Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters Recalled by Sterilmed, Inc. Due to Reprocessed Agilis Steerable Introducers may not meet endotoxin...
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 Sterilmed, Inc. directly.
Affected Products
Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/71 cm length), Product Code STJ408324
Quantity: 218 units
Why Was This Recalled?
Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sterilmed, Inc.
Sterilmed, 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