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 29041–29060 of 38,428 recalls
Recalled Item: Brilliance iCT SP Computed Tomography X-ray system
The Issue: Perfusion scan feature may not be available on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 64 Computed Tomography X-ray system
The Issue: Perfusion scan feature may not be available on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage System One S Cycler (High Permeability Hemodialysis System) Model
The Issue: Ultrafiltration (UF) Volume software error inaccurate fluid removal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage System One S Cycler -High Permeability Hemodialysis System Model
The Issue: Ultrafiltration Volume (UFV) may not decrease during treatment-software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage System One S Cycler - Model no. NX1000-3-A (OUS).
The Issue: Ultrafiltration Volume (UFV) may not decrease during treatment-software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis.
The Issue: Ultrafiltration Volume (UFV) may not decrease during treatment-software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage System One S Cycler (High Permeability Hemodialysis System) Model
The Issue: Ultrafiltration (UF) Volume software error inaccurate fluid removal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DA-2006P - Defibrillator / Pacer Analyzer
The Issue: Device is not functioning as intended: Two wires
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DGDE
The Issue: Implant Direct Sybron Manufacturing, LLC is recalling 26
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProTrack Microcatheter. Model/Catalog Numbers CIC38-145
The Issue: Microcatheter may have circumferential defects (cracks) along its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes
The Issue: The products have been found to intermittently exhibit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo Imaging VB36D_HF02. Radiological image processing system.
The Issue: To provide supplementary information regarding the release of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: rainbow Reusable Sensors. RAINBOW DCI-DC3
The Issue: These sensors were manufactured with incompatible configurations. This
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Perfusion Tubing Packs
The Issue: This recall is being initiated due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: U-SDN 2 Part Ultra Modified Seldinger Needles
The Issue: The firm had received a complaint alleging that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IOL Master 500: Software versions 7.5 and 7.7
The Issue: IOL Master software versions 7.5 and 7.7 calculation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IOL Master 5.5: Software versions 7.5 and 7.7
The Issue: IOL Master software versions 7.5 and 7.7 calculation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product
The Issue: It was discovered that the labeling of MS-230
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cavity 8 Gauge Spine Wand indicated for resection
The Issue: There is cracking in the tray when the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly
The Issue: The firm, Merge Healthcare, sent out Merge HEMO
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.