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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 1 of 6

Device	Model / Reference	Registries	Class	Status
Hobbs Medical Polypectomy Snare	4567OLY	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6565	FDA UDI	Class II	Active
Hobbs Microbiology Brush	4320	FDA UDI	Class II	Active
Hobbs Medical Cytology Brush	4202	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6564	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4562OLY	FDA UDI	Class II	Active
Hobbs Medical Grasping Forceps	5004	FDA UDI	Class II	Active
Hobbs Posi-Stop Injection Needle	4714S	FDA UDI	Class II	Active
Hobbs Biliary Pigtail Stent	6106	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6585	FDA UDI	Class II	Active
Flex-Ez Stylet Wire Balloon Dilator	3738	FDA UDI	Class II	Active
Hobbs Posi-Stop Injection Needle	4718S	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4575	FDA UDI	Class II	Active
Hobbs Posi-Stop Injection Needle	4721	FDA UDI	Class II	Active
Hobbs Posi-Stop Injection Needle	4720S	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4560	FDA UDI	Class II	Active
Hobbs Pusher Catheter	6136	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4571OLY	FDA UDI	Class II	Active
Hobbs Biliary Amsterdam Stent Kit	6009	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6507	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6584	FDA UDI	Class II	Active
Hobbs Posi-Stop Injection Needle	4712	FDA UDI	Class II	Active
Hobbs Aspiration Catheter	2182	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6310	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6567	FDA UDI	Class II	Active
Hobbs Pusher Catheter	6132	FDA UDI	Class II	Active
Hobbs Microbiology Brush	4352	FDA UDI	Class II	Active
Flex-Ez Stylet Wire Balloon Dilator	3734	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6531	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6525	FDA UDI	Class II	Active
Hobbs Biliary Amsterdam Stent	6117	FDA UDI	Class II	Active
Hobbs Posi-Stop Injection Needle	4714S-01	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent Kit	6504	FDA UDI	Class II	Active
Flex-Ez Stylet Wire Balloon Dilator	3740	FDA UDI	Class II	Active
Hobbs Nasal Cytology Brush	4290	FDA UDI	Class I	Active
Hobbs Biliary Pigtail Stent	6108	FDA UDI	Class II	Active
Hobbs Biliary Amsterdam Stent	6111	FDA UDI	Class II	Active
Hobbs Medical Cytology Brush	4104	FDA UDI	Class II	Active
Hobbs Medical Cytology Brush	4102	FDA UDI	Class II	Active
Hobbs Single Cleaning Brush	4676	FDA UDI	Class II	Active
Hobbs Medical Polypectomy Snare	4567	FDA UDI	Class II	Active
Hobbs Guiding Catheter	6130	FDA UDI	Class II	Active
Freeman Pancreatic Flexi-Stent	6581	FDA UDI	Class II	Active
Hobbs Posi-Stop Injection Needle	4722	FDA UDI	Class II	Active
Hobbs Medical Grasping Forceps	5018	FDA UDI	Class II	Active
Flex-Ez Over the Wire Balloon Dilator	3152	FDA UDI	Class II	Active
Flex-Ez Over the Wire Balloon Dilator	3102	FDA UDI	Class II	Active
Flex-Ez Guidewire	3406	FDA UDI	Class II	Active
Hobbs Biliary Amsterdam Stent Kit	6005	FDA UDI	Class II	Active
Hobbs Posi-Stop Injection Needle	4704	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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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.