The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0656-2026·Announced 2025-12-03

Bronchoscopy robots recalled because the user manual was password protected

Noah Medical is recalling 47 Galaxy Systems because users did not have access to the Instructions for Use and User Manual, which was password protected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 because the record cites inaccessible instructions rather than a device defect, and states no consequence or reported harm.

Plain-English summary

The Galaxy System, model GAL-001, from Noah Medical, is being recalled. The system and its accessories are intended to provide bronchoscopic visualisation of and access to patient airways.

The recall follows users not having access to the Instructions for Use and User Manual because it was password protected.

The recall covers 47 units carrying UDI 00850048825048, with serial numbers listed in the customer notification letter. The product was distributed in New York, Massachusetts, West Virginia, Wyoming, Tennessee, Ohio, New Jersey, Minnesota, California, Missouri, Idaho, Indiana, Pennsylvania, Maryland, Virginia, Wisconsin, Colorado and South Carolina. The FDA has classified the action as Class II.

The enforcement record describes an access problem with the documentation rather than a device defect, and reports no injuries. Sites should follow Noah Medical's instructions to obtain the manual.

The recalled product

Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML…
Manufacturer
B Braun Medical Inc
Category
Medical Device — Bronchoscopy system
Hazard
Affected units
65,904

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 (3)

  • 1. Catalog Number: 490283
  • Primary UDI-DI: 04046964716669
  • Unit of Dose UDI-DI: 04046964716652.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 116 recalled by B Braun Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 116 products in this recall →

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