Bronchial Microbiology Brush
Medical device recall Z-0711-2022. Published in FDA’s Enforcement Report on Mar 9, 2022.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 9, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 38,357 devices how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. The device is only cleared for gastrointestinal use and is not cleared for bronchial use.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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 sheath. A protector tip on the end of the brush prevent contamination of the sample during the endoscopy procedure. The force required to dislodge the tip from the bristle is greater than to break the brush wire at the handle body.
38,357 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Affected lots were distributed in the United States from 1/18/2017 to 8/26/2021. These lots have expiration dates of 1/01/2022 through 12/01/2026. Catalog Number 4310, Package DI M84943100, Package DI Number M84943101; Catalog Number 4320,…
Every code shown here, 1,998 characters
Affected lots were distributed in the United States from 1/18/2017 to 8/26/2021. These lots have expiration dates of 1/01/2022 through 12/01/2026. Catalog Number 4310, Package DI M84943100, Package DI Number M84943101; Catalog Number 4320, Package DI M84943200, Package DI Number M84943201; Lot Numbers: H12-16-112 H12-16-113 H12-16-114 H01-17-002 H01-17-003 H01-17-004 H01-17-005 H01-17-101 H01-17-134 H01-17-135 H01-17-136 H02-17-044 H02-17-045 H02-17-046 H02-17-047 H02-17-048 H03-17-113 H03-17-114 H03-17-115 H03-17-116 H03-17-117 H03-17-233 H03-17-234 H03-17-235 H03-17-236 H03-17-237 H03-17-238 H05-17-119 H05-17-120 H05-17-121 H05-17-122 H05-17-123 H05-17-124 H06-17-142 H06-17-143 H06-17-144 H06-17-145 H07-17-112 H07-17-113 H07-17-114 H07-17-115 H08-17-127 H08-17-128 H08-17-129 H08-17-130 H08-17-131 H08-17-269 H08-17-270 H08-17-271 H08-17-272 H08-17-273 H09-17-102 H09-17-103 H09-17-104 H10-17-053 H10-17-056 H10-17-057 H10-17-058 H10-17-059 H10-17-060 H10-17-061 H11-17-146 H11-17-147 H11-17-148 H11-17-149 H11-17-150 H11-17-151 H12-17-120 H12-17-121 H12-17-122 H12-17-123 H12-17-124 H02-18-001 H02-18-002 H02-18-003 H02-18-004 H02-18-005 H02-18-209 H02-18-210 H02-18-211 H02-18-212 H02-18-219 H02-18-220 H02-18-221 H03-18-176 H03-18-177 H03-18-178 H03-18-179 H03-18-180 H04-18-038 H04-18-039 H04-18-040 H04-18-151 H04-18-152 H04-18-153 H04-18-154 H04-18-155 H04-18-156 H04-18-157 H05-18-177 H05-18-178 H05-18-179 H05-18-180 H06-18-111 H06-18-112 H06-18-113 H06-18-114 H07-18-017 H07-18-018 H07-18-019 H07-18-021 H07-18-020 H08-18-070 H08-18-071 H08-18-073 H08-18-072 H08-18-206 H08-18-207 H08-18-208 H10-18-117 H10-18-118 H10-18-120 H10-18-121 H10-18-119 H11-18-133 H11-18-134 H11-18-135 H11-18-136 H11-18-137 H01-19-023 H01-19-024 H01-19-025 H01-19-026 H01-19-027 H12-18-086 H12-18-087 H12-18-088 H12-18-089 H12-18-090 H01-19-178 H01-19-179 H01-19-180 H01-19-181 H01-19-182 H01-19-183 H02-19-184 H02-19-185 H02-19-186 H02-19-187 H02-19-188 H02-19-189 H02-19-190 H04-19-067 H04-19-068…
FDA’s list runs to 5,319 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 28, 2021.
- FDA classified it on Mar 2, 2022.
- FDA’s Enforcement Report published it on Mar 9, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Hobbs Medical, Inc., of Stafford Springs, CT.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,319 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.