Facility

HOBBS MEDICAL, INC.

5 recall(s) on record — most severe on record: Class II.

Key facts

5recalls · worst Class II

3inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1220592
Establishment type	Manufacture Medical Device
Location	8 Spring St Stafford Springs, CT, US 06076
Registration status	Active · expires 2026
Parent company	Hobbs Medical Inc (owner-operator 1220592)
Brand names	Microbiology Brush

Activity by year

Recalls (5)
Inspections (3)

Devices registered here (1)

Endoscopic Cytology Brush
Product code FDX (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1500

Recalls & enforcement

Class IIOngoing2024-10-04
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Class IIOngoing2022-07-29
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits contain…
Class IIOngoing2022-06-03
During use, the sheath of the device may accordion at the proximal end where the sheath meets the shrink band. Kinking of the sheath may prevent the snare from fully closing, and injury may result.
Class IIOngoing2021-12-28
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.
Class IITerminated2018-05-01
Device was marketed for uses outside the 510(k) clearance.

FDA inspections (3)

NAI2021-08-27
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2019-01-29
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2017-06-23
Voluntary Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Hobbs Medical Inc

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “HOBBS MEDICAL, INC. (FEI 1220592) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1220592-hobbs-medical-inc/

Not open yet

Alerts for HOBBS MEDICAL, INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.