CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code:… — Class II medical device recall Z-2663-2026
Ongoing recall by Bard Access Systems, Inc., reported 2026-07-08, distributed nationwide. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocain
| Recall number | Z-2663-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Access Systems, Inc., Salt Lake City, UT, United States |
| Recall initiated | 2026-05-21 |
| Classified | 2026-07-02 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE |
| Quantity | 2,844 |
| UPC / GTIN / UDI-DI | 00801741129278, 00801741129353, 00801741236150 |
| Lot numbers | P4254108, P4254108D, REJZ1337, REKW0949, REKX0112 |
Product
CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108 PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129278 P4254108D PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129353 The PowerMidline" Catheter is intended for short term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media.
Reason for recall
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2663-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.