Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Nitinol Staple Recalled by TriMed Inc. Due to During a retrospective review of sterilization records, TriMed...
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 TriMed Inc. directly.
Affected Products
Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
Quantity: 532
Why Was This Recalled?
During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.
Where Was This Sold?
This product was distributed to 14 states: CA, FL, IL, KS, MN, MS, MO, NV, NJ, NC, PA, TX, UT, WA
About TriMed Inc.
TriMed Inc. has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report