CLASS II ONGOING Device recall · Reported 23 Jul 2025 · FDA Enforcement Report

Nio-a NIO Intraosseous Device Adult recalled by Waismed

Waismed is recalling Nio-a NIO Intraosseous Device Adult, distributed nationwide in the US. The recall was initiated on 5 Jun 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 0 7290008325059 Lot number: 2440043, 2440045, 2540046, 2540047

Quantity recalled7056 units (US)

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-2118-2025
FDA event ID: 97061
Recalling firm: Waismed, Herzliya, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 5 Jun 2025
FDA classified: 17 Jul 2025
Reported: 23 Jul 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Medical Software

Timeline

5 Jun 2025	Recall initiated by company
17 Jul 2025	Classified by FDA	+42 days
23 Jul 2025	Published in enforcement report	+6 days

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

Reason for recall

Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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, Lithuania, Chile, Poland, Germany, New Zealand, Montenegro, Switzerland, Argentina, Poland, Austria, Sweden, United Kingdom, Italy, France, Romania, Netherlands, Croatia, Lithuania, New Zealand, Japan, Cyprus, and Israel.

Nationwide North Carolina

Questions about this recall

Why was it recalled?

Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.

Which lots are affected?

UDI: 0 7290008325059 Lot number: 2440043, 2440045, 2540046, 2540047

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.

Other products in this recall event

1 other product · FDA event 97061

This product is part of a recall event; the main page for the event is NIO Intraosseous Device Adult recalled by Waismed.

Reported	Class	Recall	Company	Reason	Where
23 Jul 2025	CLASS II	NIO Intraosseous Device Adult recalled by Waismed	Waismed	Device Malfunction	Nationwide

More recalls from Waismed

All 3

Reported	Class	Recall	Company	Reason	Where
23 Jul 2025Device	CLASS II	NIO Intraosseous Device Adult recalled by Waismed	Waismed	Device Malfunction	Nationwide
7 Sep 2016Device	CLASS II	Nio-a / Nio-p is an instant IO access device comprises recalled	Waismed	Other	4 states

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