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TGA Action ID	RC-2025-RN-01040-1
Type of Product	Medical Device
Product Name/Description	NICO Myriad Handpiece Catalogue Numbers: NN-8501, NN-8502, NN-8503, NN-8504, NN-8506, NN-8508, NN-8518 Lot Numbers: 37CC7849, 37DJ1045, 37BA1106, 37HJ1102, 37AC5393, 37CJ2214, 37CB4111, 37EB6004, 37LA0729, 37DJ1049, 37IJ1009, 37KB3681, 37HB9031, 37IC6878, 37GA4637 GTIN: 00816744025014, 00816744025021, 00816744025038, 00816744025045, 00816744025069, 00816744025083, 00816744025182
ARTG Number	193318, 307159
Action Type	Recall
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	The tape used to secure NICO components within the packaging contains latex, despite the products being labelled as latex-free. Latex exposure may pose a health risk to individuals with latex allergies. If a latex sensitised individual comes into direct and sustained contact with the tape, there is a potential for an allergic reaction which may include localised skin irritation. More serious allergic reactions such as hives, swelling, respiratory distress, or anaphylaxis could occur. There have been zero complaints or adverse events reported for this problem.
Instructions for Customers/Users	Customers are to: - Immediately check inventory and dispose affected product. - Contact local Stryker representative to coordinate the replacement of any affected product. This action has been finalised on 19/3/2026.
Action Commencement Date	10/12/2025
Responsible Entity	Stryker Australia Pty Ltd
Contact Information	0437 112 648 - Stryker Quality and Post Market