HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Devic...
FDA Device Recall #Z-0490-2026 — Class II — September 24, 2025
Recall Summary
| Recall Number | Z-0490-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 24, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Sustainability Solutions |
| Location | Tempe, AZ |
| Product Type | Devices |
| Quantity | 22, 476 units |
Product Description
HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY
Reason for Recall
Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
Distribution Pattern
US Nationwide distribution and OUS (foreign) to country of: Canada.
Lot / Code Information
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 16573872 16575403 16576366 16576418 16579676 16583068 16585378 16587095 16587292 16592009 16592273 16595099 16595611 16598700 166xxxxx Lot Numbers: 16602578 16604258 16607822 16612246 16614330 16617406 16625703 16630079 16630328 16632353 16636528 16640175 16641167 16644299 16645144 16645768 16649786 16652064 16655193 16656536 16659901 16661415 16664176 16681913 16683266 16690151 16693679 167xxxxx Lot Numbers: 16705748 16759491 16762280 16763927 16766282 16767078 16768138 16768724 16769146 16775982 16778745 16779900 16795717 16796578 16797254 16797381 16797381 16799710 168xxxxx Lot Numbers: 16801351 16801564 16804498 16806005 16821036 16828177 16843649 16844103 16848493 16852781 16864607 16867268 16881353 16888650 16895321 16898535 169xxxxx Lot Numbers: 16910107 16913454 16920690 16928682 16931180 16935100 16945644 16951372 16962742 16967419 16969395 16977884 16979276 16981365 16988861 16991698 16993581 16996795 170xxxxx Lot Numbers: 17001825 17009610 17012825 17016204 17021294
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| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2689-2024 | Class II | Disposable 5 Lead Cable and Lead Wire System, 5... | Jul 2, 2024 |
| Z-2405-2024 | Class II | REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (... | May 31, 2024 |
| Z-2268-2024 | Class II | Stryker Sustainability Solutions, BW Lasso 2515... | May 10, 2024 |
| Z-2394-2023 | Class II | HoverMatt, 39" W x 78" L, REF: HM39SPU-B | Jun 21, 2023 |
| Z-1612-2023 | Class II | REF 5065, Kendall, Impad Rigid Sole Foot Cover,... | Apr 14, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.