The Recall Desk
HighFDA (Devices)·Z-0711-2022·Announced 2022-03-09

Bronchial Microbiology Brush Labeling Error—Cleared Only for Gastrointestinal Use

Hobbs Medical is recalling 38,357 Bronchial Microbiology Brushes due to labeling that incorrectly indicates bronchial use. The device is cleared only for gastrointestinal use.

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 device with labeling that misidentifies the intended anatomical site of use (bronchial rather than gastrointestinal), presenting a risk of harm if the device is used in the unintended body system. No injuries or illnesses have been reported, placing this at the high-risk-of-harm-without-reported-injury level per the rubric.

Plain-English summary

Hobbs Medical, Inc. is recalling 38,357 Bronchial Microbiology Brushes (catalog numbers 4310 and 4320) distributed nationwide in the United States. The affected devices were distributed from January 18, 2017 through August 26, 2021, with expiration dates ranging from January 1, 2022 to December 1, 2026.

The device labeling identifies the product as a Bronchial Microbiology Brush. However, the device is cleared by the FDA only for gastrointestinal use, not for bronchial use. This discrepancy between the labeling and the device's cleared indication creates a risk that the device could be used inappropriately in the wrong body system.

Healthcare providers should review their use of these devices. Questions about the recall should be directed to the recalling manufacturer, Hobbs Medical, Inc. The FDA has classified this as a Class II recall.

The recalled product

Product
Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compression on the spring which retracts the brush back into the shea
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device
Hazard
  • mis-labeling
  • incorrect-indication

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 (5)

  • Package DI M84943100
  • Package DI Number M84943101
  • Catalog Number 4320
  • Package DI M84943200
  • Package DI Number M84943201

Distribution

Distributed nationwide across the United States.

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