Class I - Dangerous
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover
Custom Medical Specialties
Class I - Dangerous
No endotoxin (LAL) testing to proper level.
GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH
Philips Medical Systems (Cleveland)
Class I - Dangerous
The TF Big Bore patient table experienced mechanical binding during horizontal table motion resulting in an automatic Emergency Stop (E-stop). An E-Stop will interrupt a current scan, resulting in an incomplete study.
Class I - Dangerous
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
Class I - Dangerous
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 Orthopaedic - filler, bone void
Medtronic Sofamor Danek USA
Class I - Dangerous
Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2.5 cm x 5 cm.
Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container.
Fresenius Medical Care Holdings
Class I - Dangerous
Bicarbonate Jug Adapter distributed prior to 510(k) approval
Class I - Dangerous
Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark.
Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
Siemens Medical Solutions USA
Class I - Dangerous
During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo CT2013B.
Class I - Dangerous
Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.
Medtronic Cardiovascular Surgery-the Heart Valve Division
Class I - Dangerous
Medtronic, Inc. initiated a recall of Medtronic Mosaic Aortic Obturator Model 7305 used with the Mosaic Porcine Aortic Bioprosthesis, Model Number 305, because of higher-than-expected transvalvular gradients occurring post implant.
Class I - Dangerous
Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark.
Class I - Dangerous
When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect.
Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
Class I - Dangerous
Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.
CareFusion 303
Class I - Dangerous
CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they may have a defect in the trifurcated component that could result in a component leak.
Class I - Dangerous
Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
IMPAX RIS QDOC 5.8
AGFA
Class I - Dangerous
Patient name displayed (printed) on the Patient Report was the wrong patient name.
The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient