Reported Dec 18, 2024 · Ongoing
Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy…
Noah Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Noah Medical · 1501 Industrial Rd · San Carlos, CA · 94070-4111
Is this the product you have?
- Galaxy bronchoscope (Product GALB-001) used with Instructions for use
- Part10000752, part of the Noah Medical Galaxy System (GAL-001)
- Lot codes and dates
- UDI-DI00850048825048
- IFU RevisionJ and all prior versions. All bronchoscope lots used with
- the following system serial numbers
CRB-1502CRB-1503CRB-1508CRB-1513CRB-1514CRB-1515CRB-1516CRB-1518CRB-1519CRB-1520CRB-1521CRB-1522CRB-1523CRB-1524CRB-1525CRB-1528CRB-1530CRB-1532CRB-1534CRB-1535CRB-1537CRB-1538CRB1540CRB-1541CRB-1543CRB1554
- Amount recalled
- 26
Where it was sold
Why it was recalled
Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in sharp bend (approx. greater than 100-deg.), excessive force may result in tissue injury/pneumothorax; instruments with long rigid distal sections may exhibit insertion resistance when bronchoscope bending section significantly articulated.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Noah Medical recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.