FDA Device recall Z-0995-2026
R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100
- FDA Device
- Class II
- ongoing
- Published 2025-12-31
On 2025-12-31 the FDA classified a Class II recall of R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100 by Cook, citing 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 le….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0995-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-26 |
| Published | 2025-12-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cook |
| Distribution | n/a |
Product
R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
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.
Identifiers
| code_info | Reference Part Number RUPS-100: Order Number G06929, UDI (01)00827002069299(17)280624(10)16659065, Lot Number 16659065 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0995-2026%22
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