Reprocessed ultrasonic shears recalled because they may stick in the on position
Stryker Sustainability Solutions is recalling 22,476 reprocessed HARMONIC FOCUS shears because a manufacturing issue may leave them stuck in the on position, causing continuous activation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: continuous activation of a surgical energy device can injure tissue, and no injuries are reported.
Plain-English summary
HARMONIC FOCUS Shears with Adaptive Tissue Technology, 9 cm length, REF HAR9F, a reprocessed single-use device from Stryker Sustainability Solutions, are being recalled.
Due to a manufacturing issue, the reprocessed shears may become stuck in the "on position", resulting in continuous activation.
The recall covers 22,476 units carrying UDI 37613327348249, across lots including 16275164, 16284043, 16288055, 16294327 and 16296918. The product was distributed nationwide in the United States and to Canada. The FDA has classified the action as Class II.
An ultrasonic instrument that stays active when the surgeon releases it can deliver energy to tissue unintentionally. The enforcement record reports no injuries. Facilities should quarantine affected lots and follow Stryker's instructions.
The recalled product
- Product
- HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY
- Manufacturer
- Stryker Sustainability Solutions
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Stryker Sustainability Solutions
See all →- HighDaig Livewire Steerable Electrophysiology Catheter Sterile Seal Defect Recall
FDA (Devices) · 2026-05-20
- HighReprocessed electrophysiology catheters recalled over incomplete sterile seals
FDA (Devices) · 2026-05-20
- HighReprocessed Electrophysiology Catheter Recalled for Incomplete Seals
FDA (Devices) · 2026-05-20
- HighDaig Livewire Steerable Electrophysiology Catheters Recalled for Incomplete Seals
FDA (Devices) · 2026-05-20
- HighReprocessed Electrophysiology Catheter Recalled for Incomplete Sterile Seals
FDA (Devices) · 2026-05-20