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Lower risk Medical device recall · FDA · Published November 2, 2021

Magnolia Medical Steripath Gen2 Blood Collection System Recall: Premature Needle

Magnolia Medical recalls Steripath Gen2 Blood Collection Systems (21G/23G) due to premature needle retraction complaints. Affected units have specific model numbers and lot numbers listed in the recall notice.

🇺🇸 FDA recall #Z-0318-2022Medical deviceMagnolia Medical ›
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Recalling firmMagnolia Medical Technologies, Inc.200 W Mercer St Ste 500 · Seattle, WA 98119-5908
✎ GovInfoNow plain-language explainer

Magnolia Medical is recalling its Steripath Gen2 Blood Collection Systems because users have reported premature needle retraction. This could lead to inaccurate blood tests or injury during blood draws if the needle retracts too soon. Read more at govinfonow.com/recall/61601-magnolia-medical-steripath-gen2-blood-collection-system-recall-premature-needle.

Source Summary by GovInfoNow · govinfonow.com/recall/61601-magnolia-medical-steripath-gen2-blood-collection-system-recall-premature-needle · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0318-2022

Cite this page

“Magnolia Medical Steripath Gen2 Blood Collection System Recall: Premature Needle.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61601-magnolia-medical-steripath-gen2-blood-collection-system-recall-premature-needle. Based on FDA recall #Z-0318-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0318-2022%22&limit=1).

The FDA announced on 2021-11-02 that Magnolia Medical Technologies, Inc. is voluntarily recalling The Steripath Gen2 Blood Collection System due to premature needle retraction hazards. GovInfoNow's records show the recall affects 137,200 devices distributed nationwide.

How to tell if you have it

  • Brand: Magnolia Medical
  • Product: Steripath Gen2 Blood Collection System
  • Model Numbers: 2700-21-EN, 2700-23-EN, 27BD-21-EN, 27BD-23-EN
  • Lot Numbers: 9447412, 9447043, 9446903, 9447120, 9446991, 9447413, 9446807, 9447124, 5005432, 9446708, 9447121, 5005328, 9446696, 9446547, 9446994, 9447122

The hazard

The recall is due to an uptick of complaints associated with premature needle retraction of the blood collection system. The record does not report specific incidents or injuries.

Context

GovInfoNow's records show Magnolia Medical Technologies, Inc. has 1 other recall on record since 2021-08-02. Other recent recalls of similar products include B Braun Medical Blood Set Recall (2025-10-29), Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (2026-07-13), and GVS TM SQ40S Blood Transfusion Filter Recall (2025-11-03).

How to tell if you have this one

Check for model numbers 2700-21-EN, 2700-23-EN, 27BD-21-EN, or 27BD-23-EN on the product. Affected units also have specific lot numbers listed in the recall notice.

  • Brand
    Magnolia Medical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for model numbers 2700-21-EN, 2700-23-EN, 27BD-21-EN, or 27BD-23-EN on the product.

  2. Contact Manufacturer

    Reach out to Magnolia Medical for further assistance if you have the affected model numbers.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 27 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: named in the noticeWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “U.S. Nationwide distribution in the states of MD, WV, DE, VA, DC, IN, MI, MA, SC, NY, IL, TX, AL, OK, GA, NE, FL, MO, CA, CO, NM, AR, WY, KS, PA, WA, MT, and AZ.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, New Mexico, New York, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Washington, West Virginia, Wyoming.

Recall timeline

FDA terminated this recall 18 months after the firm started it.

1. Firm started the recall: Nov 2, 202112. FDA classified it Class II: Dec 1, 202123. Published in FDA’s Enforcement Report: Dec 8, 202134. FDA terminated the recall: May 8, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-0318-2022 (November 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0318-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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