Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor...
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.
COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Numb...
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor...
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.
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed care and/or fluid overload.
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, ...
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.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor...
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 medical convenience kits, containing NAMIC Angiographic Rotating Adaptor...
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.
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X07...
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
See Luer Cap Set, MPC-130, set, administration, intravascular
Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer Cap Set based on a confirmed complaint of the threaded sleeve not being engaged and becoming un-attached.
COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-1...
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IM...
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001...
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port ...
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.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor...
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.
COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Re...
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 tes...
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.
NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG...
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 medical convenience kits, containing NAMIC Angiographic Rotating Adaptor...
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.
COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25...
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled...
Increased risk of purge leaks with Generation 1 purge cassettes.
Allura Xper FD20/20; System Code: 722038;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
MEDLINE ANTERIOR HIP PACK DYNJ64672B
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.