FDA Device recall Z-3095-2024
Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv
- FDA Device
- Class II
- ongoing
- Published 2024-09-18
On 2024-09-18 the FDA classified a Class II recall of Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv by Medline Industries Northfield, citing potential for an incomplete seal on the packaging tray.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3095-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-07 |
| Published | 2024-09-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
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
Potential for an incomplete seal on the packaging tray.
Identifiers
| code_info | Item Number: HARH36R. UDI/DI: 20193489081326 (case), 10193489081329 (each). Lot Numbers: 499617, 499843, 500207, 500315, 507265. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3095-2024%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.