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 33441–33460 of 38,428 recalls
Recalled Item: EZPass Nylon Monofilament Single Pack
The Issue: The nitinol wire or monofilament may buckle within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZPass Passer
The Issue: The nitinol wire or monofilament may buckle within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZPass Suture Retriever
The Issue: The nitinol wire or monofilament may buckle within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ExacTrac 5.5
The Issue: When using a specific plan update workflow in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infant Nasal CPAP (continuous positive airway pressure) Prong
The Issue: The Infant Nasal CPAP Prong has the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Disposable Centrifugal Pump with X-Coating
The Issue: During set-up and priming of the bypass circuit,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Disposable Centrifugal Pump without X-Coating
The Issue: During set-up and priming of the bypass circuit,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with...
The Issue: During set-up and priming of the bypass circuit,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bluephase style Light probe Pin-point 6>2 mm black REF #
The Issue: A stock check revealed broken glass fibers between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor...
The Issue: A small number of Vista Air Compressors were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath...
The Issue: Arrow is recalling the Arrow¿ Percutaneous Sheath Introducer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microline Renew Fenestrated Control Tip Grasper
The Issue: Grasper jaw may break when force is applied
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters
The Issue: Roche Diabetes Care has become aware the ACCU-CHEK
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box)
The Issue: The sterile barrier in the packaging may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire
The Issue: Merit Medical Systems, Inc. is voluntarily conducting a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merit Laureate Hydrophilic Guide Wire
The Issue: Discrepancy between the carton and unit labeling for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to
The Issue: It was determined that under rare environmental conditions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NavioPFSTM System
The Issue: Blue Belt Technologies is conducting a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes External Fixation Systems (Small
The Issue: Labeling changes have been made related to MR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex Low Dead Space Connector with Sideport
The Issue: One lot of 3.0mm sized Connectors, Product Reorder
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.