Idaho recalls

The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion.

The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion.

Products may contain contamination, which may result in a darker or brown media color.

Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low results.

The possibility for this product that is intended for demonstration purposes only to be placed in patients.

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Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.

Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.

Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.

Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.

Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.

The impacted lot may not meet the required tensile strength specification.

The impacted lot may not meet the required tensile strength specification.

Potential contamination of Salmonella Richmond

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.