The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek packaging may affect the sterility of the device.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Blood blushing/leaking from the surface of the graft after implantation
GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re
Microbiological identification media may exhibit reduced levels of Vancomycin.
Class I - Dangerous
Blood blushing/leaking from the surface of the graft after implantation
IntelliVue Smart-hopping 1.4 GHz Access Point may experience unexpected signal loss of several minutes impacting wireless connectivity
Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt shower chair. Height adjustable four wheeled shower chairs for persons of various weights.
Etac Supply Center Ab
Class I - Dangerous
Etac is voluntarily conducting a field correction of the Etac Swift Mobil shower chair. If the Swift Mobil shower chair loses a caster and thus becomes instantly unstable, there is potiential risk for harm or injury.
The outer box label of the product was labeled with a down revision label which did not include the US labeling requirements, specifically the symbol descriptors and also the "Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician." This product was previously labeled for EU distribution only.
GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.
Class I - Dangerous
Blood blushing/leaking from the surface of the graft after implantation
GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re
Class I - Dangerous
Blood blushing/leaking from the surface of the graft after implantation
Class I - Dangerous
Blood blushing/leaking from the surface of the graft after implantation
The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner pouch labels did not match, although both referenced the same lot number. The Model Number on the outer box states UPN M003E345020 (4.5mm x 20 mm Neuroform 3 Stent) while the pouch label states UPN M003E3450300 (4.5mm x 30 mm Neuroform 3 Stent).
Class I - Dangerous
Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorrectly determine that a communication error has occurred. If this situation occurs, a buzzer will activate and a yellow triangle will be displayed on the System Status Computer screen that alerts the user of this error.
Class I - Dangerous
The firm became aware of the problem when a ratchet cover plate on a device was returned for repair showed signs of corrosion.
Class I - Dangerous
The incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device.
Microbiological identification media may exhibit reduced levels of Vancomycin.
Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure
Class I - Dangerous
Church and Dwight Co., Inc. has initiated a recall for Sodium Bicarbonate, USP produced by the Old Fort, OH Sodium Bicarbonate Production facility due to metal and other contamination.