Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv — Class II medical device recall Z-3095-2024
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-09-18, distributed nationwide. Potential for an incomplete seal on the packaging tray.
| Recall number | Z-3095-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-05-07 |
| Classified | 2024-09-10 |
| Reported by FDA | 2024-09-18 |
| Distributed | Nationwide (US) |
| Quantity | 46 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10193489081329, 20193489081326 |
| Lot numbers | 499617, 499843, 500207, 500315, 507265 |
| Model numbers | HARH36R |
Product
Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R.
Reason for recall
Potential for an incomplete seal on the packaging tray.
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-3095-2024. 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.