Becker External Drainage and Monitoring System: 24146 EDMS 24146… — Class I medical device recall Z-0661-2025
Ongoing recall by Medtronic Neurosurgery, reported 2024-12-25, distributed nationwide. Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainag
| Recall number | Z-0661-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neurosurgery, Fort Worth, TX, United States |
| Recall initiated | 2024-11-01 |
| Classified | 2024-12-19 |
| Reported by FDA | 2024-12-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BB, BH, CA, CH, CL, CN, CO, CR, CW, CY, CZ, DE, DK, DO, DZ, EG, ES, FI, GB, GH, GR, HK, HN, ID, IL, IS, IT, JM, JO, KE, KW, LB, LV, MA, MT, MY, NI, NL, NO, NZ, OM, PA, PE, PL, PT, QA, RO, SA, SE, SG, SK, TH, TN, TT, TW, UY, VN, ZA |
| Quantity | 65,810 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00763000333423, 00763000333430, 00763000333447, 00763000333485, 00763000333522, 00763000333539, 00763000333553, 00763000333577, 00763000333584, 00763000333591, 00763000333638, 00763000333669, 00763000333676, 00763000333683, 00763000406066, 00763000406073, 00763000431259, 00763000431297, 00763000467326, 00763000529307, 00763000529345 |
| Lot numbers | 219603333, 219603334, 219603335, 219642506, 219653249, 219653255, 219656939, 219656940, 219694908, 219712762, 219712763, 219712764, 219712765, 219712914, 219728986, 219738928, 219744775, 219744779, 219744900, 219798953, 219798954, 219807231, 219807627, 219839808, 219839809, 219887170, 219887171, 219887172, 219890583, 219912494, 219912495, 219926903, 219968507, 219988065, 219988526, 220018272, 220018274, 220018276, 220051377, 220051379 and 456 more |
Product
Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040 BECKER EDMS II 27609 BECKER 27609 W/NEEDLESLESS INJ. SITE 27670 BECKER 27670 STOP BELOW DC NDL-LS IN 27672 BECKER 27672 ONEWAY VLV Y-SITE PT LN 27702 EDMS 27702 EURO BECKER II GR PT LN 27761 BECKER 27761 STOP BCNDLESS PATLN 24 27767 BECKER 27767 NO STPCOCK ON PTLN 63 27779 EDMS 27779 BECKER BC NDLESS BOND CONN 27811 EDMS 27811 BECKER GRN PL VCATH 27931 EDMS 27931 BECKER GS TUBING SMARTSITES 46128 EDMS 46128 BECKER II BLUE PT LN 46129 EDMS 46129 EURO BECKER II BLUE PT LN The Becker External Drainage and Monitoring System (Becker EDMS) is a closed system for: 1. Draining cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space. 2. Monitoring CSF pressure and flow rate from the lateral ventricles of the brain and the lumbar subarachnoid space.
Reason for recall
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
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-0661-2025. 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.