Galaxy Bronchoscope Biopsy Tool Insertion Risk at Sharp Bend Angles
Noah Medical is recalling Galaxy bronchoscope units due to risk that biopsy tools may require excessive force or fail to pass through the scope channel when the bronchoscope is sharply bent, potentially causing tissue injury or pneumothorax.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving risk of serious injury (tissue damage and pneumothorax). No illnesses or injuries have been reported to date. Per the rubric, this qualifies as 'High'—a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Noah Medical is recalling Galaxy bronchoscope units (GALB-001), part of the Galaxy System (GAL-001). The recall affects 26 bronchoscopes distributed nationwide across 14 states.
The issue occurs when biopsy tools designed to fit the bronchoscope channel (2.1mm inner diameter, length greater than or equal to 1100mm) are used while the scope's bending section is positioned at a sharp angle (greater than 100 degrees). In this position, tools may be difficult to insert or may require excessive force. Instruments with long rigid distal sections are particularly susceptible to insertion resistance.
Excessive force during tool insertion poses risk of tissue injury or pneumothorax (collapsed lung). The recall applies to all bronchoscope lots used with 26 specific system serial numbers (CRB-1502 through CRB-1554).
Healthcare facilities should review their procedures for biopsy tool insertion, avoid forcing instruments through sharply bent channels, and contact Noah Medical for further guidance on device management.
The recalled product
- Product
- Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
- Manufacturer
- Noah Medical
- Hazard
- tissue-injury
- pneumothorax
- insertion-resistance
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- CRB-1503
- CRB-1508
- CRB-1513
- CRB-1514
- CRB-1515
- CRB-1516
- CRB-1518
- CRB-1519
- CRB-1520
- CRB-1521
- CRB-1522
- CRB-1523
- CRB-1524
- CRB-1525
- CRB-1528
- CRB-1530
- CRB-1532
- CRB-1534
- CRB-1535
- CRB-1537
Distribution
Distributed nationwide across the United States.
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