FDA Device recall Z-2689-2024
Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
- FDA Device
- Class II
- ongoing
- Published 2024-08-28
On 2024-08-28 the FDA classified a Class II recall of Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A by Stryker Sustainability Solutions, citing 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, w….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2689-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-02 |
| Published | 2024-08-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Stryker Sustainability Solutions |
| Distribution | US |
Product
Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
Reason
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.
Identifiers
| code_info | UDI-DI: 07613327483918, Lots: 0000111423, 0000115940, 0000117907, 0000124226, 0000129992, 0000169328, 0000176893, 00001…UDI-DI: 07613327483918, Lots: 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, HY91020484, 11915419, 11925385, 11928534, 11931083, 11939652, 11947005, 11954851, 11963779, 11970640, 11977657, 11980331, 11984244, 11987875, 11991652, 11995462, 11995692, 12002389, 12010328, 12023953, 12026719, 12030554, 12039815, 12053079, 12056896, 12063693, 12080618, 12088836, 12093498, 12098299, 12102817, 12112224, 12148349, 12160590, 12170555, 12179425, 12185364, 12202282, 12204592, 12226747, 12238271, 12251638, 12253223, 12256926, 12260046, 12260098, 12271761, 12275519, 12277794, 12296434, 12327605, 12330999, 12351043, 12354510, 12355927, 12361109, 12363874 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Stryker Sustainability Solutions
- BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
FDA Device · Class II · 2026-10-14 · Stryker Sustainability Solutions - REF:2B5LT Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2026-09-23 · Stryker Sustainability Solutions - REF:B11LT Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2026-09-23 · Stryker Sustainability Solutions - REF:B5LT Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2026-09-23 · Stryker Sustainability Solutions - REF:B5ST Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2026-09-23 · Stryker Sustainability Solutions
All Stryker Sustainability Solutions recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2689-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.