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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 2 of 6

Device	Model / Reference	Registries	Class	Status
Hobbs Biliary Pigtail Stent Kit	6027	FDA UDI	Class II	Active
Hobbs Medical Grasping Forceps	5008	FDA UDI	Class II	Active
Hobbs Medical Saccomanno Cell Transport System	4101	FDA UDI	Class I	Active
Freeman Pancreatic Flexi-Stent Kit	6511	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6501	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4564	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6566	FDA UDI	Class II	Active
Hobbs Posi-Stop Injection Needle	4720	FDA UDI	Class II	Active
Hobbs Posi-Stop Injection Needle	4718	FDA UDI	Class II	Active
Flex-Ez Stylet Wire Balloon Dilator	3736	FDA UDI	Class II	Active
Biliary Over the Wire Balloon Dilator	3182	FDA UDI	Class II	Active
Hobbs Biliary Amsterdam Stent Kit	6011	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6562	FDA UDI	Class II	Active
Flex-Ez Stylet Wire Balloon Dilator	3744	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6342	FDA UDI	Class II	Active
Hobbs Biliary Pigtail Stent Kit	6028	FDA UDI	Class II	Active
Hobbs Biliary Amsterdam Stent Kit	6012	FDA UDI	Class II	Active
Flex-Ez Over the Wire Balloon Dilator	3204	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6516	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4572	FDA UDI	Class II	Active
Hobbs Medical Cytology Brush	4110	FDA UDI	Class II	Active
Flex-Ez Over the Wire Balloon Dilator	3250	FDA UDI	Class II	Active
Flex-Ez Stylet Wire Balloon Dilator	3714	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6522	FDA UDI	Class II	Active
Hobbs Achalasia Dilation Balloon	3302	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6518	FDA UDI	Class II	Active
Flex-Ez Stylet Wire Balloon Dilator	3764	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4573OLY	FDA UDI	Class II	Active
Flex-Ez Stylet Wire Balloon Dilator	3758	FDA UDI	Class II	Active
Flex-Ez Over the Wire Balloon Dilator	3260	FDA UDI	Class II	Active
Hobbs Biliary Amsterdam Stent	6118	FDA UDI	Class II	Active
Flex-Ez Over the Wire Balloon Dilator	3206	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4565OLY	FDA UDI	Class II	Active
Hobbs Achalasia Dilation Balloon	3306	FDA UDI	Class II	Active
Flex-Ez Over the Wire Balloon Dilator	3104	FDA UDI	Class II	Active
Hobbs Biliary Amsterdam Stent Kit	6014	FDA UDI	Class II	Active
Flex-Ez Over the Wire Balloon Dilator	3266	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6535	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	7202	FDA UDI	Class II	Unknown
Flex-Ez Over the Wire Balloon Dilator	3106	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4563OLY	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6541	FDA UDI	Class II	Active
Hobbs Helical Retrieval Basket	4814	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4570OLY	FDA UDI	Class II	Active
Hobbs Medical Transbronchial Aspiration Needle	4621	FDA UDI	Class I	Active
Freeman Pancreatic Flexi-Stent	6533	FDA UDI	Class II	Active
Flex-Ez Guidewire	3410	FDA UDI	Class II	Active
Hobbs Posi-Stop Injection Needle	4712S-01	FDA UDI	Class II	Active
Hobbs Helical Retrieval Basket	4824	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4561	FDA UDI	Class II	Active

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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.