Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PARPARELLA-TYPE VENT TUBE Recalled by Gyrus Acmi, Incorporated Due to One lot of tympanostomy tubes were manufactured with...
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 Gyrus Acmi, Incorporated directly.
Affected Products
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
Quantity: 10 boxes/60 units
Why Was This Recalled?
One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.
Where Was This Sold?
Worldwide distribution: USA state of Kansas and country of Korea.
About Gyrus Acmi, Incorporated
Gyrus Acmi, Incorporated has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report