Class I - Dangerous
A potential commingle that could result in the product in the package not matching the product on the outer label.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
Ace Surgical Supply Co.
Class I - Dangerous
The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade.
T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment
Stryker Instruments Div. of Stryker
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection garment
Stryker Instruments Div. of Stryker
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing the humeral canal and/or trialing. All cases resulted in a delay in surgery, with a variance of medical intervention required.
Class I - Dangerous
There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has added a statement to the device's Instructions for Use to make surgeons aware of risks in using the device in Transversus Abdominis Muscle Release (TAR) procedures.
Class I - Dangerous
A previously "in specification" Finished Product with a Model 25-0657 diode had power output higher than 5 mW.
BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344
Becton Dickinson & Company
Class I - Dangerous
Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
Diagnostic Hybrids
Class I - Dangerous
A component of the kit was found to contain bacterial contamination.
T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment
Stryker Instruments Div. of Stryker
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal protection garment
Stryker Instruments Div. of Stryker
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12 (Catalog no 367342)
Becton Dickinson & Company
Class I - Dangerous
Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal protection garment
Stryker Instruments Div. of Stryker
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal protection garment
Stryker Instruments Div. of Stryker
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Class I - Dangerous
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Thoracentesis/ Paracentesis Kit 10/CS; STERILE;
Carefusion 2200
Class I - Dangerous
The integrity of the sterile packaging is potentially compromised.
Class I - Dangerous
Surview scan with tube current lower than 30 mA is unable to be initialized.
Class I - Dangerous
The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater.
Class I - Dangerous
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Class I - Dangerous
Bags of solution may have a small leak at the base of the injection port where the port is welded into the body of the bag..