Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;

FDA device recall Z-2281-2026 · posted 2026-06-01 · Open, Classified

Recall details

Recalling firm

Covidien, LP

Reason for recall

The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.

Action taken

On April 23, 2026 URGENT: VOLUNTARY MEDICAL DEVICE RECALL letters were sent to customers. Customer actions: - Immediately identify and quarantine all unused impacted product listed above. - See Appendix A for guidance on identifying affected lots. - This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Return all unused impacted product listed above to Medtronic. Medtronic Actions: - Medtronic representatives will assist customers with the return of affected product, upon request. - Medtronic representatives will work with customers to ensure replacement products are available to avoid interruptions in patient care.

Root cause

Process control

Status

Open, Classified

Product code

OCW

Quantity affected

2448 units

Distribution

Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;

Date initiated

2026-04-15

Date posted

2026-06-01

Location

North Haven, CT

Related 510(k) clearances