Class I - Dangerous
The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
Allergen Medical
Class I - Dangerous
Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured
Class I - Dangerous
Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
Class I - Dangerous
The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.
Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
Philips Healthcare
Class I - Dangerous
The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.
Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
Custom Healthcare Systems
Class I - Dangerous
Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
Class I - Dangerous
The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.
Class I - Dangerous
Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event.
Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event.
Class I - Dangerous
The length markings on the Lightspeed LSX files were wrong.
OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France
Hitachi Chemical Diagnostics
Class I - Dangerous
There is no evidence that a visual inspection was performed on one tray of coverslips. Possibility of a low fill volume which could lead to a false negative results.
Class I - Dangerous
Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
P10 Tobii battery box (product number 510410) Product Usage - Battery pack for MyTobii P10 Device. MyTobii P10 is a portable eye-controlled communication device featuring the Tobii Eye Control system.
Tobii Assistive Technology
Class I - Dangerous
Tobii ATI customers P10 external battery pack, which contains sealed lead-acid batteries, malfunctioned while recharging and produced smoke with a chemical smell.
Class I - Dangerous
Some VITROS¿ Chemistry Products Vapor Adsorption Cartridge CAT No. 6800100 cartons incorrectly contain a Particulate Cartridge Part No. J19612. In some instances, the Particulate Cartridge has been inadvertently installed on the VITROS¿ System instead of the intended VITROS¿ Vapor Adsorption Cartridge which may bias results.
Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
Varian Medical Systems
Class I - Dangerous
A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
Out of range (increased) HDL Cholesterol results.
Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications.
MOOG Medical Devices Group
Class I - Dangerous
The firm is adding an addendum to the operator's manual for Infinity Enteralite Ambulatory Feeding Pumps pertaining to the Infinite Dose mode and the inability of the Pump to detect air in line.
Thru hole at the tip of the screw is undersized.