CLASS II ONGOING Device recall · Reported 19 Oct 2022 · FDA Enforcement Report

Freeman Pancreatic Flexi-Stent recalled by Hobbs Medical

Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent, distributed nationwide in the US. The recall was initiated on 29 Jul 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: M84965340 Lot Numbers: H11-17-025R

Quantity recalled10 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0056-2023
FDA event ID: 90769
Recalling firm: Hobbs Medical, Stafford Springs, CT
Classification: Class II
Status: Ongoing
Recall initiated: 29 Jul 2022
FDA classified: 7 Oct 2022
Reported: 19 Oct 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

29 Jul 2022	Recall initiated by company
7 Oct 2022	Classified by FDA	+70 days
19 Oct 2022	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.)

Product as listed by the FDA

Freeman Pancreatic Flexi-Stent Catalog Number: 6534

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI: M84965340 Lot Numbers: H11-17-025R

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

60 other products · FDA event 90769

This product is part of a recall event; the main page for the event is Polypectomy Snare recalled by Hobbs Medical.

Reported	Class	Recall	Company	Reason	Where
19 Oct 2022	CLASS II	Polypectomy Snare recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Freeman Pancreatic Flexi-Stent Kit (containing 6533) recalled	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Freeman Pancreatic Flexi-Stent Kits: Single Pigtail recalled	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Transbronchial Aspiration Needle recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Posi-Stop Injection Needle recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Grasping Forceps recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Polypectomy Snare recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Freeman Pancreatic Flexi-Stent Kit (containing 6568) recalled	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Biliary Pigtail Stent Kits (contains 3412) recalled	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Cytology Brush recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Freeman Pancreatic Flexi-Stent recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Helical Retrieval Basket recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Cytology Brush recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Helical Retrieval Basket recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Freeman Pancreatic Flexi-Stent Kit (containing 6352) recalled	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Freeman Pancreatic Flexi-Stent recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Helical Retrieval Basket recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Posi-Stop Injection Needle recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Spray Catheter: The Mistifier: Disposable For endoscopy procedures recalled	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Posi-Stop Injection Needle recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Freeman Pancreatic Flexi-Stent recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Biliary Pigtail Stent Kits recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Freeman Pancreatic Flexi-Stent recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Helical Retrieval Basket recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Freeman Pancreatic Flexi-Stent recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Freeman Pancreatic Flexi-Stent recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Freeman Pancreatic Flexi-Stent (contained in kit 6501) recalled	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Transbronchial Aspiration Needle recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Freeman Pancreatic Flexi-Stent recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Helical Retrieval Basket recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Biliary Pigtail Stent Kits (containing 3412) recalled	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Spray Catheter: The Mistifier: Disposable For endoscopy procedures recalled	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Freeman Pancreatic Flexi-Stent recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Helical Retrieval Basket recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Posi-Stop Injection Needle recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Biliary Pigtail Stent Kits recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Freeman Pancreatic Flexi-Stent Kit (containing 6567) recalled	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Polypectomy Snare recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Freeman Pancreatic Flexi-Stent Kit (containing 6566) recalled	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Grasping Forceps recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Helical Retrieval Basket recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Retrieval Forceps recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Polypectomy Snare recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Freeman Pancreatic Flexi-Stent Kit recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Freeman Pancreatic Flexi-Stent Kit recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Biliary Pigtail Stent Kits (containing 3412) recalled	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Freeman Pancreatic Flexi-Stent recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Scope Introducer recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Polypectomy Snare recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Biliary Pigtail Stent Kits (containing 3412) recalled	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Helical Retrieval Basket recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Biliary Pigtail Stent Kits recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Posi-Stop Injection Needle recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Freeman Pancreatic Flexi-Stent Kits: Single Pigtail recalled	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Biliary Pigtail Stent Kits (containing 6105) recalled	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Flex-Ez Guide Wire Disposable For endoscopy procedures recalled	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Polypectomy Snare recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Posi-Stop Injection Needle recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Freeman Pancreatic Flexi-Stent recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
19 Oct 2022	CLASS II	Hobbs Biliary Pigtail Stent Kits (containing 3412) recalled	Hobbs Medical	Other	Nationwide

More recalls from Hobbs Medical

All 73

Reported	Class	Recall	Company	Reason	Where
27 Nov 2024Device	CLASS II	Posi-Stop Injection Needle recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
27 Nov 2024Device	CLASS II	Posi-Stop Injection Needle recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
27 Nov 2024Device	CLASS II	Posi-Stop Injection Needle recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
27 Nov 2024Device	CLASS II	Posi-Stop Injection Needle recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide
27 Nov 2024Device	CLASS II	Posi-Stop Injection Needle recalled by Hobbs Medical	Hobbs Medical	Other	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide