Class I - Dangerous
Label does not state that the product is heparin-coated.
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Surgical Instruments
🏥 Medical Devices • 7,015 recalls
Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures.
Boston Scientific
Class I - Dangerous
Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console.
Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
Boston Scientific
Class I - Dangerous
Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console.
A customer complained that one of the pouches in a box of 10 had "QuikClot Roll" pouch instead of "QuikClot TraumaPad" pouch. The carton as well as the remaining 9 pouches were properly identified as QuikClot Trauma Pad. The customer alleged that when the pouch was opened, it contained a QuikClot TraumaPad. All 10 pouches in the box had the correct part number, lot number, and expiration date for the prod uct (QuikClot TraumaPad).
Class I - Dangerous
Product not meeting the iodine assay level requirements to support 36 month expiration dating.
Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
Degania Silicone
Class I - Dangerous
Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only.
Class I - Dangerous
Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.
Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.
Class I - Dangerous
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
Class I - Dangerous
Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.
Class I - Dangerous
Product was placed into distribution prior to completion of all required post sterilization release activities.
Class I - Dangerous
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpose of archiving and teaching.
Trumpf Medical Systems
Class I - Dangerous
The radiated emission from the TruVidia" Wireless Receiver is above the normative accepted limits, in which the radiated emission may interact with other devices in the operating room and cause them not to function properly.
Class I - Dangerous
Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.
Class I - Dangerous
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
3M Surgical Clipper Professional 9681
3M Company - Health Care Business
Class I - Dangerous
Failure to follow proper charging practices can result in lithium-ion battery degradation, characterized by excessive heat during operation or failure to properly charge. In rare circumstances, battery degradation has been associated with battery venting, which is a rapid release of battery energy.
MOOG Curlin Infusion Administration Set, Ref 340-4133, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Needleless Injection Port (Positive Pressure), packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.
Zevex Incorporated (dba Moog Medical Medical Devices Group)
Class I - Dangerous
Particulate found on the Curlin spike.
Class I - Dangerous
Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility.
MOOG Curlin Infusion Administration Set, Ref 340-4169, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Ultrasite Needleless Injection Port (Positive Pressure), Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.
Zevex Incorporated (dba Moog Medical Medical Devices Group)
Class I - Dangerous
Particulate found on the Curlin spike.
Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.