FDA Device recall Z-0120-2024
MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv
- FDA Device
- Class II
- ongoing
- Published 2023-10-25
On 2023-10-25 the FDA classified a Class II recall of MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv by Medline Industries Northfield, citing various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0120-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-03 |
| Published | 2023-10-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries Northfield |
| Distribution | n/a |
Product
MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.
Reason
Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
Identifiers
| code_info | UDI/DI 10193489081336 (each), 20193489081333 (case), Lot Numbers: 498739, 498740, 499057, 499143, 499227 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0120-2024%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.