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Use caution Medical device recall · FDA · Published July 18, 2017

Vyaire AirLife Reduced Heparin Blood Sampler Recall: Incorrect Needle Size Risk

Vyaire Medical recalls AirLife Reduced Heparin arterial blood samplers (lot #0001047501) due to incorrect needle and syringe size that could cause injury during blood draws.

🇺🇸 FDA recall #Z-3080-2017Medical deviceVyaire Medical ›
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Recalling firmVyaire Medical75 N Fairway Dr · Vernon Hills, IL 60061-1845
✎ GovInfoNow plain-language explainer

What happened, in plain English

Vyaire Medical is recalling specific AirLife Reduced Heparin arterial blood samplers (lot #0001047501) because they contain a larger needle, syringe, and heparin amount than intended. This could lead to injury during blood draws if used incorrectly. Read more at govinfonow.com/recall/73398-vyaire-airlife-reduced-heparin-blood-sampler-recall-incorrect-needle-size.

Source Summary by GovInfoNow · govinfonow.com/recall/73398-vyaire-airlife-reduced-heparin-blood-sampler-recall-incorrect-needle-size · Updated September 20, 2026 · FDA enforcement record: FDA #Z-3080-2017

Cite this page

“Vyaire AirLife Reduced Heparin Blood Sampler Recall: Incorrect Needle Size Risk.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73398-vyaire-airlife-reduced-heparin-blood-sampler-recall-incorrect-needle-size. Based on FDA recall #Z-3080-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3080-2017%22&limit=1).

Why it’s dangerous

The recalled kit includes a larger needle (23 gauge, 1 inch) and syringe (3mL) than intended, plus more heparin (113IU) than specified. Using this kit could cause pain, bleeding, or other injury during blood draws due to the incorrect size and amount.

Who’s affected

Healthcare professionals who use the AirLife Reduced Heparin arterial blood samplers (lot #0001047501) are most at risk. Patients receiving blood draws with this specific kit may also be affected.

How to tell if you have this one

Check the lot number on the kit, which is 0001047501. The product is an AirLife Reduced Heparin arterial blood sampler with a 1mL syringe, 25G 5/8" needle, and Luer slip protective sheath.

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

What to do — step by step

  1. Check Kit Lot Number

    Look for the lot number 0001047501 on the kit packaging.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 8 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: named in the noticeMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: named in the noticeNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “Worldwide Distribution- Nationwide distribution to states of: FL, OK, VA, MI, TH, NM, MA, MO, WA, AND country of: Australia.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Massachusetts, Michigan, Missouri, New Mexico, Oklahoma, Virginia, Washington.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

1. Firm started the recall: Jul 18, 201712. FDA classified it Class II: Aug 28, 201723. Published in FDA’s Enforcement Report: Sep 6, 201734. FDA terminated the recall: Apr 24, 2019420172019
  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-3080-2017 (July 18, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3080-2017 to see it in context.
  • Plain-language summary written by qwen3:4b on September 20, 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