Food, drugs, devices › Hobbs Medical, Inc.
Device recall: Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Hobbs Medical, Inc. (Stafford Springs, CT) initiated this device recall on 29 Jul 2022; FDA lists 61 product records under event 90769, classified Class II.
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. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. 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 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 containing at least 1 device with a lot number ending in R.)"
Distribution
"Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0010-2023 | Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190 | 275 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0011-2023 | Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191 | 30 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0012-2023 | Hobbs Medical Flex-Ez Guide Wire Disposable For endoscopy procedures Ref: 3412 | 32 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0013-2023 | Hobbs Medical Cytology Brush Catalog Number: 4204 | 300 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0014-2023 | Hobbs Medical Cytology Brush Catalog Number: 4206 | 300 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0015-2023 | Hobbs Medical Polypectomy Snare Catalog Number: 4563 | 100 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0016-2023 | Hobbs Medical Polypectomy Snare Catalog Number: 4564 | 35 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0017-2023 | Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620 | 18 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0018-2023 | Hobbs Transbronchial Aspiration Needle Catalog Number: 4621 | 7 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0019-2023 | Hobbs Scope Introducer Catalog Number: 4650 | 140 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0020-2023 | Hobbs Posi-Stop Injection Needle Catalog Number: 4702 | 8 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0021-2023 | Hobbs Posi-Stop Injection Needle Catalog Number: 4704 | 7 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0022-2023 | Hobbs Posi-Stop Injection Needle Catalog Number: 4712 | 6 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0023-2023 | Hobbs Posi-Stop Injection Needle Catalog Number: 4718 | 30 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0024-2023 | Hobbs Posi-Stop Injection Needle Catalog Number: 4720 | 50 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0025-2023 | Hobbs Posi-Stop Injection Needle Catalog Number: 4722 | 17 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0026-2023 | Hobbs Helical Retrieval Basket Catalog Number: 4806 | 4 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0027-2023 | Hobbs Helical Retrieval Basket Catalog Number: 4808 | 2 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0028-2023 | Hobbs Helical Retrieval Basket Catalog Number: 4814 | 3 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0029-2023 | Hobbs Helical Retrieval Basket Catalog Number: 4816 | 10 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0030-2023 | Hobbs Helical Retrieval Basket Catalog Number: 4822 | 14 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0031-2023 | Hobbs Helical Retrieval Basket Catalog Number: 4824 | 10 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0032-2023 | Hobbs Helical Retrieval Basket Catalog Number: 4830 | 7 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0033-2023 | Hobbs Helical Retrieval Basket Catalog Number: 4832 | 13 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0034-2023 | Hobbs Medical Grasping Forceps Catalog Number:5004 | 3 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0035-2023 | Hobbs Medical Grasping Forceps Catalog Number: 5008 | 14 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0036-2023 | Hobbs Retrieval Forceps Catalog Number: 5018 | 4 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0037-2023 | Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001 | 3 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0038-2023 | Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004 | 2 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0039-2023 | Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023 | 3 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0040-2023 | Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024 | 3 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0041-2023 | Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027 | N/A | Class II | Ongoing | 19 Oct 2022 |
| Z-0042-2023 | Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028 | 3 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0043-2023 | Hobbs Biliary Pigtail Stent Kits Catalog Number: 6104 | 15 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0044-2023 | Hobbs Biliary Pigtail Stent Kits Catalog Number: 6105 | 7 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0045-2023 | Hobbs Biliary Pigtail Stent Kits Catalog Number: 6108 | 16 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0046-2023 | Freeman Pancreatic Flexi-Stent Kit (containing 6352) Catalog Number: 6321 | 6 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0047-2023 | Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6351 | 8 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0048-2023 | Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6352 | 14 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0049-2023 | Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501 | 10 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0050-2023 | Freeman Pancreatic Flexi-Stent Kits: Single Pigtail (containing 6544) Catalog Number: 6503 | 3 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0051-2023 | Freeman Pancreatic Flexi-Stent Kit (containing 6533) Catalog Number: 6507 | 4 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0052-2023 | Freeman Pancreatic Flexi-Stent Kit (containing 6566) Catalog Number: 6518 | 2 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0053-2023 | Freeman Pancreatic Flexi-Stent Kit (containing 6567) Catalog Number: 6519 | 4 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0054-2023 | Freeman Pancreatic Flexi-Stent Kit (containing 6568) Catalog Number: 6529 | 4 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0055-2023 | Freeman Pancreatic Flexi-Stent Catalog Number: 6533 | 6 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0056-2023 | Freeman Pancreatic Flexi-Stent Catalog Number: 6534 | 10 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0057-2023 | Freeman Pancreatic Flexi-Stent Catalog Number: 6535 | 13 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0058-2023 | Freeman Pancreatic Flexi-Stent Catalog Number: 6544 | 27 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0059-2023 | Freeman Pancreatic Flexi-Stent Catalog Number: 6548 | 10 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0060-2023 | Freeman Pancreatic Flexi-Stent Catalog Number: 6562 | 30 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0061-2023 | Freeman Pancreatic Flexi-Stent Catalog Number: 6566 | 8 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0062-2023 | Freeman Pancreatic Flexi-Stent Catalog Number: 6567 | 6 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0063-2023 | Freeman Pancreatic Flexi-Stent Catalog Number: 6568 | 6 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0064-2023 | Freeman Pancreatic Flexi-Stent Catalog Number: 6582 | 4 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0065-2023 | Freeman Pancreatic Flexi-Stent Catalog Number: 6584 | 4 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0066-2023 | Freeman Pancreatic Flexi-Stent (contained in kit 6501) Catalog Number: 6541 | 1 unit | Class II | Ongoing | 19 Oct 2022 |
| Z-0067-2023 | Hobbs Medical Polypectomy Snare Catalog Number: 7202 | 20 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0068-2023 | Hobbs Medical Polypectomy Snare Catalog Number: 4563-OLY | 30 units | Class II | Ongoing | 19 Oct 2022 |
| Z-0069-2023 | Hobbs Medical Polypectomy Snare Catalog Number: 4565-OLY | 10 units | Class II | Ongoing | 19 Oct 2022 |
Showing 60 of 61 product records; the FDA enforcement report lists all of them.
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 |
| 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 |
| 1 May 2018 | Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained per | 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 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 containing at least 1 device with a lot number ending in R.)"
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: "Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway."
Is the recall still ongoing?
FDA lists the status as Ongoing. "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.