California recalls

May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.

In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.

Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.

Due to out-of-specification, or potential out-of-specification, levels of endotoxins

The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating tables.

Potential sterile breach of the pouches in which devices are packaged.

Potential sterile breach of the pouches in which devices are packaged.

Potential sterile breach of the pouches in which devices are packaged.

Potential sterile breach of the pouches in which devices are packaged.

Potential sterile breach of the pouches in which devices are packaged.

Potential sterile breach of the pouches in which devices are packaged.

Potential sterile breach of the pouches in which devices are packaged.

Potential sterile breach of the pouches in which devices are packaged.

Potential sterile breach of the pouches in which devices are packaged.

Potential sterile breach of the pouches in which devices are packaged.

Potential sterile breach of the pouches in which devices are packaged.

Potential sterile breach of the pouches in which devices are packaged.

Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.

Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.

Reduced or no recovery of some strains of Neisseria gonorrhoeae.

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than intended, which may increase the risk of fracture in the medial region of the proximal humerus.

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.