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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
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