Food, drugs, devices › Hobbs Medical, Inc.
Device recall: Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained per
FDA enforcement event 79903 is a device recall by Hobbs Medical, Inc. of Stafford Springs, CT, initiated 1 May 2018 and classified Class II, with 1 product record.
FDA defines Class II as 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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 10 Apr 2020. Initiation: voluntary: firm initiated. Hobbs Medical, Inc. has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Hobbs Medical, Inc., Stafford Springs, CT.
Reason for recall
"Device was marketed for uses outside the 510(k) clearance."
Distribution
"US Nationwide Distribution to states of: AZ, CA, GA, IL, MD, NY, TN, TX, and VA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2052-2018 | 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. | 1820 devices | Class II | Terminated | 13 Jun 2018 |
Context
Other enforcement events for Hobbs Medical, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Oct 2024 | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720 | Device | Class II | 9 |
| 29 Jul 2022 | Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190 | Device | Class II | 61 |
| 3 Jun 2022 | Hobbs Medical Polypectomy Snare, Catalog No. 7202 | Device | Class II | 1 |
| 28 Dec 2021 | Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as t | Device | Class II | 1 |
All 5 events for Hobbs Medical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Device was marketed for uses outside the 510(k) clearance."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution to states of: AZ, CA, GA, IL, MD, NY, TN, TX, and VA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 Apr 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.