Medical DeviceJul 23, 2025
NIO+ NIO Intraosseous Device Adult recall — FDA Z-2119-2025
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Class IIFDA: OngoingWaismed Ltd.
Recall history in this database
Classification mix: Class II: 2.
Medical DeviceJul 23, 2025
NIO-A NIO Intraosseous Device Adult recall — FDA Z-2118-2025
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Class IIFDA: OngoingWaismed Ltd.
Understanding this recall history
This page summarizes recall records in which the official source identifies Waismed Ltd. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.