Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length; Item Number: 47-2490-098-00
Zimmer Biomet
Class I - Dangerous
Potential failure of sterile packaging seal.
🏥
Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
ZMS Intramedullary Fixation Smooth Guide Wire 2.4 mm Diameter, 100 cm Length; Item Number: 47-2237-033-00
Zimmer Biomet
Class I - Dangerous
Potential failure of sterile packaging seal.
The secondary packaging is labeled with an incorrect expiration date.
The secondary packaging is labeled with an incorrect expiration date.
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.
Class I - Dangerous
Potential failure of sterile packaging seal.
Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2490-097-00
Zimmer Biomet
Class I - Dangerous
Potential failure of sterile packaging seal.
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.
A component of the kit was found to contain bacterial contamination.
Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.
Terumo Cardiovascular Systems
Class I - Dangerous
Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation).
Class I - Dangerous
There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles.
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.
Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length; Item Number: 47-2490-098-01
Zimmer Biomet
Class I - Dangerous
Potential failure of sterile packaging seal.
Class I - Dangerous
Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user.
PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Siemens Medical Solutions USA
Class I - Dangerous
Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;
Carefusion 2200
Class I - Dangerous
The integrity of the sterile packaging is potentially compromised.
Class I - Dangerous
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling and monitoring patient temperature .
Terumo Cardiovascular Systems
Class I - Dangerous
Update to cooler-heater cleaning instructions.
The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
Thoracentesis/ Paracentesis Kit 10/CS; STERILE;
Carefusion 2200
Class I - Dangerous
The integrity of the sterile packaging is potentially compromised.