CLASS II Device recall · Reported 7 Sep 2016 · FDA Enforcement Report

Nio-a / Nio-p is an instant IO access device comprises recalled

Waismed is recalling Nio-a / Nio-p is an instant IO access device comprises housing with spring load mechanism, distributed in California, Louisiana, Texas, Wisconsin. The recall was initiated on 18 Aug 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1620005

Quantity recalled50

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2680-2016
FDA event ID: 75008
Recalling firm: Waismed, Rosh Haayin, N/A
Classification: Class II
Status: Terminated
Recall initiated: 18 Aug 2016
FDA classified: 27 Aug 2016
Reported: 7 Sep 2016
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

18 Aug 2016	Recall initiated by company
27 Aug 2016	Classified by FDA	+9 days
7 Sep 2016	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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

California Louisiana Texas Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

1620005

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Waismed

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23 Jul 2025Device	CLASS II	Nio-a NIO Intraosseous Device Adult recalled by Waismed	Waismed	Device Malfunction	Nationwide
23 Jul 2025Device	CLASS II	NIO Intraosseous Device Adult recalled by Waismed	Waismed	Device Malfunction	Nationwide

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