🏥 Medical Devices • 7,015 recalls
Becton Dickinson & Company
BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user.
Smiths Medical ASD
Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medical Corporation contained pin holes in the side wall of the hub. The defect was not detected during Smiths Medical incoming inspection. The syringe assemblies were used to manufacture seven (7) finished good lots of Hypodermic Needle Pro¿ needles, Smiths Medical part numbers EL 1915 and SB5021.
Sterilmed is recalling all lots of specific product codes of unexpired Sterilmed Reprocessed EP Ablation Cables because Sterilmed determined that the cables are Class III devices and thus require, but do not currently have, premarket review and approval.
Boston Scientific
Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon
Mallinckrodt Manufacturing
Product was improperly labeled leading to improper storage.
Boston Scientific
Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon
da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqued brake screws in a section of the system arms.
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
Cotton tip of the device may disengage due to insufficient adhesive