Recall Register

Food, drugs, devices › Hobbs Medical, Inc.

Device recall: Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190

FDA enforcement event 90769 · Class II · initiated 29 Jul 2022 · status Ongoing

DeviceVoluntary: Firm initiated61 product recordsStafford Springs, CT

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 numberProductQuantityClassStatusReport date
Z-0010-2023Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190275 unitsClass IIOngoing19 Oct 2022
Z-0011-2023Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 219130 unitsClass IIOngoing19 Oct 2022
Z-0012-2023Hobbs Medical Flex-Ez Guide Wire Disposable For endoscopy procedures Ref: 341232 unitsClass IIOngoing19 Oct 2022
Z-0013-2023Hobbs Medical Cytology Brush Catalog Number: 4204300 unitsClass IIOngoing19 Oct 2022
Z-0014-2023Hobbs Medical Cytology Brush Catalog Number: 4206300 unitsClass IIOngoing19 Oct 2022
Z-0015-2023Hobbs Medical Polypectomy Snare Catalog Number: 4563100 unitsClass IIOngoing19 Oct 2022
Z-0016-2023Hobbs Medical Polypectomy Snare Catalog Number: 456435 unitsClass IIOngoing19 Oct 2022
Z-0017-2023Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 462018 unitsClass IIOngoing19 Oct 2022
Z-0018-2023Hobbs Transbronchial Aspiration Needle Catalog Number: 46217 unitsClass IIOngoing19 Oct 2022
Z-0019-2023Hobbs Scope Introducer Catalog Number: 4650140 unitsClass IIOngoing19 Oct 2022
Z-0020-2023Hobbs Posi-Stop Injection Needle Catalog Number: 47028 unitsClass IIOngoing19 Oct 2022
Z-0021-2023Hobbs Posi-Stop Injection Needle Catalog Number: 47047 unitsClass IIOngoing19 Oct 2022
Z-0022-2023Hobbs Posi-Stop Injection Needle Catalog Number: 47126 unitsClass IIOngoing19 Oct 2022
Z-0023-2023Hobbs Posi-Stop Injection Needle Catalog Number: 471830 unitsClass IIOngoing19 Oct 2022
Z-0024-2023Hobbs Posi-Stop Injection Needle Catalog Number: 472050 unitsClass IIOngoing19 Oct 2022
Z-0025-2023Hobbs Posi-Stop Injection Needle Catalog Number: 472217 unitsClass IIOngoing19 Oct 2022
Z-0026-2023Hobbs Helical Retrieval Basket Catalog Number: 48064 unitsClass IIOngoing19 Oct 2022
Z-0027-2023Hobbs Helical Retrieval Basket Catalog Number: 48082 unitsClass IIOngoing19 Oct 2022
Z-0028-2023Hobbs Helical Retrieval Basket Catalog Number: 48143 unitsClass IIOngoing19 Oct 2022
Z-0029-2023Hobbs Helical Retrieval Basket Catalog Number: 481610 unitsClass IIOngoing19 Oct 2022
Z-0030-2023Hobbs Helical Retrieval Basket Catalog Number: 482214 unitsClass IIOngoing19 Oct 2022
Z-0031-2023Hobbs Helical Retrieval Basket Catalog Number: 482410 unitsClass IIOngoing19 Oct 2022
Z-0032-2023Hobbs Helical Retrieval Basket Catalog Number: 48307 unitsClass IIOngoing19 Oct 2022
Z-0033-2023Hobbs Helical Retrieval Basket Catalog Number: 483213 unitsClass IIOngoing19 Oct 2022
Z-0034-2023Hobbs Medical Grasping Forceps Catalog Number:50043 unitsClass IIOngoing19 Oct 2022
Z-0035-2023Hobbs Medical Grasping Forceps Catalog Number: 500814 unitsClass IIOngoing19 Oct 2022
Z-0036-2023Hobbs Retrieval Forceps Catalog Number: 50184 unitsClass IIOngoing19 Oct 2022
Z-0037-2023Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 60013 unitsClass IIOngoing19 Oct 2022
Z-0038-2023Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:60042 unitsClass IIOngoing19 Oct 2022
Z-0039-2023Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 60233 unitsClass IIOngoing19 Oct 2022
Z-0040-2023Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 60243 unitsClass IIOngoing19 Oct 2022
Z-0041-2023Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027N/AClass IIOngoing19 Oct 2022
Z-0042-2023Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 60283 unitsClass IIOngoing19 Oct 2022
Z-0043-2023Hobbs Biliary Pigtail Stent Kits Catalog Number: 610415 unitsClass IIOngoing19 Oct 2022
Z-0044-2023Hobbs Biliary Pigtail Stent Kits Catalog Number: 61057 unitsClass IIOngoing19 Oct 2022
Z-0045-2023Hobbs Biliary Pigtail Stent Kits Catalog Number: 610816 unitsClass IIOngoing19 Oct 2022
Z-0046-2023Freeman Pancreatic Flexi-Stent Kit (containing 6352) Catalog Number: 63216 unitsClass IIOngoing19 Oct 2022
Z-0047-2023Freeman Pancreatic Flexi-Stent Kit Catalog Number: 63518 unitsClass IIOngoing19 Oct 2022
Z-0048-2023Freeman Pancreatic Flexi-Stent Kit Catalog Number: 635214 unitsClass IIOngoing19 Oct 2022
Z-0049-2023Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 650110 unitsClass IIOngoing19 Oct 2022
Z-0050-2023Freeman Pancreatic Flexi-Stent Kits: Single Pigtail (containing 6544) Catalog Number: 65033 unitsClass IIOngoing19 Oct 2022
Z-0051-2023Freeman Pancreatic Flexi-Stent Kit (containing 6533) Catalog Number: 65074 unitsClass IIOngoing19 Oct 2022
Z-0052-2023Freeman Pancreatic Flexi-Stent Kit (containing 6566) Catalog Number: 65182 unitsClass IIOngoing19 Oct 2022
Z-0053-2023Freeman Pancreatic Flexi-Stent Kit (containing 6567) Catalog Number: 65194 unitsClass IIOngoing19 Oct 2022
Z-0054-2023Freeman Pancreatic Flexi-Stent Kit (containing 6568) Catalog Number: 65294 unitsClass IIOngoing19 Oct 2022
Z-0055-2023Freeman Pancreatic Flexi-Stent Catalog Number: 65336 unitsClass IIOngoing19 Oct 2022
Z-0056-2023Freeman Pancreatic Flexi-Stent Catalog Number: 653410 unitsClass IIOngoing19 Oct 2022
Z-0057-2023Freeman Pancreatic Flexi-Stent Catalog Number: 653513 unitsClass IIOngoing19 Oct 2022
Z-0058-2023Freeman Pancreatic Flexi-Stent Catalog Number: 654427 unitsClass IIOngoing19 Oct 2022
Z-0059-2023Freeman Pancreatic Flexi-Stent Catalog Number: 654810 unitsClass IIOngoing19 Oct 2022
Z-0060-2023Freeman Pancreatic Flexi-Stent Catalog Number: 656230 unitsClass IIOngoing19 Oct 2022
Z-0061-2023Freeman Pancreatic Flexi-Stent Catalog Number: 65668 unitsClass IIOngoing19 Oct 2022
Z-0062-2023Freeman Pancreatic Flexi-Stent Catalog Number: 65676 unitsClass IIOngoing19 Oct 2022
Z-0063-2023Freeman Pancreatic Flexi-Stent Catalog Number: 65686 unitsClass IIOngoing19 Oct 2022
Z-0064-2023Freeman Pancreatic Flexi-Stent Catalog Number: 65824 unitsClass IIOngoing19 Oct 2022
Z-0065-2023Freeman Pancreatic Flexi-Stent Catalog Number: 65844 unitsClass IIOngoing19 Oct 2022
Z-0066-2023Freeman Pancreatic Flexi-Stent (contained in kit 6501) Catalog Number: 65411 unitClass IIOngoing19 Oct 2022
Z-0067-2023Hobbs Medical Polypectomy Snare Catalog Number: 720220 unitsClass IIOngoing19 Oct 2022
Z-0068-2023Hobbs Medical Polypectomy Snare Catalog Number: 4563-OLY30 unitsClass IIOngoing19 Oct 2022
Z-0069-2023Hobbs Medical Polypectomy Snare Catalog Number: 4565-OLY10 unitsClass IIOngoing19 Oct 2022

Showing 60 of 61 product records; the FDA enforcement report lists all of them.

Context

88%of 2022 device events are Class II839 events that year
61product records in this eventfirm median: 1
5events on this register for the firm

Other enforcement events for Hobbs Medical, Inc.

InitiatedProduct (first record)TypeClassRecords
4 Oct 2024Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720DeviceClass II9
3 Jun 2022Hobbs Medical Polypectomy Snare, Catalog No. 7202DeviceClass II1
28 Dec 2021Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as tDeviceClass II1
1 May 2018Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained perDeviceClass II1

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.