FDA Device recall Z-0490-2026
HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY
- FDA Device
- Class II
- ongoing
- Published 2025-11-19
On 2025-11-19 the FDA classified a Class II recall of HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY by Stryker Sustainability Solutions, citing due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0490-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-24 |
| Published | 2025-11-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Stryker Sustainability Solutions |
| Distribution | US |
Product
HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY
Reason
Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
Identifiers
| code_info | UDI: (01)37613327348249/ 162xxxxx Lot Numbers: 16275164 16284043 16288055 16294327 16296918 163xxxxx Lot Numbers: 16301…UDI: (01)37613327348249/ 162xxxxx Lot Numbers: 16275164 16284043 16288055 16294327 16296918 163xxxxx Lot Numbers: 16301496 16305751 16306347 16306436 16316531 16316651 16342389 16343642 16346325 16346612 16347602 16348678 16349187 16353884 16355545 16357189 16360679 16363788 16366396 16367903 16368245 16375951 16376461 16378500 16380079 16382574 16383957 16386402 16399914 164xxxxx Lot Numbers: 16405308 16407386 16408732 16410690 16413617 16413975 16416261 16418939 16420520 16422830 16432199 16432342 16436871 16436987 16442725 16444477 16446841 16448857 16449208 16449296 16453140 16459248 16463302 16464895 16467199 16471023 16475746 16482558 16487182 16488252 16491206 16492941 16494926 16497950 16498718 165xxxxx Lot Numbers: 16502233 16503856 16506269 16507481 16511866 16511995 16514496 16514579 16520053 16521262 16521892 16522603 16527022 16527858 16530602 16531805 16534581 16535595 16538257 16539232 16540322 16540636 16549592 16551658 16554621 16559625 16567068 16567902 16569680 16573 |
|---|
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-0490-2026%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.