FDA Devices recall · Reported July 23, 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 in adult patients, in emergent situations. Component: N/A
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Waismed Ltd. recalled Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105… - a moderate-severity action.
Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105… was recalled by Waismed Ltd. in July 23, 2025. Reason: Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deploy…. Check the official notice for the remedy. Verify recall #Z-2118-2025 with the FDA Devices before acting.
The recall
Waismed Ltd. issued this moderate-severity FDA Devices recall-Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deploy….
- Moderate
- severity level
- 7K units
- affected scope
- Class II
- classification
- July 23, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2118-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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 in adult patients, in emergent situations. Component: N/A
Reason for recall
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2118-2025 |
| Date reported | July 23, 2025 |
| Date initiated | June 5, 2025 |
| Recalling firm | Waismed Ltd. |
| Firm location | Herzliya, N/A |
| Affected scope | 7056 units (US) |
| 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, Germany, Portugal, Spain, Ukraine, Lithua… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2118-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026