Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
All Recalls
95,025 total recalls in our database
Oceanic Adult Dry Top Snorkels
Unique Sea Products, of Thailand
The bottom purge valve on the recalled snorkels can leak, allowing unexpected water entry, posing a drowning hazard.
Bauer Forced Air Propane Portable Heaters
Unknown Manufacturer
The fitting at the back of the heater can fail to be sufficiently tight, causing the heater to leak propane gas, posing a fire hazard.
E-Z-GO PTVs and Tracker Off-Road Vehicles
Textron Specialized Vehicles, of Augusta, Georgia
The parking brake catch bracket can wear out and cause the parking brake to fail, posing a crash hazard.
Some packages of Trader Joe's Super Spinach Salad were prepared using almonds instead of pumpkin seeds, which are declared on the label. Undeclared allergen - almonds.
Undeclared egg allergen
contains undeclared milk
CGMP Deviations: Product contains acetaldehyde and acetal above the allowable limits.
CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits.
Subpotent
Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
Micro Therapeutics Inc,
Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Potential defective gas inlet pressure regulator within ventilator which could result in gas releasing noise from the bottom of the ventilator, a High Air/O2 Inlet Pressure alarm, a High/Low O2 alarm, or could not pass device Check prior to use.
Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Ion Beam Applications S.A.
Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment
Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995477
Siemens Healthcare Diagnostics
Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.
Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
Angiodynamics
Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.
There is potential for nonsterility of product due to a possible defect in the pouch seal.