FDA Medical Device Recalls (openFDA)
Covidien, LP: Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
- Recall number
- Z-2281-2026
- Recalling firm
- Covidien, LP
- Product
- Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
- Status
- Open, Classified
- Initiated
- 2026-04-15
- Posted
- 2026-06-01
- Terminated
- not on file
- Reason
- 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
- 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
- 2448 units
- Distribution
- Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;
- Lot, serial or model codes
- 1. Product Number: 170053; UDI-DI: 10884521126732; UPN: 20884521126739; Lot number: J5L2332Y; 2. Product Number: 170071; UDI-DI: 10884521126787; UPN: 20884521126784; Lot number: J5H2924Y;
- 510(k) numbers
- ["K934738"]
- PMA numbers
- not on file
- Product code
- OCW
- Firm FEI
- 1219930
- Firm city
- North Haven
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28