thejoe Hobbs Medical, Inc.

Hobbs Medical, Inc.: 73 FDA recall reports

Every medical device recall the FDA has published for Hobbs Medical, Inc.. The fault, and how the agency graded it.

73Reports

0Class I

72Ongoing

2024-11-27Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	73

By year reported

Year	Reports
2018	1
2022	63
2024	9

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723

Z-0476-2025 · Class II · reported 2024-11-27 · Ongoing

Why it was recalled: 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.
Product: Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723
Where it went: Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.
How much: 10 units

Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722

Z-0475-2025 · Class II · reported 2024-11-27 · Ongoing

Why it was recalled: 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.
Product: Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722
Where it went: Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.
How much: 198 units

Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721

Z-0472-2025 · Class II · reported 2024-11-27 · Ongoing

Why it was recalled: 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.
Product: Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721
Where it went: Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.
How much: 15 units

Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718

Z-0474-2025 · Class II · reported 2024-11-27 · Ongoing

Why it was recalled: 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.
Product: Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718
Where it went: Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.
How much: 12 units

Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716

Z-0471-2025 · Class II · reported 2024-11-27 · Ongoing

Why it was recalled: 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.
Product: Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716
Where it went: Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.
How much: 5 units

Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704

Z-0473-2025 · Class II · reported 2024-11-27 · Ongoing

Why it was recalled: 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.
Product: Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704
Where it went: Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.
How much: 6 units

Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702

Z-0469-2025 · Class II · reported 2024-11-27 · Ongoing

Why it was recalled: 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.
Product: Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702
Where it went: Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.
How much: 45 units

Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720

Z-0468-2025 · Class II · reported 2024-11-27 · Ongoing

Why it was recalled: 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.
Product: Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720
Where it went: Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.
How much: 70 units

Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706

Z-0470-2025 · Class II · reported 2024-11-27 · Ongoing

Why it was recalled: 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.
Product: Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706
Where it went: Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.
How much: 6 units

Hobbs Medical Polypectomy Snare Catalog Number: 4575-OLY

Z-0070-2023 · Class II · reported 2022-10-19 · Ongoing

Why it was recalled: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Product: Hobbs Medical Polypectomy Snare Catalog Number: 4575-OLY
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
How much: 10 units

Freeman Pancreatic Flexi-Stent Kit (containing 6533) Catalog Number: 6507

Z-0051-2023 · Class II · reported 2022-10-19 · Ongoing

Why it was recalled: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Product: Freeman Pancreatic Flexi-Stent Kit (containing 6533) Catalog Number: 6507
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
How much: 4 units

Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501

Z-0049-2023 · Class II · reported 2022-10-19 · Ongoing

Why it was recalled: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Product: Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
How much: 10 units

Hobbs Transbronchial Aspiration Needle Catalog Number: 4621

Z-0018-2023 · Class II · reported 2022-10-19 · Ongoing

Why it was recalled: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Product: Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
How much: 7 units

Hobbs Posi-Stop Injection Needle Catalog Number: 4722

Z-0025-2023 · Class II · reported 2022-10-19 · Ongoing

Why it was recalled: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Product: Hobbs Posi-Stop Injection Needle Catalog Number: 4722
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
How much: 17 units

Hobbs Medical Grasping Forceps Catalog Number:5004

Z-0034-2023 · Class II · reported 2022-10-19 · Ongoing

Why it was recalled: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Product: Hobbs Medical Grasping Forceps Catalog Number:5004
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
How much: 3 units

Hobbs Medical Polypectomy Snare Catalog Number: 4565-OLY

Z-0069-2023 · Class II · reported 2022-10-19 · Ongoing

Why it was recalled: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Product: Hobbs Medical Polypectomy Snare Catalog Number: 4565-OLY
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
How much: 10 units

Freeman Pancreatic Flexi-Stent Kit (containing 6568) Catalog Number: 6529

Z-0054-2023 · Class II · reported 2022-10-19 · Ongoing

Why it was recalled: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Product: Freeman Pancreatic Flexi-Stent Kit (containing 6568) Catalog Number: 6529
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
How much: 4 units

Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027

Z-0041-2023 · Class II · reported 2022-10-19 · Ongoing

Why it was recalled: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Product: Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
How much: N/A

Hobbs Medical Cytology Brush Catalog Number: 4204

Z-0013-2023 · Class II · reported 2022-10-19 · Ongoing

Why it was recalled: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Product: Hobbs Medical Cytology Brush Catalog Number: 4204
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
How much: 300 units

Freeman Pancreatic Flexi-Stent Catalog Number: 6533

Z-0055-2023 · Class II · reported 2022-10-19 · Ongoing

Why it was recalled: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Product: Freeman Pancreatic Flexi-Stent Catalog Number: 6533
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
How much: 6 units

Hobbs Helical Retrieval Basket Catalog Number: 4822

Z-0030-2023 · Class II · reported 2022-10-19 · Ongoing

Why it was recalled: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Product: Hobbs Helical Retrieval Basket Catalog Number: 4822
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
How much: 14 units

Hobbs Medical Cytology Brush Catalog Number: 4206

Z-0014-2023 · Class II · reported 2022-10-19 · Ongoing

Why it was recalled: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Product: Hobbs Medical Cytology Brush Catalog Number: 4206
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
How much: 300 units

Hobbs Helical Retrieval Basket Catalog Number: 4832

Z-0033-2023 · Class II · reported 2022-10-19 · Ongoing

Why it was recalled: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Product: Hobbs Helical Retrieval Basket Catalog Number: 4832
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
How much: 13 units

Freeman Pancreatic Flexi-Stent Kit (containing 6352) Catalog Number: 6321

Z-0046-2023 · Class II · reported 2022-10-19 · Ongoing

Why it was recalled: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Product: Freeman Pancreatic Flexi-Stent Kit (containing 6352) Catalog Number: 6321
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
How much: 6 units

Freeman Pancreatic Flexi-Stent Catalog Number: 6584

Z-0065-2023 · Class II · reported 2022-10-19 · Ongoing

Why it was recalled: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Product: Freeman Pancreatic Flexi-Stent Catalog Number: 6584
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
How much: 4 units

Hobbs Helical Retrieval Basket Catalog Number: 4806

Z-0026-2023 · Class II · reported 2022-10-19 · Ongoing

Why it was recalled: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Product: Hobbs Helical Retrieval Basket Catalog Number: 4806
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
How much: 4 units

Hobbs Posi-Stop Injection Needle Catalog Number: 4718

Z-0023-2023 · Class II · reported 2022-10-19 · Ongoing

Why it was recalled: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Product: Hobbs Posi-Stop Injection Needle Catalog Number: 4718
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
How much: 30 units

Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191

Z-0011-2023 · Class II · reported 2022-10-19 · Ongoing

Why it was recalled: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Product: Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
How much: 30 units

Hobbs Posi-Stop Injection Needle Catalog Number: 4702

Z-0020-2023 · Class II · reported 2022-10-19 · Ongoing

Why it was recalled: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Product: Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
How much: 8 units

Freeman Pancreatic Flexi-Stent Catalog Number: 6548

Z-0059-2023 · Class II · reported 2022-10-19 · Ongoing

Why it was recalled: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Product: Freeman Pancreatic Flexi-Stent Catalog Number: 6548
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
How much: 10 units

Showing the 30 most recent of 73. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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