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 37641–37660 of 38,428 recalls
Recalled Item: GE Seno Advantage 1.x
The Issue: GE Healthcare has become aware of an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Advantage Workstations
The Issue: GE Healthcare is informing you of incorrect measurements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EkoSonic MACH4 Endovascular Device (Catalog #500-55106
The Issue: EKOS Corporation have recently received several complaints from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume
The Issue: GE Healthcare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LMA Esophageal Intubation Detector (EID)
The Issue: The recall was initiated because LMANA has received
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R)...
The Issue: The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bipolar Forceps model number: S02-XXX
The Issue: On 05/23/2012, Stingray Surgical Products, LLC., Boca Raton,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliSpace Portal software and Extended Brillance Workspace software...
The Issue: The Intellispace Portal software and Extended Brillance Workspace
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intellispace Portal software. Intellispace Portal is a multimodality thin client
The Issue: Philips is issuing a software update to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5
The Issue: The recall was initiated because Beckman Coulter has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TetraCXP Software System
The Issue: The recall was initiated because Beckman Coulter has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5
The Issue: The recall was initiated because Beckman Coulter has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD GeneOhm MRSA ACP Assay Catalog #441637
The Issue: Leakage in Cepheid SmartCycler reaction tubes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD GeneOhm VanR Assay
The Issue: Leakage in Cepheid SmartCycler reaction tubes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD GeneOhm MRSA ACP Assay
The Issue: Leakage in Cepheid SmartCycler reaction tubes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD GeneOhm Cdiff Assay
The Issue: Leakage in Cepheid SmartCycler reaction tubes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD GeneOhm Cdiff Assay
The Issue: Leakage in Cepheid SmartCycler reaction tubes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 .019.038S
The Issue: Two lots of 4.5mm multi-loc screws were recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 .019.028S
The Issue: Two lots of 4.5mm multi-loc screws were recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.