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 26981–27000 of 38,428 recalls
Recalled Item: Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 4
The Issue: Stryker Neurovascular has become aware that some units
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Target Detachable Coils: TARGET 360 NANO 1 MM X 2
The Issue: Stryker Neurovascular has become aware that some units
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL
The Issue: Stryker Neurovascular has become aware that some units
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SYNGO Breast Care
The Issue: Software issues. Siemens is voluntarily initiating a recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip
The Issue: Impactors do not meet the required sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K
The Issue: Labeling error. Some shipping cartons labeled as ASK-04018-VUH
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products Total T4 Reagent Pack
The Issue: Ortho-Clinical Diagnostics confirmed that sample results generated from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Parker Trach-Vac Endotracheal Tubes. Tyvek pouches
The Issue: Parker Medical announces a voluntary field action for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K
The Issue: Labeling error. Some shipping cartons labeled as ASK-04018-VUH
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROW
The Issue: Arrow is recalling these products due to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec &
The Issue: BD has determined that the PhoenixSpec AP Calibrator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SimpliRED D-Dimer
The Issue: A component of the kit is showing a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec
The Issue: BD has determined that the BBL PhoenixSpec Calibrator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203
The Issue: Product defect; tip of two (2) Angiographic Catheters
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrasound Video Bronchoscope The EB-1970UK
The Issue: The EB-1970UK Ultrasound Video Bronchoscope shipped between the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pentax Video Bronchoscope Designed to be used with a Pentax
The Issue: Pentax America Inc. is recalling various bronchoscopes which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: METS SMILES Total Knee Replacement
The Issue: The manufacturer has identified that the stated Femoral
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxylog 3000
The Issue: Isolated episodes of leakage at the check valve
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATEC CANISTER. Suction Canister with Lid 490 cc.
The Issue: Cracks ATEC Canister Lids
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Part # SD313.012
The Issue: DePuy Synthes is voluntarily initiating this recall due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.