DDU-100 Lifeline Automated External Defibrillator — Class II medical device recall Z-1312-2023
Ongoing recall by Defibtech, LLC, reported 2023-04-05, distributed nationwide. A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing,
| Recall number | Z-1312-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Defibtech, LLC, Guilford, CT, United States |
| Recall initiated | 2023-02-14 |
| Classified | 2023-03-30 |
| Reported by FDA | 2023-04-05 |
| Distributed | Nationwide (US) |
| Quantity | 29 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00815098020003 |
| Serial numbers | 101702198, 101702263, 101702424, 101702524, 101702535, 101702540, 101702544, 101702545, 101703267, 101703269, 101703272, 101703274, 101703276, 101703277, 101703278, 101703281, 101703312, 101703326, 101703378, 101703407, 101703411, 101703412, 101703419, 101703424, 101703427 and 4 more |
Product
DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
Reason for recall
A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy.
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-1312-2023. 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.