Lower riskMedical device recall · FDA · Published January 17, 2020
Covidien Endo GIA Ultra Stapler Recall: Infection Risk from Sterile Barrier Compromise
Covidien recalls 12mm Endo GIA Ultra Universal Staplers for potential infection risk if sterile barrier is compromised. Affected items have specific item codes and lot numbers.
Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection
Take action
Contact the company
📍Recalling firmCOVIDIEN LLC15 Hampshire St · Mansfield, MA 02048-1113
“Covidien Endo GIA Ultra Stapler Recall: Infection Risk from Sterile Barrier Compromise.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65980-covidien-endo-gia-ultra-stapler-recall-infection-risk-from-sterile. Based on FDA recall #Z-1264-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1264-2020%22&limit=1).
The FDA announced on Jan. 17, 2020, that Covidien LLC voluntarily recalled the Covidien Endo GIA Ultra Universal Stapler 12 mm due to a potential compromise of the sterile barrier. This defect may increase the risk of infection for patients. The recall affects 2,180 units distributed in the U.S., Israel, and Japan.
How to tell if you have it
Brand: Covidien
Product: Covidien Endo GIA Ultra Universal Stapler 12 mm
Item Code: EGIAUSTND
Lot Number: P9E0022Y
The hazard
The recall addresses the potential for the sterile barrier to be compromised. According to the FDA, products with a compromised sterile barrier may result in a potentially increased risk for infection.
Context
GovInfoNow's records show Covidien LLC has 52 other recalls on record since Aug. 7, 2017. Other recent recalls of similar products include the Covidien EndoFLIP System recall (May 13, 2026), the Covidien Mon-a-Therm Stethoscope Recall (April 23, 2026), and the Covidien Shiley Disposable Decannulation Plug Recall (April 23, 2026). Additional similar recalls include the Covidien EndoStitch Polysorb Loading Unit Recall (April 15, 2026), the Covidien Surgipro II S8698GX recall (June 24, 2026), and the Covidien V-Loc 90 Wound Closure Device Recall (June 24, 2026).
How to tell if you have this one
Check for the item code EGIAUSTND and lot number P9E0:0022Y on the product. These devices are intended for resection and transection in general surgery procedures.
Brand
Covidien
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for item code EGIAUSTND and lot number P9E0022Y on the device.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US Nationwide, Israel, and Japan” 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 2.5 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.
Is this a safety hazard that requires immediate action?
No immediate action is needed. The recall is for potential infection risk if the sterile barrier is compromised, which requires checking product details.
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-1264-2020 (January 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1264-2020 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.