Z-2281-2026Class II

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

Name: Z-2281-2026 Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071
Creator: Covidien, LP
Published: 2026-04-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2026-04-15 / Open, Classified / root cause: manufacturing process

FDA source

Covidien, LP began a recall of Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071 on 2026-04-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2281-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-15
Posted: 2026-06-01
Recalling firm: Medtronic, Inc.
Product: Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
Product code: OCW Endoscopic Tissue Approximation Device
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 2448 units
Distribution: Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;
Product codes and lots: 1. Product Number: 170053; UDI-DI: 10884521126732; UPN: 20884521126739; Lot number: J5L2332Y; 2. Product Number: 170071; UDI-DI: 10884521126787; UPN: 20884521126784; Lot number: J5H2924Y;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2281-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2281-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-06-01

Product code OCW

K934738Class IIAutosuture Endoscopic Suturing DeviceUnited States Surgical, A Division of Tyco Healthc / cleared 1994-03-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)