Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
3/8 STR CONN Recalled by LivaNova USA Inc. Due to The firm has identified through internal tests that...
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 LivaNova USA Inc. directly.
Affected Products
3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292
Quantity: 860 units
Why Was This Recalled?
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period.
Where Was This Sold?
This product was distributed to 44 states: AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, LA, ME, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, DC
About LivaNova USA Inc.
LivaNova USA Inc. has 28 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report