Waismed Recalls
3 recalls on record · September 7, 2016 to July 23, 2025 · Medical Devices
Recalls by year
16
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 23, 2025Medical DevicesFDA
Waismed Ltd. recalls Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A P
Hazard: Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
July 23, 2025Medical DevicesFDA
Waismed Ltd. recalls Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A
Hazard: Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
September 7, 2016Medical DevicesFDA
Waismed Ltd recalls NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle i
Hazard: WaisMed received a report in which during the operation of the NIO-A, the needle was not released from the device as expected. The device was placed on the floor and after several minutes the needle was released spontaneously. NIO-A and the NIO-P models have the same activation mechanism. However, none of the affected lots of the NIO-A are distributed in the US, and thus the company is only recalling a single lot of NIO-P in the US.