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All product recalls associated with Opti Medical Systems Inc.
Total Recalls
1000
Past Year
1000
Class I (Serious)
143
Most Recent
Jan 2026
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Incorrect results/stability failure; Actual device stability studies show sodium and chloride sensors age differently than anticipated when stored at the high end of labeled storage, therefore subsequent measurements give results outside the allowed error allowance before the 6 month expiration date shown on the device.
Sterility of device may be compromised due to breach in sterile barrier.
This recall involves 190 Radial Brake Master Cylinders used on off-road motorcycles. The brake cylinders have an "A" or "B" code on the underside of the lever's pivot bolt. The Magura logo is printed on the cylinder. Brake cylinders without the "A" or "B" markings are not included in this recall.