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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images.

Siemens Medical Solutions USA

Class I - Dangerous

Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Controller assembly, could lead to the overheating of the assembly.

Jul 31, 2015 Diagnostic Equipment Nationwide View Details →

Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial baseplates via a locking wire mechanism.

Stryker Howmedica Osteonics

Class I - Dangerous

Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size #2 9mm (5531-G-209) was reported to be in a pack that was labelled as a CR insert (5530-G-209).

May 29, 2015 Implants & Prosthetics View Details →

Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities)

Winco Mfg.

Class I - Dangerous

Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.

Apr 2, 2015 Other Medical Devices Nationwide View Details →

Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile

Teleflex

Class I - Dangerous

Customer complaints reporting that the cobb connector detached from the main connector prior to use.

Nov 21, 2014 Other Medical Devices Nationwide View Details →

White Bronchial Double Lumen Tube Set (Right) Sterile

Teleflex

Class I - Dangerous

Customer complaints reporting that the cobb connector detached from the main connector prior to use.

Nov 21, 2014 Other Medical Devices Nationwide View Details →

Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

Winco Mfg.

Class I - Dangerous

Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.

Apr 2, 2015 Other Medical Devices Nationwide View Details →

Medline Electrical Clipper with Charging base The Electrical Surgical Clipper is intended for the removal of body hair from patients as required prior to surgery or other minor procedures.

Medline Industries

Class I - Dangerous

Charging base of surgical clippers overheats and smokes.

Jul 8, 2015 Surgical Instruments Nationwide View Details →

IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.

International Biophysics

Class I - Dangerous

It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.

Aug 7, 2015 Other Medical Devices Nationwide View Details →

Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbiology: The Cepheid X pert CT /NG Vagina Endocervical/ Specimen Collection Kit is designed to collect, preserve and transport patient Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical and vaginal specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.

Cepheid

Class I - Dangerous

Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit expiration date.

Jul 27, 2015 Infusion Pumps Nationwide View Details →

Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Microbiology: Xpert CT/NG Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis and Neisseria gonorrhoeae DNA in first-catch male and female urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.

Cepheid

Class I - Dangerous

Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit expiration date.

Jul 27, 2015 Infusion Pumps Nationwide View Details →

Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, (30/box), Product Code 51610. Intermittent catheter.

C.R. Bard

Class I - Dangerous

Potential breach of the sterile barrier packaging.

Jul 7, 2015 Surgical Instruments Nationwide View Details →

Siemens Symbia T Series, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images.

Siemens Medical Solutions USA

Class I - Dangerous

Jul 31, 2015 Diagnostic Equipment Nationwide View Details →

American Science & Engineering Inc,Gemini Cabinet X-ray system.

American Science & Engineering

Class I - Dangerous

During factory testing, we discovered that Gemini systems could, in rare circumstances, experience a fault that leads to a state in which X-rays are being produced but the X-ray indicator lights (located on the operator's console and on both ends of the tunnel) are not illuminated.

May 22, 2015 Other Medical Devices View Details →