Stryker recalls reprocessed Harmonic Focus Shears with Adaptive Tissue Technology that may become stuck in the 'on' position, causing continuous activation. Affected units have specific lot numbers and were sold for single-use procedures.
Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
Stryker is recalling reprocessed Harmonic Focus Shears that may get stuck in the 'on' position, causing them to stay activated. This could lead to unintended cuts during medical procedures if the shears are used without proper control.
The shears may become stuck in the 'on' position due to a manufacturing issue, causing continuous activation. This means the shears could cut tissue without the user's intended control during surgery.
Healthcare professionals using these shears for surgical procedures are most at risk. Patients undergoing surgery with the recalled shears could face unintended cuts if the device remains activated.
Check for the model 'HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length' with reference number HAR9F. Affected units have specific lot numbers listed in the recall notice, including ranges like 162xxxxx and 163xxxxx.
Ensure the shears are not stuck in the 'on' position by testing the activation mechanism.
If the shears remain activated, stop using them immediately to prevent unintended cuts.
The recall states that reprocessed shears may become stuck in the 'on' position, so they are not safe to use without checking the activation status.
Affected lot numbers include ranges like 162xxxxx, 163xxxxx, 164xxxxx, 165xxxxx, and 166xxxxx as listed in the recall notice.
The recall does not specify a return process, so contact Stryker directly for guidance on handling the affected units.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-0490-2026 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-0490-2026 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.