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Lower risk Medical device recall · FDA · Published February 3, 2022

Terumo Cardiovascular Kit Shipping Damage Risk - Recalled Products

Terumo recalls two cardiovascular procedure kits (catalog #76645 & 73806) due to potential shipping damage. Affected kits may have packaging issues that could impact use.

🇺🇸 FDA recall #Z-0949-2022Medical deviceTerumo ›
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Recalling firmTerumo Cardiovascular Systems Corp28 Howe St · Ashland, MA 01721-1305
✎ GovInfoNow plain-language explainer

Terumo is recalling two specific cardiovascular procedure kits (catalog numbers 76645 and 73806) because they might get damaged during shipping. This packaging issue could affect how the kits are used in medical procedures. Read more at govinfonow.com/recall/61185-terumo-cardiovascular-kit-shipping-damage-risk-recalled-products.

Source Summary by GovInfoNow · govinfonow.com/recall/61185-terumo-cardiovascular-kit-shipping-damage-risk-recalled-products · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0949-2022

Cite this page

“Terumo Cardiovascular Kit Shipping Damage Risk - Recalled Products.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61185-terumo-cardiovascular-kit-shipping-damage-risk-recalled-products. Based on FDA recall #Z-0949-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0949-2022%22&limit=1).

The FDA announced on Feb. 3, 2022, that Terumo Cardiovascular Systems Corp voluntarily recalled Cardiovascular Procedure Kits due to potential packaging damage from shipping. The agency issued recall number Z-0949-2022 for the affected devices.

How to tell if you have it

  • Brand: Terumo
  • Product: Cardiovascular Procedure Kit catalog # 76645 & 73806
  • Lot #Z15957677, case label GTIN: (01)00699753507685, product identifier: (17)230228(10)Z15957677
  • Lot #Z16958398, case label GTIN: (01)00699753477728, product identifier: (17)230228(10)Z16958398
  • UPC 00699753477728
  • UPC 00699753507685
  • Sold nationwide in the states of CA and IN

The hazard

The recall addresses potential damage to Cardiovascular Procedure Kit packaging that occurred during shipping, according to the FDA.

Context

GovInfoNow's records show Terumo Cardiovascular Systems Corp has one other recall on record since Dec. 18, 2017, involving possible blood leaks in LeukoGuard Filters. Other recent recalls of similar products include Medline Medical Procedure Kits: Catheter Issues Recalled (May 4, 2026), Windstone AMS Medical Kits: Lidocaine Injection Recall Due to Supplier Quality Issues (June 17, 2026), and Medline Convenience Kits Recall: Risk of Sterile Packaging Breach (June 12, 2026).

How to tell if you have this one

Check for catalog numbers 76645 or 73806 on the kit. Look for lot numbers Z15957677 or Z16958398 on the packaging.

  • Brand
    Terumo
  • Product
    Cardiovascular Procedure Kit catalog # 76645 & 73806
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Kit Details

    Look for catalog numbers 76645 or 73806 and lot numbers Z15957677 or Z16958398 on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 2 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of CA and IN.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Indiana.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

1. Firm started the recall: Feb 3, 202212. FDA classified it Class II: Apr 18, 202223. Published in FDA’s Enforcement Report: Apr 27, 202234. FDA terminated the recall: Feb 20, 2024420222024
  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-0949-2022 (February 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0949-2022 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