Abbott recalls a specific lot of Ultimum Hemostasis Introducer devices due to being manufactured 12 cm instead of 5 cm in length. Affected units may cause complications during medical procedures.
As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length.
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Contact the company
📍Recalling firmAbbott5050 Nathan Ln N · Plymouth, MN 55442-3209
“Abbott Ultimum Hemostasis Introducer 5f 1.67 MM: Incorrect Length Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61532-abbott-ultimum-hemostasis-introducer-5f-1-67-mm-incorrect-length. Based on FDA recall #Z-0420-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0420-2022%22&limit=1).
The FDA announced on November 16, 2021, that Abbott recalled the Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM because a manufacturing error resulted in an incorrect hub and overall length. The devices were manufactured at 12 cm instead of the intended 5 cm.
How to tell if you have it
Brand: Abbott
Product: Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Model: 407831
Lot: 7748246
UPC: 15414734008805
The hazard
According to the FDA, one lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The affected devices measured 12 cm in length rather than the intended 5 cm.
Context
GovInfoNow's records show Abbott has 12 other recalls on record since April 5, 2018. Recent Abbott recalls include a September 10, 2025 TactiFlex Sensor Catheter recall for tip detachment risk and a March 17, 2025 Amplatzer TorqVue LP Catheter recall for small breach risk. Other recent recalls of similar products include a June 25, 2026 Micro Therapeutics Pipeline Flex Embolization Device recall for incorrect diameter label and a May 22, 2026 W L Gore GORE VIABIL Short Wire Biliary Endoprosthesis recall for incorrect labeling risk.
How to tell if you have this one
Check for the model number 407831 and lot number 7748246 on the device. The product was sold with GTIN 15414734008805.
Brand
Abbott
Product
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Verify the model number (407831) and lot number (7748246) on the device.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0420-2022 (November 16, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0420-2022 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.