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HOBBS MEDICAL, INC.

Last updated September 17, 2026

Information

Country: US
Address: 8 Spring St, Stafford Springs, CT, 06076
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1220592
DUNS Number: —

Catalogue (261)

Page 5 of 6

Device	Model / Reference	Registries	Class	Status
Freeman Pancreatic Flexi-Stent Kit	6526	FDA UDI	Class II	Active
Hobbs Microbiology Brush	4310	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6552	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6320	FDA UDI	Class II	Active
Flex-Ez Stylet Wire Balloon Dilator	3752	FDA UDI	Class II	Active
Hobbs Helical Retrieval Basket	4822	FDA UDI	Class II	Active
Flex-Ez Over the Wire Balloon Dilator	3264	FDA UDI	Class II	Active
Hobbs Posi-Stop Injection Needle	4702	FDA UDI	Class II	Active
Flex-Ez Over the Wire Balloon Dilator	3156	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6554	FDA UDI	Class II	Active
Hobbs Medical Cytology Brush	4204	FDA UDI	Class II	Active
Hobbs Medical TouchSoft Coagulator	G1120040	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6311	FDA UDI	Class II	Active
Hobbs Biliary Amsterdam Stent	6120	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6530	FDA UDI	Class II	Active
Hobbs Biliary Amsterdam Stent	6112	FDA UDI	Class II	Active
Hobbs Achalasia Dilation Balloon	3304	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent KIt	6510	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6544	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6561	FDA UDI	Class II	Active
Hobbs Biliary Pigtail Stent	6103	FDA UDI	Class II	Active
Hobbs Medical Grasping Forceps Handle	5050	FDA UDI	Class II	Active
Flex-Ez Over the Wire Balloon Dilator	3258	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6502	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6509	FDA UDI	Class II	Active
Hobbs Helical Retrieval Basket	4816	FDA UDI	Class II	Active
Flex-Ez Stylet Wire Balloon Dilator	3716	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6321	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6529	FDA UDI	Class II	Active
Hobbs Pusher Catheter	6134	FDA UDI	Class II	Active
Flex-Ez Stylet Wire Balloon Dilator	3710	FDA UDI	Class II	Active
Hobbs Biliary Pigtail Stent	6105	FDA UDI	Class II	Active
Hobbs Biliary Pigtail Stent	6102	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6572	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6352	FDA UDI	Class II	Active
Flex-Ez Stylet Wire Balloon Dilator	3754	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6508	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6547	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6532	FDA UDI	Class II	Active
Flex-Ez Stylet Wire Balloon Dilator	3762	FDA UDI	Class II	Active
Encapsulated Guidewire With Flexible Tip	K914358	FDA 510(k)	Class II	Active
Hobbs Medical Grasping Forceps	K833125	FDA 510(k)	Class II	Active
Dilation Balloon Catheter	K834413	FDA 510(k)	Class II	Active
Pressure Gauge	K921026	FDA 510(k)	Class II	Active
Hobbs Medical Retrieval Basket	K833124	FDA 510(k)	Class II	Active
Hobbs Medical Cleaning Brush	K933354	FDA 510(k)	Class II	Active
Hobbs Medical/Jayco Aspiration Catheter	K844550	FDA 510(k)	Class II	Active
Linden Stone Extraction Balloon	K872509	FDA 510(k)	Class II	Active
Touchsoft Coagulator With Banana Fitting, Model 4581 And With Universal Fitting, Model 4581-U	K093079	FDA 510(k)	Class II	Active
Hobbs Medical Polypectomy Snare	K844074	FDA 510(k)FDA UDI	Class II	Active

Related Companies

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FDA Recalls (74)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 4, 2024	Z-0469-2025	—	open, classified	Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Oct 4, 2024	Z-0474-2025	—	open, classified	Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Oct 4, 2024	Z-0476-2025	—	open, classified	Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Oct 4, 2024	Z-0472-2025	—	open, classified	Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Oct 4, 2024	Z-0468-2025	—	open, classified	Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Oct 4, 2024	Z-0473-2025	—	open, classified	Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Oct 4, 2024	Z-0475-2025	—	open, classified	Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Oct 4, 2024	Z-0471-2025	—	open, classified	Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Oct 4, 2024	Z-0470-2025	—	open, classified	Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Jul 29, 2022	Z-0035-2023	—	open, classified	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.)
Jul 29, 2022	Z-0016-2023	—	open, classified	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.)
Jul 29, 2022	Z-0068-2023	—	open, classified	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.)
Jul 29, 2022	Z-0042-2023	—	open, classified	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.)
Jul 29, 2022	Z-0029-2023	—	open, classified	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.)
Jul 29, 2022	Z-0052-2023	—	open, classified	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.)
Jul 29, 2022	Z-0024-2023	—	open, classified	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.)
Jul 29, 2022	Z-0030-2023	—	open, classified	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.)
Jul 29, 2022	Z-0015-2023	—	open, classified	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.)
Jul 29, 2022	Z-0028-2023	—	open, classified	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.)
Jul 29, 2022	Z-0063-2023	—	open, classified	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.)
Jul 29, 2022	Z-0027-2023	—	open, classified	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.)
Jul 29, 2022	Z-0031-2023	—	open, classified	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.)
Jul 29, 2022	Z-0058-2023	—	open, classified	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.)
Jul 29, 2022	Z-0054-2023	—	open, classified	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.)
Jul 29, 2022	Z-0050-2023	—	open, classified	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.)
Jul 29, 2022	Z-0060-2023	—	open, classified	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.)
Jul 29, 2022	Z-0037-2023	—	open, classified	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.)
Jul 29, 2022	Z-0026-2023	—	open, classified	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.)
Jul 29, 2022	Z-0055-2023	—	open, classified	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.)
Jul 29, 2022	Z-0023-2023	—	open, classified	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.)
Jul 29, 2022	Z-0047-2023	—	open, classified	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.)
Jul 29, 2022	Z-0025-2023	—	open, classified	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.)
Jul 29, 2022	Z-0010-2023	—	open, classified	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.)
Jul 29, 2022	Z-0059-2023	—	open, classified	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.)
Jul 29, 2022	Z-0040-2023	—	open, classified	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.)
Jul 29, 2022	Z-0039-2023	—	open, classified	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.)
Jul 29, 2022	Z-0013-2023	—	open, classified	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.)
Jul 29, 2022	Z-0044-2023	—	open, classified	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.)
Jul 29, 2022	Z-0038-2023	—	open, classified	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.)
Jul 29, 2022	Z-0048-2023	—	open, classified	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.)
Jul 29, 2022	Z-0018-2023	—	open, classified	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.)
Jul 29, 2022	Z-0057-2023	—	open, classified	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.)
Jul 29, 2022	Z-0036-2023	—	open, classified	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.)
Jul 29, 2022	Z-0070-2023	—	open, classified	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.)
Jul 29, 2022	Z-0014-2023	—	open, classified	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.)
Jul 29, 2022	Z-0032-2023	—	open, classified	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.)
Jul 29, 2022	Z-0021-2023	—	open, classified	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.)
Jul 29, 2022	Z-0043-2023	—	open, classified	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.)
Jul 29, 2022	Z-0066-2023	—	open, classified	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.)
Jul 29, 2022	Z-0067-2023	—	open, classified	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.)
Jul 29, 2022	Z-0064-2023	—	open, classified	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.)
Jul 29, 2022	Z-0011-2023	—	open, classified	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.)
Jul 29, 2022	Z-0061-2023	—	open, classified	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.)
Jul 29, 2022	Z-0051-2023	—	open, classified	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.)
Jul 29, 2022	Z-0069-2023	—	open, classified	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.)
Jul 29, 2022	Z-0034-2023	—	open, classified	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.)
Jul 29, 2022	Z-0041-2023	—	open, classified	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.)
Jul 29, 2022	Z-0062-2023	—	open, classified	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.)
Jul 29, 2022	Z-0012-2023	—	open, classified	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.)
Jul 29, 2022	Z-0017-2023	—	open, classified	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.)
Jul 29, 2022	Z-0033-2023	—	open, classified	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.)
Jul 29, 2022	Z-0020-2023	—	open, classified	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.)
Jul 29, 2022	Z-0022-2023	—	open, classified	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.)
Jul 29, 2022	Z-0019-2023	—	open, classified	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.)
Jul 29, 2022	Z-0046-2023	—	open, classified	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.)
Jul 29, 2022	Z-0053-2023	—	open, classified	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.)
Jul 29, 2022	Z-0045-2023	—	open, classified	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.)
Jul 29, 2022	Z-0056-2023	—	open, classified	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.)
Jul 29, 2022	Z-0049-2023	—	open, classified	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.)
Jul 29, 2022	Z-0065-2023	—	open, classified	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.)
Jun 3, 2022	Z-1388-2022	—	open, classified	During use, the sheath of the device may accordion at the proximal end where the sheath meets the shrink band. Kinking of the sheath may prevent the snare from fully closing, and injury may result.
Dec 28, 2021	Z-0711-2022	—	open, classified	The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. The device is only cleared for gastrointestinal use and is not cleared for bronchial use.
May 1, 2018	Z-2052-2018	—	terminated	Device was marketed for uses outside the 510(k) clearance.
Mar 15, 2006	Z-0824-06	—	terminated	Diameter of device at the distal end would prevent it from passing through the endoscope's working channel.