Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** Recalled by Oto Med Inc Due to During internal Age Testing, holes were found in...
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 Oto Med Inc directly.
Affected Products
Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
Quantity: 5,092 devices
Why Was This Recalled?
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Oto Med Inc
Oto Med Inc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report