HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO
FDA device recall Z-0490-2026 · posted 2025-11-12 · Open, Classified
Recall details
- Recalling firm
- Stryker Sustainability Solutions
- Reason for recall
- Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
- Action taken
- 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 in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to your facility for products returned upon receipt. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. For any additional information or questions please reach out to SSSPFA@stryker.com or Stryker Customer Service at 800-624-4422.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- NLQ
- Quantity affected
- 22, 476 units
- Distribution
- US Nationwide distribution and OUS (foreign) to country of: Canada.
- Date initiated
- 2025-09-24
- Date posted
- 2025-11-12
- Location
- Tempe, AZ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology (K170456) | Stryker Sustainability Solutions | 2017-04-05 |