Device recall: Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Prod
Waismed Ltd. (Herzliya, N/A) initiated this device recall on 5 Jun 2025; FDA lists 2 product records under event 97061, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Waismed Ltd. has 2 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Waismed Ltd., Herzliya, N/A, Israel.
Reason for recall
"Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion."
Distribution
"Worldwide distribution: US (nationwide) to state of: NC and OUS (international) countries of: Slovenia, Australia, Brazil, Estonia, South Africa, U. Arab Emirate, Greece, Panama, Singapore, Italy,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2118-2025 | Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous access device supplied Sterile and single use. Indicated for Intra-osseous access to the Proximal humerus and Proximal Tibia… | 7056 units (US) | Class II | Ongoing | 23 Jul 2025 |
| Z-2119-2025 | Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to the Proximal humerus and Proximal Tibia in… | 516 units (US) | Class II | Ongoing | 23 Jul 2025 |
Context
Other enforcement events for Waismed Ltd.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 18 Aug 2016 | NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle i (75008) | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution: US (nationwide) to state of: NC and OUS (international) countries of: Slovenia, Australia, Brazil, Estonia, South Africa, U. Arab Emirate, Greece, Panama, Singapore, Italy,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.