Reprocessed Agilis Steerable Introducer: indicated for… recallZ-0090-2019 · Sterilmed, Inc. · initiated Sep 17, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Sterilmed, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
FDA root cause category: Material/Component Contamination
What the company is doing
Sterilmed notified customers on about 09/17/2018, via URGENT MEDICAL DEVICE RECALL letter sent via UPS next day. Instructions included examine inventory for affected devices, remove and return affected devices to Stericycle (3rd party processor), provide recall information to appropriate personnel at the facility, and complete and return the Business Reply Form to Stericycle. For questions, contact Sterilmed's Customer Care Team at (888) 541-0078, Monday through Friday from 7:00 AM to 5:00 PM CST.
Recall details
- Recall number
- Z-0090-2019
- Status
- Terminated
- Initiated by the company
- Sep 17, 2018
- Posted by the FDA
- Oct 9, 2018
- Recalling firm
- Sterilmed, Inc.
- Quantity
- 218 units
- Product code
- PNH
- FDA submissions
- K152090
- Distribution
- U.S. Nationwide distribution in the states of CA, CO, MN, and WA.
Product description
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
Code information (models, lots, serial numbers)
All lots with expiration dates prior to 2019-06-08 of the following: (a) Product Code STJ408309, GTIN 10888551044912 (b) Product Code STJ408310, GTIN 10888551044929 (c) Product Code STJ408324, GTIN 10888551044950
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- NA STJ408310Sterilmed, Inc. · Reprocessed catheter introducer1 recall3 reports
- NA STJ408309Sterilmed, Inc. · Reprocessed catheter introducer1 recall0 reports
- NA STJG408324Sterilmed, Inc. · Reprocessed catheter introducer1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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