FDA Medical Device Recalls (openFDA)
Hobbs Medical, Inc.: Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis.
- Recall number
- Z-2052-2018
- Recalling firm
- Hobbs Medical, Inc.
- Product
- Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis.
- Status
- Terminated
- Initiated
- 2018-05-01
- Posted
- not on file
- Terminated
- 2020-04-10
- Reason
- Device was marketed for uses outside the 510(k) clearance.
- Root cause
- Labeling False and Misleading
- Action
- The firm, Hobbs Medical, Inc., sent an "Voluntary Medical Device Recall Advisory Notice" letter to customers on 5/1/18. The letter described the product, problem and actions to be taken. Our records indicate that you have received the following Bronchial Cytology Brushes since the beginning of 2018: Please complete the quantity used and quantity returned section of the attached form and you may voluntarily return any unused device(s) referencing Return Authorization Number. Hobbs Medical will credit your account in a timely fashion. f you have any questions, please contact customer service at 800-344-6227.
- Quantity
- 1820 devices
- Distribution
- US Nationwide Distribution to states of: AZ, CA, GA, IL, MD, NY, TN, TX, and VA.
- Lot, serial or model codes
- H07-17-157 H12-17-004 H10-17-055 H12-17-062 H11-17-101 H12-17-062 H11-17-119 H12-17-064 H11-17-120 H12-17-064 H11-17-121 H12-17-065 H11-17-122 H12-17-066 H11-17-123 H12-17-067 H11-17-124 H01-18-095 H11-17-125 H01-18-096 H11-17-126 H01-18-097 H11-17-127 H01-18-097 H11-17-128 H01-18-098 H11-17-129 H01-18-098 H11-17-130 H01-18-098 H12-17-002 H01-18-099 H12-17-003 H01-18-100 H12-17-003 H01-18-101 H01-18-102
- 510(k) numbers
- ["K834402"]
- PMA numbers
- not on file
- Product code
- FDX
- Firm FEI
- 1220592
- Firm city
- Stafford Springs
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28