NIO-A / NIO-P is an instant IO access device comprises housing with… — Class II medical device recall Z-2680-2016
Terminated recall by Waismed Ltd, reported 2016-09-07, distributed in CA, LA, TX, WI. WaisMed received a report in which during the operation of the NIO-A, the needle was not released from the dev
| Recall number | Z-2680-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Waismed Ltd, Rosh Haayin, N/A, Israel |
| Recall initiated | 2016-08-18 |
| Classified | 2016-08-27 |
| Reported by FDA | 2016-09-07 |
| Terminated | 2016-12-05 |
| Distributed | CA, LA, TX, WI |
| Countries outside the US | AT, AU, BE, CA, CH, CR, CY, CZ, DE, DK, EE, ES, FR, GB, GR, GT, IL, IT, LT, MY, NZ, PL, RO, SG, SI |
| Quantity | 50 |
Product
NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle into the bone marrow of a patient and allows connection of syringe or IV administration set. The NIO-A is intended for adults above 12 years old and the NIO-P is intended for pediatric patients 3 - 12 years of age.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2680-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.