Recall Z-0490-2026 ยท NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
Stryker Sustainability Solutions
HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY
| Date | Nov 12, 2025 (initiated Sep 24, 2025) |
| Status | Open, Classified |
| Reason | Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation. |
| Root cause | Process control |
| Action | On September 23, 2025, Stryker issued an "Urgent: Medical Device Recall" notification dated September 22, 2025, to affected consignees. Styker asked consignees to take the following actions: 1. Inform individuals within your organization who need to be aware of this action. 2. Check your internal inventory to locate the affected product (Attachment B). Segregate the affected products, quarantine and discontinue use. 3. Please complete and return the Business Reply Form to SSSPFA@Stryker.com or use the QR Code on Attachment A. Response is required. a. If you have indicated that product remains |
| Quantity | 22, 476 units |
| Distribution | US Nationwide distribution and OUS (foreign) to country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170456 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology Stryker Sustainability Solutions, Apr 5, 2017 |