Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Stryker PenAdapt" Recalled by Stryker Instruments Div. of Stryker Corporation Due to During packaging verification testing, a failure occurred due...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Instruments Div. of Stryker Corporation directly.
Affected Products
Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smoke, particles, and body and casual fluids from the point of surgical activity during surgical procedures that use ESU for cutting and cauterizing.
Quantity: 35,310 unexpired units
Why Was This Recalled?
During packaging verification testing, a failure occurred due to cuts in the packaging potentially causing a breach in the sterile barrier. Additional testing identified microscopic aluminum metal shavings and foreign particles estimated in size to be between 0.01inches x 0.015 inches to 0.03 inches x 0.04 inches that were introduced during the manufacturing process and were sterilized within the
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Stryker Instruments Div. of Stryker Corporation
Stryker Instruments Div. of Stryker Corporation has 161 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report