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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Hobbs Medical, Inc.: 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.)

Agency Publication Date: October 7, 2022
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Affected Products

Product: Hobbs Biliary Pigtail Stent Kits Catalog Number: 6108

UDI-DI:M84961080 Lot Numbers: H02-18-254R

Lot Numbers:
Numbers
Product: Freeman Pancreatic Flexi-Stent Kit (containing 6352) Catalog Number: 6321

UDI-DI:M84963210 Lot Numbers: H08-18-064 H08-18-116 H08-18-194

Lot Numbers:
Numbers
Product: Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6351

UDI-DI:M84963510 Lot Numbers: H12-16-175R

Lot Numbers:
Numbers
Product: Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6352

UDI-DI: M84963520 Lot Numbers: H04-18-014R

Lot Numbers:
Numbers
Product: Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501

UDI-DI: M84965010 Lot Numbers: H09-18-008

Lot Numbers:
Numbers
Product: Freeman Pancreatic Flexi-Stent Kits: Single Pigtail (containing 6544) Catalog Number: 6503

UDI-DI: M84965030 Lot Numbers: H05-20-155 H06-20-022

Lot Numbers:
Numbers
Product: Freeman Pancreatic Flexi-Stent Kit (containing 6533) Catalog Number: 6507

UDI-DI: M84965070 Lot Numbers: H08-18-075

Lot Numbers:
Numbers
Product: Freeman Pancreatic Flexi-Stent Kit (containing 6566) Catalog Number: 6518

UDI-DI: M84965180 Lot Numbers: H08-18-118 H08-18-212

Lot Numbers:
Numbers
Product: Freeman Pancreatic Flexi-Stent Kit (containing 6567) Catalog Number: 6519

UDI-DI: M84965190 Lot Numbers: H08-18-119 H08-18-191

Lot Numbers:
Numbers
Product: Freeman Pancreatic Flexi-Stent Kit (containing 6568) Catalog Number: 6529

UDI-DI: M84965290 Lot Numbers: H08-18-117 H08-18-192

Lot Numbers:
Numbers
Product: Freeman Pancreatic Flexi-Stent Catalog Number: 6533

UDI-DI: M84965330 Lot Numbers: H08-17-085R

Lot Numbers:
Numbers
Product: Freeman Pancreatic Flexi-Stent Catalog Number: 6534

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

Lot Numbers:
Numbers
Product: Freeman Pancreatic Flexi-Stent Catalog Number: 6535

UDI-DI: M84965350 Lot Numbers: H01-16-055R

Lot Numbers:
Numbers
Product: Freeman Pancreatic Flexi-Stent Catalog Number: 6544

UDI-DI: 84965410 Lot Numbers: H01-20-254R

Lot Numbers:
Numbers
Product: Freeman Pancreatic Flexi-Stent Catalog Number: 6548

UDI-DI: M84965480 Lot Numbers: H06-17-182R

Lot Numbers:
Numbers
Product: Freeman Pancreatic Flexi-Stent Catalog Number: 6562

UDI-DI: M84965620 Lot Numbers: H02-18-260R

Lot Numbers:
Numbers
Product: Freeman Pancreatic Flexi-Stent Catalog Number: 6566

UDI-DI: M84965660 Lot Numbers: H01-18-204R

Lot Numbers:
Numbers
Product: Freeman Pancreatic Flexi-Stent Catalog Number: 6567

UDI-DI: M84965670 Lot Numbers: H02-18-262R

Lot Numbers:
Numbers
Product: Freeman Pancreatic Flexi-Stent Catalog Number: 6568

UDI-DI: M84965680 Lot Numbers: H12-17-203R

Lot Numbers:
Numbers
Product: Freeman Pancreatic Flexi-Stent Catalog Number: 6582

UDI-DI: M84965820 Lot Numbers: H07-16-033R

Lot Numbers:
Numbers
Product: Freeman Pancreatic Flexi-Stent Catalog Number: 6584

UDI-DI: M84965840 Lot Numbers: H07-16-033R

Lot Numbers:
Numbers
Product: Freeman Pancreatic Flexi-Stent (contained in kit 6501) Catalog Number: 6541

UDI-DI: M84965840 Lot Numbers: H07-16-033R Kit Lot Number: H09-18-008

Lot Numbers:
Numbers
Number
Product: Hobbs Medical Polypectomy Snare Catalog Number: 7202

UDI-DI: M84972020 Lot Numbers: H10-17-089R H08-17-014R

Lot Numbers:
Numbers
Product: Hobbs Medical Polypectomy Snare Catalog Number: 4563-OLY

UDI-DI: M8494563OLY0 Lot Numbers: H03-18-137R

Lot Numbers:
Numbers
Product: Hobbs Medical Polypectomy Snare Catalog Number: 4565-OLY

UDI-DI: M8494565OLY0 Lot Numbers: H02-18-111R H04-18-063R

Lot Numbers:
Numbers
Product: Hobbs Medical Polypectomy Snare Catalog Number: 4575-OLY

UDI-DI: M8494575OLY0 Lot Numbers: H01-16-117R

Lot Numbers:
Numbers
Product: Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190

UD-DI: M84921900 Lot Numbers: H02-18-166R H02-18-167R H02-18-168R H02-18-169R H04-18-214R H11-17-182R

Lot Numbers:
Numbers
Product: Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191

UDI-DI: M84921910 Lot Numbers: H03-16-015R

Lot Numbers:
Numbers
Product: Hobbs Medical Flex-Ez Guide Wire Disposable For endoscopy procedures Ref: 3412

UD-DI: M84934120 Lot Numbers: H05-18-091R

Lot Numbers:
Numbers
Product: Hobbs Medical Cytology Brush Catalog Number: 4204

UDI-DI: M84942040 Lot Numbers: H10-19-001R H12-19-050R H12-19-051R

Lot Numbers:
Numbers
Product: Hobbs Medical Cytology Brush Catalog Number: 4206

UDI-DI:M84942060 Lot Numbers: H01-20-179R H01-20-181R H01-20-182R

Lot Numbers:
Numbers
Product: Hobbs Medical Polypectomy Snare Catalog Number: 4563

UDI-DI: M84945630 Lot Numbers: H03-16-067R H09-15-146R H10-15-086R H12-15-100R

Lot Numbers:
Numbers
Product: Hobbs Medical Polypectomy Snare Catalog Number: 4564

UDI-DI: M84945640 Lot Numbers: H02-18-198R H09-17-027R

Lot Numbers:
Numbers
Product: Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620

UDI-DI: M84946200 Lot Numbers: H06-17-090R

Lot Numbers:
Numbers
Product: Hobbs Transbronchial Aspiration Needle Catalog Number: 4621

UDI-DI:M84946210 Lot Numbers: H04-17-039R

Lot Numbers:
Numbers
Product: Hobbs Scope Introducer Catalog Number: 4650

UDI-DI: M84946500 Lot Numbers: H04-18-182R H04-18-181R

Lot Numbers:
Numbers
Product: Hobbs Posi-Stop Injection Needle Catalog Number: 4702

UDI-DI:M84947020 Lot Numbers: H10-17-062R H10-17-062R

Lot Numbers:
Numbers
Product: Hobbs Posi-Stop Injection Needle Catalog Number: 4704

UDI-DI: M84947040 Lot Numbers: H01-17-198R

Lot Numbers:
Numbers
Product: Hobbs Posi-Stop Injection Needle Catalog Number: 4712

UDI-DI: M84947120 Lot Numbers: H04-15-157R

Lot Numbers:
Numbers
Product: Hobbs Posi-Stop Injection Needle Catalog Number: 4718

UDI-DI: M84947180 Lot Numbers: H11-17-176R

Lot Numbers:
Numbers
Product: Hobbs Posi-Stop Injection Needle Catalog Number: 4720

UDI-DI:M84947200 Lot Numbers: H03-18-152R

Lot Numbers:
Numbers
Product: Hobbs Posi-Stop Injection Needle Catalog Number: 4722

UDI-DI:M84947220 Lot Numbers: H06-18-046R

Lot Numbers:
Numbers
Product: Hobbs Helical Retrieval Basket Catalog Number: 4806

UDI-DI: M84948060 Lot Numbers: H02-18-112R

Lot Numbers:
Numbers
Product: Hobbs Helical Retrieval Basket Catalog Number: 4808

UDI-DI: M84948080 Lot Numbers: H02-18-113R

Lot Numbers:
Numbers
Product: Hobbs Helical Retrieval Basket Catalog Number: 4814

UDI-DI: M84948140 Lot Numbers: H10-17-098R

Lot Numbers:
Numbers
Product: Hobbs Helical Retrieval Basket Catalog Number: 4816

UDI-DI: M84948160 Lot Numbers: H03-18-168R

Lot Numbers:
Numbers
Product: Hobbs Helical Retrieval Basket Catalog Number: 4822

UDI-DI: M84948220 Lot Numbers: H11-17-161R H02-17-102R

Lot Numbers:
Numbers
Product: Hobbs Helical Retrieval Basket Catalog Number: 4824

UDI-DI: M84948240 Lot Numbers: H02-17-159R

Lot Numbers:
Numbers
Product: Hobbs Helical Retrieval Basket Catalog Number: 4830

UDI-DI: M84948300 Lot Numbers: H10-16-021R

Lot Numbers:
Numbers
Product: Hobbs Helical Retrieval Basket Catalog Number: 4832

UDI-DI: M84948320 Lot Numbers: H11-17-162R H01-17-137R

Lot Numbers:
Numbers
Product: Hobbs Medical Grasping Forceps Catalog Number:5004

UDI-DI: M84950040 Lot Numbers: H01-17-090R

Lot Numbers:
Numbers
Product: Hobbs Medical Grasping Forceps Catalog Number: 5008

UDI-DI: M84950080 Lot Numbers: H10-17-211R H09-17-086R

Lot Numbers:
Numbers
Product: Hobbs Retrieval Forceps Catalog Number: 5018

UDI-DI: M84950180 Lot Numbers: H06-15-180R

Lot Numbers:
Numbers
Product: Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001

UDI-DI: M84960010 Lot Numbers: H01-19-234 H01-19-230

Lot Numbers:
Numbers
Product: Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004

UDI-DI: M84960040 Lot Numbers: H02-19-022

Lot Numbers:
Numbers
Product: Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023

UDI-DI: M84960230 Lot Numbers: H02-19-019 H10-18-183

Lot Numbers:
Numbers
Product: Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024

UDI-DI: M84960240 Lot Numbers: H02-19-023 H11-18-188

Lot Numbers:
Numbers
Product: Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027

UDI-DI: M84960270 Lot Numbers: H01-19-241

Lot Numbers:
Numbers
Product: Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028

UDI-DI: M84960280 Lot Numbers: H02-19-021

Lot Numbers:
Numbers
Product: Hobbs Biliary Pigtail Stent Kits Catalog Number: 6104

UDI-DI: M84961040 Lot Numbers: H11-17-020R

Lot Numbers:
Numbers
Product: Hobbs Biliary Pigtail Stent Kits Catalog Number: 6105

UDI-DI: M84961050 Lot Numbers: H10-17-031R

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90769
Status: Active
Manufacturer: Hobbs Medical, Inc.
Manufactured In: United States
Units Affected: 60 products (275 units; 30 units; 32 units; 300 units; 300 units; 100 units; 35 units; 18 units; 7 units; 140 units; 8 units; 7 units; 6 units; 30 units; 50 units; 17 units; 4 units; 2 units; 3 units; 10 units; 14 units; 10 units; 7 units; 13 units; 3 units; 14 units; 4 units; 3 units; 2 units; 3 units; 3 units; 3 units; 15 units; 7 units; 16 units; 6 units; 8 units; 14 units; 10 units; 3 units; 4 units; 2 units; 4 units; 4 units; 6 units; 10 units; 13 units; 27 units; 10 units; 30 units; 8 units; 6 units; 6 units; 4 units; 4 units; 1 unit; 20 units; 30 units; 10 units; 10 units)
Agency Last Updated: October 18, 2022

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.