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Showing 64621–64640 of 68218 results

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Boston Scientific: Boston Scientific Cutting Balloon Ultra2 Monorail Device...

Lack of assurance of sterility (pre-sterilization bioburden limits exceeded)

FDAJul 21, 2006Nationwide• Boston Scientific

Roche Diagnostics Corp.: Roche/Hitachi K Electrode, a potassium electrode for use ...

Expired product (dated 2006.06) was shipped as replacement for recalled product.

FDAJul 21, 2006Nationwide• Roche Diagnostics Corp.

Cordis Corporation: CORDIS SV-8 Steerable Guidewire, 180 cm. , 5 Steerable Gu...

Tip separation-Cordis SV-5 and SV-8 Steerable Guidewires may have a potential for guidewire fracture resulting in tip separation.

FDAJul 21, 2006PR• Cordis Corporation

Microvision Medical Holding B.V. Meibergdreef 45 Amsterdam Netherlands: MicroScan Lens Disposable Plastic Cap used with MicroScan...

Some lenses may have microscopic holes in the disposable caps representing a potential break in the sterile barrier

FDAJul 21, 2006CA, IN, IA +4 more• Microvision Medical Holding B.V. Meibergdreef 45 Amsterdam Netherlands

Medtronic Neurological: Medtronic Intrathecal Catheter, Model 8731, (part of infu...

Tip dislodgement during implantation-Medtronic is recalling Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit because the platinum-iridium tip may be dislodged by the guide wire during implantation.

FDAJul 21, 2006Nationwide• Medtronic Neurological

Medline Industries Inc: Medline Strider Midi 3 Scooter; a three wheeled battery o...

The P&G Solo 60A electronic control unit on the Midi Scooters may overheat.

FDAJul 20, 2006Nationwide• Medline Industries Inc

Medline Industries Inc: Medline Strider Maxi 4 Scooter; a four wheeled battery op...

Under conditions of heavy use, signs of overheating of the main battery cables have been observed.

FDAJul 20, 2006Nationwide• Medline Industries Inc

Medline Industries Inc: Medline Strider Midi 4 Scooter; a four wheeled battery op...

The P&G Solo 60A electronic control unit on the Midi Scooters may overheat.

FDAJul 20, 2006Nationwide• Medline Industries Inc

Zimmer Inc.: Zimmer Trabecular Metal Reverse Shoulder System Glenosphe...

Components may not lock together as intended.

FDAJul 20, 2006Nationwide• Zimmer Inc.

Medline Industries Inc: Medline Strider Maxi 3 Scooter; a three wheeled battery o...

Under conditions of heavy use, signs of overheating of the main battery cables have been observed.

FDAJul 20, 2006Nationwide• Medline Industries Inc

Medtronic Neurological: Medtronic Kinetra Dual Program Neurostimulator for Deep B...

A subset of Kinetra implantable neurostimulators may experience a failure of wire connections between the electronic hybrid circuit and battery which may lead to sudden cessation of therapy. Sudden cessation of therapy can result in the immediate return or worsening of underlying symptoms due to the progression of the disease state.

FDAJul 19, 2006PR• Medtronic Neurological

Invacare Corporation: Kuschall''s K3/K4 Series of Manual Wheelchair, Model Airl...

If the user has chosen to install optional anti-tippers on the chair, the anti-tipper as designed may not be able to bear the stress of repeated or quick loads placed on it, causing the bolt to bend or break.

FDAJul 18, 2006Nationwide• Invacare Corporation

Therakos Inc: Therakos Photopheresis Procedural Kit for use with the UV...

Centrifuge Bowl may leak

FDAJul 18, 2006Nationwide• Therakos Inc

Plus Orthopedics USA: UC-PLUS Solution Unicondylar Knee System, Model Numbers:...

The modified devices were distributed by Plus Orthopedics USA (Plus USA) June 10, 2003 prior to FDA approval to market of the modified device (Special 510(k) K032052, clearance date July 25, 2003) and withdrawn from the field June 25, 2003.

FDAJul 18, 2006CA• Plus Orthopedics USA

Plus Orthopedics USA: UC-PLUS Solution Unicondylar Knee System, Model Numbers:...

There exists the possibility that incomplete bony support or insufficient cementing of the implanted device can result in fatigue fracture of the UC-PLUS Solution Femoral Component.

FDAJul 18, 2006CA• Plus Orthopedics USA

Enpath Medical, Inc: Enpath Lead Adapters, pacemaker lead adapter. Affects: 5...

Enpath Lead Adapters: The internal component (Connector Block) of the Lead Adapter used to secure a lead to the adapter has exhibited varying degress of radial cracks that could cause a temporary intermittent electrical signal disruption if lateral tension is applied to device.

FDAJul 18, 2006CA, MN, NJ• Enpath Medical, Inc

Louisville Apl Diagnostics Inc: APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in v...

Product mislabeled; outer container labeled with incorrect lot number.

FDAJul 18, 2006IN• Louisville Apl Diagnostics Inc

Radiometer America Inc: SafePICO Samplers, self-filling arterial blood samplers. ...

Leaking Tip Caps-Tip caps may leak; after air has been expelled from the syringe through the vented safe tip caps.

FDAJul 18, 2006Nationwide• Radiometer America Inc

Diagnostica Stago, Inc.: Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal P...

Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants.

FDAJul 18, 2006Nationwide• Diagnostica Stago, Inc.

Enpath Medical, Inc: Angel Medical Systems Lead Adaptor system adapts a St. Ju...

The internal component (Connector Block) of the Lead Adapter used to secure a lead to the adapter has exhibited varying degress of radial cracks that could cause a temporary intermittent electrical signal disruption if lateral tension is applied to device.

FDAJul 18, 2006CA, MN, NJ• Enpath Medical, Inc

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