Signia recallZ-0485-2026 · Covidien, LP · initiated Sep 25, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Covidien, LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
FDA root cause category: Process control
What the company is doing
On September 25, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Customer actions: Identify and quarantine all unused impacted product listed. Return all quarantined devices to Medtronic. If purchased from a distributor, contact your distributor directly to arrange for the return of the devices back to your distributor. Please complete and return the enclosed Customer Confirmation Form. Pass on this notice to all those who need to be aware within your organization or to any organization where the listed affected lots may have been transferred or distributed.
Recall details
- Recall number
- Z-0485-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 25, 2025
- Posted by the FDA
- Nov 7, 2025
- Recalling firm
- Covidien, LP
- Quantity
- 3263 units
- Product code
- GDW
- FDA submissions
- K191070, K222641
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Chile, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Kuwait, Malaysia, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, United Kingdom.
Product description
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
Code information (models, lots, serial numbers)
CFN: SIGSDL45CTVT; UDI-DIs: (1) 20884521741840, (2) 10884521741843; Lot numbers: N5F1971Y, N5F1723Y, N5D1858UY, N5B1134UY;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Signia SIGSDL45CTVTCovidien LP · Staple, implantable2 recalls27 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K191070, K222641 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Signia SIGSDS30CTVTCovidien LP · Staple, implantable2 recalls1 death152 reports
- Signia SIGSDS30CTVCovidien LP · Staple, implantable1 recall1 death80 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97792).
- Z-0486-2026 · Open, ClassifiedCovidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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