Class I - Dangerous
Dimensional non-conformity of the thread on the screw head.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Failure to correctly document the installation of four M12 Bolts into the system rotor.
Class I - Dangerous
Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.
Class I - Dangerous
Dimensional non-conformity of the thread on the screw head.
Bard Access Systems announces a voluntary field action for the StatLock¿ Catheter Stabilization Devices because some single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.).
ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a device which should contain a 60 drop drip chamber.
SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device
C.R. Bard
Class I - Dangerous
The product contained a latex catheter instead of a silicone catheter.
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
Class I - Dangerous
GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.
ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices.
Bard Access Systems announces a voluntary field action for the StatLock¿ Catheter Stabilization Devices because some single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.).
Class I - Dangerous
Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a printing error where k-wire description markings indicate diameters of 0.45 and 0.35 instead of 0.045" and 0.035", respectively.
Class I - Dangerous
According to firm ( Bausch & Lomb, Inc. ) on June 17, 2016 a packaging operator notified his supervisor he had not placed the operating instruction into the last repackaging of SKU 0816 C (Pterygium Burr Medium Diamond). Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction. Therefore Bausch & Lomb is proposing a Field Correction to provide customer purchasing product from April 30, 2012 to June 20, 2016 with the current operating instruction.
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
Class I - Dangerous
Dimensional non-conformity of the thread on the screw head.
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
Class I - Dangerous
Bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-Injection Site and MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site devices because sets may contain one or more units where the needle length and gage differs from the length and gage described on the label.
Class I - Dangerous
Cross profile for Varian 60 degree wedge shows "horns."
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.