MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
CooperSurgical
Class I - Dangerous
A diaphragm size 80 labeled box was incorrectly packaged with a size 85.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. This prevents complete range of motion and if pushed too far may loosen the pin from the bone. A revision surgery may be necessary to adequately reconnect the fixator to the bone.
Class I - Dangerous
Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath.
BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample collection.
Becton Dickinson &
Class I - Dangerous
The products may exhibit indications of excessive oxidation. Excessive oxidation may affect the viability of anaerobic microorganisms.
Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
Vilex In Tennessee
Class I - Dangerous
Incidence of breakage is higher than expected.
Class I - Dangerous
Potential lack of sterility assurance.
FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
Maquet Cardiovascular Us Sales
Class I - Dangerous
In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas leakage within the system internal circuit potentially leading to a stop in ventilation.
Class I - Dangerous
Potential lack of sterility assurance.
Class I - Dangerous
Complaints with the HVAD Retraction of Pins within the driveline connector.
HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.
Class I - Dangerous
Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Set) where under-sized tubing was used in the production of 1 lot of product.
Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)
Advanced Back Technologies
Class I - Dangerous
Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs
Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)
Advanced Back Technologies
Class I - Dangerous
Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs
Class I - Dangerous
Potential device damage on the strain relief near the hub area, which may result in blood leakage.
Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
Vilex In Tennessee
Class I - Dangerous
Incidence of breakage is higher than expected.
Class I - Dangerous
Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2.
Recapper Caps may fall off of, or be knocked from sample tubes placed in the storage racks of entry/exit modules. The gripper may grab a tube at the wrong height and drop the tube in the Rack Entry/Exit or Rack Exit module. These situations may result in splashing of bio-hazardous fluid. Sample cross-contamination may occur with an uncapped tube in the rack.
Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled.
Compass Health Brands
Class I - Dangerous
Roscoe Medical has recently identified the need to update its user manual with additional warning statements regarding proper handling and storage of the nebulizer. These warnings are to better inform end users of proper care when using and storing a Roscoe Medical Nebulizer to reduce user damage (wear & tear) to the power cord.
AGFA DX-D 100 is a mobile digital radiography x-ray system
AGFA Healthcare
Class I - Dangerous
When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur.
Class I - Dangerous
Design of device may expose user to injury to fingers or body parts