FDA Medical Device Recalls (openFDA)
Cook Incorporated: Rsch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The Rsch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
- Recall number
- Z-0995-2026
- Recalling firm
- Cook Incorporated
- Product
- Rsch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The Rsch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
- Status
- Open, Classified
- Initiated
- 2025-11-26
- Posted
- 2025-12-23
- Terminated
- not on file
- Reason
- Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
- Root cause
- Process control
- Action
- Cook Medical issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 11/26/2025 by email and/or letter delivered via a courier. The notice explained the issue, risk to health, and requested the identification and return of the affected product. The notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred. For questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
- Quantity
- 23 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- Reference Part Number RUPS-100: Order Number G06929, UDI (01)00827002069299(17)280624(10)16659065, Lot Number 16659065
- 510(k) numbers
- ["K171820"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- 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