Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use
💧
Infusion Pumps
🏥 Medical Devices • 4,350 recalls
Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use
Potential incorrect Standardized Uptake Values (SUV) measurements in RadSuite.
Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)
Class I - Dangerous
Moog is recalling Curlin 4000, 6000, and PainSmart Infusion Pumps manufactured or serviced by MMDG between March 18, 2015 and November 6, 2015 because the master pumps used to calibrate them were out of tolerance and may cause an over delivery of medications and solutions at a rate of 1.2 - 6.8% faster than programmed.
Class I - Dangerous
Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.
Synthes Small Electric Drive (SED). For use in general traumatology.
The Anspach Effort
Class I - Dangerous
The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start.
Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue.
MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use.
Owens & Minor Distribution
Class I - Dangerous
MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination.
Class I - Dangerous
Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.
MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging]. General Hospital Use.
Owens & Minor Distribution
Class I - Dangerous
MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination.
MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use.
Owens & Minor Distribution
Class I - Dangerous
MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination.
Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.
Bard Peripheral Vascular
Class I - Dangerous
IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys.
Class I - Dangerous
Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled.
Class I - Dangerous
Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an inaccurate display of instruments by the navigation system compared to the actual patient anatomy.
FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
DePuy Mitek, Inc., a Johnson & Johnson
Class I - Dangerous
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
DePuy Mitek, Inc., a Johnson & Johnson
Class I - Dangerous
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
Class I - Dangerous
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results.
Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results.