Z-2052-2018Class II

Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or...

Name: Z-2052-2018 Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or...
Creator: Hobbs Medical, Inc.
Published: 2018-05-01
License: https://open.fda.gov/license/

Hobbs Medical, Inc. / initiated 2018-05-01 / Terminated / root cause: labeling and UDI

FDA source

Hobbs Medical, Inc. began a recall of Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope... on 2018-05-01. FDA classified it as Class II and gives the reason as "Device was marketed for uses outside the 510(k) clearance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2052-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-01
Posted: 2018-06-01
Terminated: 2020-04-10
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.
Product code: FDX Endoscopic Cytology Brush
Reason for recall: Device was marketed for uses outside the 510(k) clearance.
Root cause tag: labeling and UDI
FDA 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 in commerce: 1820 devices
Distribution: US Nationwide Distribution to states of: AZ, CA, GA, IL, MD, NY, TN, TX, and VA.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2052-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2052-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-01

Product code FDX

K834402Class IIGastrointestinal Sheath BrushHobbs Medical, Inc. / cleared 1984-02-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)