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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 3 of 6

Device	Model / Reference	Registries	Class	Status
Freeman Pancreatic Flexi-Stent Kit	6519	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6505	FDA UDI	Class II	Active
Hobbs Posi-Stop Injection Needle	4723	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6582	FDA UDI	Class II	Active
Hobbs Helical Retrieval Basket Handle	4850	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4570	FDA UDI	Class II	Active
Flex-Ez Over the Wire Balloon Dilator	3202	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4565	FDA UDI	Class II	Active
Good Bi-Brush	4660	FDA UDI	Class II	Active
Flex-Ez Over the Wire Balloon Dilator	3158	FDA UDI	Class II	Active
Hobbs Posi-Stop Injection Needle	4714	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6568	FDA UDI	Class II	Active
Hobbs Biliary Pigtail Stent	6109	FDA UDI	Class II	Active
Flex-Ez Stylet Wire Balloon Dilator	3712	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6546	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6515	FDA UDI	Class II	Active
Hobbs Biliary Pigtail Stent Kit	6023	FDA UDI	Class II	Active
Hobbs Nasal Cytology Brush	4291	FDA UDI	Class I	Active
Flex-Ez Over the Wire Balloon Dilator	3208	FDA UDI	Class II	Active
Hobbs Medical Cytology Brush	4106	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6574	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6548	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4577	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6571	FDA UDI	Class II	Active
Hobbs Inflation Monitor	4630	FDA UDI	Class II	Active
Flex-Ez Stylet Wire Balloon Dilator	3756	FDA UDI	Class II	Active
Flex-Ez Stylet Wire Balloon Dilator	3708	FDA UDI	Class II	Active
Hobbs Biliary Amsterdam Stent	6113	FDA UDI	Class II	Active
Biliary Over the Wire Balloon Dilator	3184	FDA UDI	Class II	Active
Flex-Ez Over the Wire Balloon Dilator	3262	FDA UDI	Class II	Active
Hobbs Biliary Pigtail Stent	6104	FDA UDI	Class II	Active
Hobbs Single Cleaning Brush	4677	FDA UDI	Class II	Active
Hobbs Posi-Stop Injection Needle	4706	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4572OLY	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4573	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6513	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6514	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6521	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6542	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6527	FDA UDI	Class II	Active
Hobbs Biliary Amsterdam Stent	6110	FDA UDI	Class II	Active
Hobbs Medical Grasping Forceps	5030	FDA UDI	Class II	Active
Good Bi-Brush	4665	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4562	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6506	FDA UDI	Class II	Active
Flex-Ez Stylet Wire Balloon Dilator	3732	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4561OLY	FDA UDI	Class II	Active
Hobbs Medical Grasping Forceps	5030S	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6576	FDA UDI	Class II	Active
Hobbs Medical Mistifier Spray Catheter	2191	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.