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3 reported ongoing
3 records in this archive. Latest source date Sep 11, 2025.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
The devices were shipped unsterilized.
Class IIReported ongoing
Distribution: International distribution to the countries of United Arab Emirates.
Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be requir...
Class IReported ongoing
Distribution: US distribution nationwide. OUS distribution to EMEA, LATAM, APAC, and Canada.
There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, o...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada and Brazil.
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 3 records, including 3 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.