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Lower risk Medical device recall · FDA · Published October 4, 2024

Hobbs Medical Posi-Stop 25 Gauge Needle Recall: Injection Flow Issues

Hobbs Medical recalls Posi-Stop 25 Gauge needles (Catalog 4723) due to debris blocking flow. Affected units include specific lot numbers. Contact for return or replacement.

🇺🇸 FDA recall #Z-0476-2025Medical deviceHobbs Medical ›
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Contact the company

Recalling firmHobbs Medical, Inc.8 Spring St · Stafford Springs, CT 06076-1505
✎ GovInfoNow plain-language explainer

Hobbs Medical is recalling Posi-Stop 25 Gauge injection needles because some contain debris that blocks fluid flow. This could lead to failed injections if the needle doesn't work properly. Read more at govinfonow.com/recall/53798-hobbs-medical-posi-stop-25-gauge-needle-recall-injection-flow.

Source Summary by GovInfoNow · govinfonow.com/recall/53798-hobbs-medical-posi-stop-25-gauge-needle-recall-injection-flow · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0476-2025

Cite this page

“Hobbs Medical Posi-Stop 25 Gauge Needle Recall: Injection Flow Issues.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53798-hobbs-medical-posi-stop-25-gauge-needle-recall-injection-flow. Based on FDA recall #Z-0476-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0476-2025%22&limit=1).

The FDA announced on Oct. 4, 2024, that Hobbs Medical, Inc. is recalling Posi-Stop Injection Needles because injection solutions may not flow as intended due to manufacturing debris blocking the needle tip. The agency issued recall number Z-0476-2025 for the voluntary Class II recall.

How to tell if you have it

  • Brand: Hobbs Medical
  • Product: Posi-Stop Injection Needle, 25 Gauge
  • Catalog Number: 4723
  • UDI-DI: M84947230
  • Lot Numbers: H07-23-107, H08-23-034

The hazard

According to the FDA, injection solutions would not flow as intended through the tip of the 25-gauge needles. Investigations found that some units contained debris from the manufacturing process within the inner sheath that blocked the inner diameter of the needle.

Context

GovInfoNow's records show Hobbs Medical, Inc. has had four other recalls since May 1, 2018, including a July 29, 2022, recall for an incorrect expiration date on a Scope Introducer and a June 3, 2022, recall regarding sheath kinking in a Polypectomy Snare. Other recent recalls of similar products include a Feb. 2, 2026, B. Braun needle recall for dull tip risk and an Nov. 26, 2025, Medline kit recall for stuck check valves.

How to tell if you have this one

Check for Catalog Number 4723 on the needle packaging. Affected units include Lot Numbers H07-23-107 and H08-23-034.

  • Brand
    Hobbs Medical
  • Category
    Medical device
FDA recall event · 9 products

All 9 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    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.
Recall numberProduct, codes & lotsQuantity
Z-0468-2025Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720; Catalog Number: 4720; UDI-DI: M84947200; Lot Numbers: H07-23-103, H07-23-104, H08-23-020, H09-23-111.70 units
Z-0469-2025Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702; Catalog Number: 4702; UDI-DI: M84947020; Lot Numbers: H08-23-263, H01-24-114.45 units
Z-0470-2025Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706; Catalog Number: 4706; UDI-DI: M84947060; Lot Number: SD09-23-089.6 units
Z-0471-2025Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716; Catalog Number: 4716; UDI-DI: M84947160; Lot Number: H01-24-076.5 units
Z-0472-2025Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721; Catalog Number: 4721; UDI-DI: M84947210; Lot Number: H11-23-057.15 units
Z-0473-2025Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704; Catalog Number: 4704; UDI-DI: M84947040; Lot Numbers: H10-23-106, H11-23-059.6 units
Z-0474-2025Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718; Catalog Number: 4718; UDI-DI: M84947180; Lot Numbers: H08-23-264, H09-23-112.12 units
Z-0475-2025Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722; Catalog Number: 4722; UDI-DI: M84947220; Lot Numbers: H08-23-265, H09-23-113, H10-23-223, H11-23-058.198 units
Z-0476-2025Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723; Catalog Number: 4723; UDI-DI: M84947230; Lot Numbers: H07-23-107, H08-23-034.10 units
Based on the official FDA remedy

What to do — step by step

  1. Check Needle Lot Number

    Look for Lot Numbers H07-23-107 or H08-23-034 on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 15 states.

Alaska: nationwideAKMaine: nationwideMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: nationwideILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: named in the noticeMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Connecticut, Georgia, Indiana, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Tennessee, Vermont, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 54 days after the firm started it.

1. Firm started the recall: Oct 4, 202412. FDA classified it Class II: Nov 15, 202423. Published in FDA’s Enforcement Report: Nov 27, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0476-2025 (October 4, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0476-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA