Medical Devices Recalls

Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.

Stryker Sustainability Solutions

Class I - Dangerous

Mislabeled for size

Apr 28, 2016 Diagnostic Equipment View Details →

American Surgical Ultracot 5 mm x 13 mm (Glassine) Ref Number: 23-02G Product Usage: Neurosurgical and Nonneurosurgical Sponges

American Surgical Company

Class I - Dangerous

Product packaging defective compromising sterility

Mar 31, 2016 Surgical Instruments Nationwide View Details →

American Surgical Ultracot 10 mm x 13 mm (Glassine) Ref Number: 23-03G Product Usage: Neurosurgical and Nonneurosurgical Sponges

American Surgical Company

Class I - Dangerous

Product packaging defective compromising sterility

Mar 31, 2016 Surgical Instruments Nationwide View Details →

Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.

Volcano

Class I - Dangerous

Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In specific circumstances, an impacted System will encounter unexpected data from the hospital network and be forced to reboot

Apr 25, 2016 Diagnostic Equipment Nationwide View Details →

American Surgical Delicot X 9 mm x 50 mm Ref Number: 63x07 Product Usage: Neurosurgical and Nonneurosurgical Sponges

American Surgical Company

Class I - Dangerous

Product packaging defective compromising sterility

Mar 31, 2016 Surgical Instruments Nationwide View Details →

American Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges

American Surgical Company

Class I - Dangerous

Product packaging defective compromising sterility

Mar 31, 2016 Surgical Instruments Nationwide View Details →

American Surgical Delicot non-xray 10 mm x 13 mm Ref Number: 63-03 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges

American Surgical Company

Class I - Dangerous

Product packaging defective compromising sterility

Mar 31, 2016 Surgical Instruments Nationwide View Details →

American Surgical Americot Blue 1/4" x 1.5" Ref Number: 20-30S Product Usage: Neurosurgical and Nonneurosurgical Sponges

American Surgical Company

Class I - Dangerous

Product packaging defective compromising sterility

Mar 31, 2016 Surgical Instruments Nationwide View Details →

ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line Catheters.

Hummingbird Med

Class I - Dangerous

Hummingbird Med Devices, Inc. is recalling ABG-HM-1 Hummi Micro Draw Blood Transfer because the connection between the "Hummi" Y connector and the yellow cannula hub may not be sufficiently secure enough and could separate while in use.

Oct 1, 2015 Surgical Instruments View Details →

American Surgical Americot Blue 1" x 3" Ref Number: 20-10S Product Usage: Neurosurgical and Nonneurosurgical Sponges

American Surgical Company

Class I - Dangerous

Product packaging defective compromising sterility

Mar 31, 2016 Surgical Instruments Nationwide View Details →

American Surgical Delicot non-xray 5 mm x 13 mm Ref Number: 63-02 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges

American Surgical Company

Class I - Dangerous

Product packaging defective compromising sterility

Mar 31, 2016 Surgical Instruments Nationwide View Details →

American Surgical Telfa 3/8" x 3" Ref Number: 80-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges

American Surgical Company

Class I - Dangerous

Product packaging defective compromising sterility

Mar 31, 2016 Surgical Instruments Nationwide View Details →

American Surgical Delicot 6 mm x 50 mm Ref Number: 63-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

American Surgical Company

Class I - Dangerous

Product packaging defective compromising sterility

Mar 31, 2016 Surgical Instruments Nationwide View Details →

Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.

Leica Microsystems

Class I - Dangerous

Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of antibody diluent will give reduced staining.

Mar 22, 2016 Infusion Pumps View Details →

Various trauma and sports medicine instruments and implants. Orthopedic manual surgical instrument.

Biomet

Class I - Dangerous

Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

Apr 1, 2016 Implants & Prosthetics Nationwide View Details →

Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories

Biomet

Class I - Dangerous

Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

Apr 1, 2016 Implants & Prosthetics Nationwide View Details →