CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
Medline Industries
Class I - Dangerous
On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
XTANT Medical Holdings
Class I - Dangerous
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
Class I - Dangerous
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Class I - Dangerous
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Class I - Dangerous
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Class I - Dangerous
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Class I - Dangerous
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108
Cook Incorporated
Class I - Dangerous
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Class I - Dangerous
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Class I - Dangerous
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Class I - Dangerous
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Class I - Dangerous
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor
Brahms GmbH
Class I - Dangerous
Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubleshooting steps to resolve. If Quality Controls are not performed according to the Instructions for Use, the underestimation of QC1 may go undetected and could contribute to falsely elevated sFlt-1/PlGF ratio results. A falsely elevated sFlt-1/PlGF ratio may result in a higher-risk classification for progression to preeclampsia with severe features potentially leading to intensified clinical monitoring.
Class I - Dangerous
Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
Siemens Medical Solutions USA
Class I - Dangerous
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.