Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 7, 2016
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.
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Waismed Ltd recalled NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism… - a moderate-severity action.
NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism… was recalled by Waismed Ltd in September 7, 2016. Reason: WaisMed received a report in which during the operation of the NIO-A, the needle was not released from the de…. Check the official notice for the remedy. Verify recall #Z-2680-2016 with the FDA Devices before acting.
The recall
Waismed Ltd issued this moderate-severity FDA Devices recall-WaisMed received a report in which during the operation of the NIO-A, the needle was not released from the de….
- Moderate
- severity level
- 50 units
- affected scope
- Class II
- classification
- September 7, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2680-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2680-2016) was formally reported on September 7, 2016, with the manufacturer initiating the action on August 18, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Waismed Ltd is listed as the recalling firm, operating out of Rosh Haayin, N/A. Federal records list the affected scope as 50.
The documented reason for this recall is: 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 spontan… Distribution data in the federal record shows the product reached: WI, TX, CA, LA and the following countries: UK, Spain, Poland, Israel, Czech Republic, France, Belgium, Denmark, Italy, Cyprus, Austria, Greece, Slovenia, Australia, Germany, Estonia, New Zealand, Switzerland, Costa Ric…. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
50
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2680-2016 |
| Date reported | September 7, 2016 |
| Date initiated | August 18, 2016 |
| Recalling firm | Waismed Ltd |
| Firm location | Rosh Haayin, N/A |
| Affected scope | 50 |
| Distribution | WI, TX, CA, LA and the following countries: UK, Spain, Poland, Israel, Czech Republic, France, Belgium, Denmark, Italy, Cyprus, Austria, Greece, Slovenia, Australia, Germany, Estonia, New Zealand, Switzerland, Costa Rica, Guatemala, Canada… |
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-2680-2016) 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.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Waismed Ltd. Units affected: 50.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 7, 2016. Severity: Moderate. Recall number: Z-2680-2016.
Where was the recalled product distributed? ▼
Distribution: WI, TX, CA, LA and the following countries: UK, Spain, Poland, Israel, Czech Republic, France, Belgium, Denmark, Italy, Cyprus, Austria, Greece, Slovenia, Australia, Germany, Estonia, New Zealand, Switzerland, Costa Rica, Guatemala, Canada, Malaysia, Poland, Singapore, Lithuania, Romania.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2680-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 7, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.