recalled Item: Poly-bags containing splint strap labeled with "Pediatric" sticker. Each strap
The Issue: On March 9, 2016, the firm was contacted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Poly-bags containing the strap labeled with "Adult" sticker. Each strap
The Issue: On March 9, 2016, the firm was contacted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: eCareCoordinator allows the customer to schedule patient tasks (i.e.
The Issue: The adherence check generates a software error. Two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent
The Issue: The reagent pack may result in elevated platelet
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 560 Hematology Systems
The Issue: Software anomaly; Siemens identified that software version 1.4.2133
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T
The Issue: Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hamilton G5 with software version between v2.41
The Issue: After performing the suctioning maneuver, including disconnecting the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient
The Issue: Panorama Central Station including the work station View
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: All instrumentation associated with the Prelude PF Resurfacing Knee System.
The Issue: Inadequate design control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liko Universal SlingBars Universal SlingBar" 350
The Issue: The center bolt of the sling bar, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syva Emit Methotrexate Assay
The Issue: Siemens Healthcare Diagnostics confirmed that Syva Emit Methotrexate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diana Automated Compounding System
The Issue: ICU Medical Inc. has received a report of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diana Automated Compounding System
The Issue: ICU Medical Inc. has received a report of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diana Automated Compounding System
The Issue: ICU Medical Inc. has received a report of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diana Automated Compounding System
The Issue: ICU Medical Inc. has received a report of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diana Automated Compounding System
The Issue: ICU Medical Inc. has received a report of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diana Automated Compounding System
The Issue: ICU Medical Inc. has received a report of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Helios HL3T and HLT Track Mounted Dental Lights Product Usage:
The Issue: The firm received two customer complaints local Pelton
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
The Issue: Reports relating to unintended patient or operator burns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
The Issue: Reports relating to unintended patient or operator burns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.