Data Foundry

Medical device recalls 2019

Replacement ECG leadwires with snap ends REF/Catalog Number… — Class III medical device recall Z-1879-2019

Terminated recall by GE Healthcare, LLC, reported 2019-07-03, distributed nationwide. ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, pot

Recall numberZ-1879-2019
Product typeMedical device
ClassificationClass III
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmGE Healthcare, LLC, Waukesha, WI, United States
Recall initiated2019-05-10
Classified2019-06-25
Reported by FDA2019-07-03
Terminated2024-05-24
DistributedNationwide (US)
Countries outside the USAE, AT, AU, BD, BE, BG, BM, BO, BR, CA, CH, CL, CO, CR, CY, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, HK, HN, HU, ID, IE, IL, IN, IQ, IS, IT, JM, JO, JP, KE, KR, KW, LB, LK, LT, LV, MA, MT, MX, NG, NL, NO, NP, NZ, OM, PA, PL, QA, RO, RS, RU, SE, SG, SI, SK, SV, TH, TR, TT, TW, UA, UY, VN, ZA

Product

Replacement ECG leadwires with snap ends REF/Catalog Number Description 2106386-101 Replacement ECG Leadwire, snap, LL, AHA, 130 cm/ 51 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.

Reason for recall

ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.

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-1879-2019. 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.