Covidien recalls Endo GIA Auto Suture Universal Articulating Loading Units with potential incomplete staple formation during surgery, risking bleeding. Affected units have specific lot numbers.
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
Covidien is recalling Endo GIA Auto Suture Universal Articulating Loading Units that may not form staples properly during surgery, which could lead to bleeding. This recall affects specific lot numbers of the product used in surgical procedures.
The device staples may not form correctly during application, which can prevent proper bleeding control. This could lead to incomplete staple formation and potential bleeding during surgical procedures.
Surgical professionals using the Endo GIA Auto Suture Universal Articulating Loading Units for procedures like abdominal or gynecologic surgery. The risk is low as the issue involves potential incomplete staple formation rather than immediate danger.
Check the lot numbers listed: T0A019X, T7K037X, T8H021X, T8L102X, T9E097X, T0A105X, T7K038X, T8H050X, T8L103X, T9E098X, T0A117X, T7K039X, T8J044X, T8M010X, T9F025X, T0A141X, T7K040X, T8J045X, T9A037X, T9F047X, T0B132X, T7K041X, T8J060X, T9A128X, T9F048X, T0C045X, T7L040X, T8K044X, T9B002X, T9F098X, T0C102X, T7L041X, T8K045X, T9B003X, T9H112X, T0C128X, T8B042X, T8K046X, T9C065X, T9H146X, T0D057X, T8B043X, T8K052X, T9C066X, T9K003X, T0D120X, T8C032X, T8K075X, T9C111X, T9L039X, T7G002X, T8C033X, T8K076X, T9C145X, T9M029X, T7H005X, T8E059X, T8K092X, T9D140X, T9M049X, T7H008X, T8E060X, T8L033X, T9E027X, T9M050X, T7K036X, T8H020X, T8L099X.
Review the lot numbers listed in the recall notice to determine if your unit is affected.
The device staples may not form properly during application, which can prevent adequate hemostasis and lead to incomplete staple formation.
The affected lot numbers are: T0A019X, T7K037X, T8H021X, T8L102X, T9E097X, T0A105X, T7K038X, T8H050X, T8L103X, T9E098X, T0A117X, T7K039X, T8J044X, T8M010X, T9F025X, T0A141X, T7K040X, T8J045X, T9A037X, T9F047X, T0B132X, T7K041X, T8J060X, T9A128X, T9F048X, T0C045X, T7L040X, T8K044X, T9B002X, T9F098X, T0C102X, T7L041X, T8K045X, T9B003X, T9H112X, T0C128X, T8B042X, T8K046X, T9C065X, T9H146X, T0D057X, T8B043X, T8K052X, T9C066X, T9K003X, T0D120X, T8C032X, T8K075X, T9C111X, T9L039X, T7G002X, T8C033X, T8K076X, T9C145X, T9M029X, T7H005X, T8E059X, T8K092X, T9D140X, T9M049X, T7H008X, T8E060X, T8L033X, T9E027X, T9M050X, T7K036X, T8H020X, T8L099X.
No immediate stop is required; the recall involves checking lot numbers to determine if the unit is affected.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0006-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0006-2021 from Covidien. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
