Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GYRUS ACMI Recalled by Gyrus Acmi, Incorporated Due to lack of sterility assurance
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
GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.
Quantity: 100 boxes of 6 units
Why Was This Recalled?
lack of sterility assurance
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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