Covidien recalls specific Signia Small Diameter Curved Tip Intelligent Reload staplers due to potential safety interlock failure, which may cause tissue trauma or bleeding during surgery.
Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, the stapler may cut tissue but no staples will deploy from the empty reload, potentially resulting in a failed anastomosis, bleeding, tissue trauma, and the potential need to convert to an open procedure.
Take action
Contact the company
📍Recalling firmCovidien, LP60 Middletown Ave · North Haven, CT 06473-3908
✎ GovInfoNow plain-language explainer
Covidien is recalling certain Signia Small Diameter Curved Tip Intelligent Reload staplers because their safety interlock might fail, leading to a failed anastomosis, bleeding, or tissue damage during surgery. This could require a switch to an open surgical procedure. Read more at govinfonow.com/recall/63164-covidien-signia-stapler-recall-safety-interlock-failure-risk.
“Covidien Signia Stapler Recall: Safety Interlock Failure Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63164-covidien-signia-stapler-recall-safety-interlock-failure-risk. Based on FDA recall #Z-1383-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1383-2021%22&limit=1).
The FDA announced on March 4, 2021, that Covidien, LP is recalling its Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long devices due to a potential safety interlock failure. This defect could cause the stapler to fire an empty reload without deploying staples, potentially leading to bleeding or tissue trauma.
How to tell if you have it
Brand: Covidien
Product Name: Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long
Units Affected: 5,928 worldwide (4,212 in the U.S., 1,716 outside the U.S.)
The hazard
The device's safety interlock may fail to prevent an empty single-use reload from being fired a second time. If this occurs, the stapler may cut tissue but will not deploy staples, potentially resulting in failed anastomosis, bleeding, tissue trauma, and the need to convert to an open procedure.
Context
GovInfoNow's records show Covidien, LP has issued 26 other recalls since July 17, 2017. Recent similar product recalls include the Wilson-Cook Instinct Plus Endoscopic Clipping Device (March 3, 2026), Intuitive 8 mm SureForm 30 Gray Reloads (March 11, 2026), and Medline 5.5" Sterile Scissors (November 13, 2025).
How to tell if you have this one
Check for the item code SIGSDL45CTVT on the device. The lot numbers listed include N0A1038UY through N9L0797UY. The unique device identifier (UDI) is 10884521741843 or 20884521741840.
Brand
Covidien
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Austria, Belgium, Chile, China, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom.
Recall number
Product, codes & lots
Quantity
Z-1383-2021
Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT; Lot Numbers: N0A1038UY N0E0016UY N0F0616UY N0K0934UY N0B0493UY N0F0254UY N0F0817UY N0M0334UY N0C0436UY N0F0518UY N0G0388UY N9K1095UY N0D0731UY N0F0615UY N0J0859UY N9L0797UY UDI: 10884521741843 20884521741840
5928 units WW: 4212 US 1716 OUS
Z-1384-2021
Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV; Lot Numbers: N0A0191UY N0D0392UY N0F0406UY N0L0708UY N0B0657UY N0E0133UY N0G0907UY N9K0376UY N0C0349UY N0E0956UY N0J0746UY N9K1093UY N0C0492UY N0E1026UY N0K0248UY N9L0796UY N0C1008UY N0F0202UY N0K0803UY N9M0418UY N0D0283UY N0F0221UY N0L0307UY N9M0651UY UDI: 10884521741881 20884521741888
11391 units WW: 5982 US 5409 OUS
Z-1385-2021
Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT; Lot Numbers: N0A0274UY N0D0037UY N0G0491UY N0K1016UY N0A0897UY N0D0391UY N0G0736UY N0L0077UY N0B0640UY N0E0175UY N0J0510UY N0M0063UY N0B0937UY N0E0802UY N0J0680UY N0M0259UY N0C0144UY N0F1055UY N0J0999UY N9K1094UY N0C0486UY N0G0185UY N0K0584UY N9L0795UY N0C1115UY N0G0250UY N0K0805UY UDI: 10884521741874 20884521741871
15298 units WW: 9204 US; 6094 OUS
Based on the official FDA remedy
What to do — step by step
Check Device Details
Identify the item code (SIGSDL45CTVT) and lot numbers (N0A1038UY to N9L0797UY) to confirm if your device is recalled.
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 and the countries of Austria, Belgium, Chile, China, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland,…” 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 3.4 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-1383-2021 (March 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1383-2021 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.