Bronchoscopes recalled after leak testing with equipment outside its operating range

Plain-English summary

The MONARCH Bronchoscope, model MBR-000211-B, from Auris Health, is being recalled.

The firm describes the potential that product was leak tested with equipment outside of its expected operating range, stating in the record that this resulted in bronchoscopes that may not be susceptible to leaks.

The recall covers 1,477 units, identified by serial number. The product was distributed nationwide, including Alabama, Arizona, California, Colorado, Connecticut, the District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico and New York. The FDA has classified the action as Class II.

The enforcement record describes a testing process deviation rather than a confirmed device defect, and reports no injuries. Facilities holding affected units should follow the firm's instructions.

The recalled product

Product

MONARCH Bronchoscope. Model Number: MBR-000211-B

Manufacturer

Auris Health, Inc

Category

Medical Device — Bronchoscope

Hazard

• testing-deviation
• leak-testing
• process-control

Affected units

1,477

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Related recalls