Disposable 5 Lead Cable and Lead Wire System — Class II medical device recall Z-2689-2024
Ongoing recall by Stryker Sustainability Solutions, reported 2024-08-28, distributed nationwide. Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems
| Recall number | Z-2689-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Sustainability Solutions, Tempe, AZ, United States |
| Recall initiated | 2024-07-02 |
| Classified | 2024-08-20 |
| Reported by FDA | 2024-08-28 |
| Distributed | Nationwide (US) |
| Quantity | 38,850 |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 07613327483918 |
| Lot numbers | 0000111423, 0000115940, 0000117907, 0000124226, 0000129992, 0000169328, 0000176893, 0000178122, 0000181676, 0000206244, 0000210519, 0000211431, 0000213251, 0000217965, 0000219223, 0000221089, 0000228136, 0000231266, 0000236744, 0000238102, 0000240411, 0000240412, 0000250305, 0000291346, 0000356647, 0000372559, 0000445734, 0000474297, 0000541414, 0000549776, 11875844, 11893791, 11899068, 11902434, 11915419, 11925385, 11928534, 11931083, 11939652, 11947005 and 130 more |
| Model numbers | LW-309DS50/5A |
Product
Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
Reason for recall
Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems and a dual connect cable, may in fact contain, different ECG Leads, which are not approved for reprocessing, but that may have been reprocessed, which may lead to devices not performing as intended.
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-2689-2024. 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.