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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 4 of 6

Device	Model / Reference	Registries	Class	Status
Freeman Pancreatic Flexi-Stent Kit	6512	FDA UDI	Class II	Active
Flex-Ez Stylet Wire Balloon Dilator	3760	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4575OLY	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6517	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4563	FDA UDI	Class II	Active
Biliary Over the Wire Balloon Dilator	3180	FDA UDI	Class II	Active
Hobbs Biliary Amsterdam Stent Kit	6006	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6551	FDA UDI	Class II	Active
Hobbs Helical Retrieval Basket	4830	FDA UDI	Class II	Active
Hobbs Helical Retrieval Basket	4806	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6524	FDA UDI	Class II	Active
Flex-Ez Guidewire	3412	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6523	FDA UDI	Class II	Active
Hobbs Biliary Amsterdam Stent	6115	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4571	FDA UDI	Class II	Active
Hobbs Medical Mistifier Spray Catheter	2190	FDA UDI	Class II	Active
Hobbs Biliary Pigtail Stent Kit	6003	FDA UDI	Class II	Active
Flex-Ez Over the Wire Balloon Dilator	3210	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6555	FDA UDI	Class II	Active
Hobbs Helical Retrieval Basket	4832	FDA UDI	Class II	Active
Hobbs Pusher Catheter	6138	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6503	FDA UDI	Class II	Active
Hobbs Medical Scope Introducer	4650	FDA UDI	Class I	Active
Freeman Pancreatic Flexi-Stent Kit	6520	FDA UDI	Class II	Active
Hobbs Biliary Pigtail Stent Kit	6024	FDA UDI	Class II	Active
Hobbs Biliary Pigtail Stent	6107	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6575	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6341	FDA UDI	Class II	Active
Hobbs Medical Cytology Brush	4108	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6545	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6534	FDA UDI	Class II	Active
Hobbs Medical Cytology Brush	4206	FDA UDI	Class II	Active
Hobbs Aspiration Catheter	2181	FDA UDI	Class II	Active
Hobbs Medical Cytology Brush	4112	FDA UDI	Class II	Active
Hobbs Helical Retrieval Basket	4808	FDA UDI	Class II	Active
Hobbs Biliary Pigtail Stent Kit	6004	FDA UDI	Class II	Active
Flex-Ez Over the Wire Balloon Dilator	3212	FDA UDI	Class II	Active
Hobbs Biliary Amsterdam Stent Kit	6013	FDA UDI	Class II	Active
Hobbs Biliary Pigtail Stent Kit	6002	FDA UDI	Class II	Active
Hobbs Posi-Stop Injection Needle	4716	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6351	FDA UDI	Class II	Active
Hobbs Posi-Stop Injection Needle	4712S	FDA UDI	Class II	Active
Hobbs Biliary Pigtail Stent Kit	6001	FDA UDI	Class II	Active
Hobbs Posi-Stop Injection Needle	4708	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4577OLY	FDA UDI	Class II	Active
Flex-Ez Over the Wire Balloon Dilator	3254	FDA UDI	Class II	Active
Hobbs Biliary Amsterdam Stent Kit	6015	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4564OLY	FDA UDI	Class II	Active
Flex-Ez Stylet Wire Balloon Dilator	3742	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6528	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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Importers

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Authorities

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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.