NIO NIO Adult+Recalls & reported problems

WaisMed Ltd · The NIO+ Adult is a single-use, automatic, spring-loaded, intraosseous sterile device with dual safety features for enhanced patient and caregiver safety. The NIO+ is packed in a rigid, low-profile case and can withstand extreme storage and usage conditions. After deployment, its built-in stabilizer base, in conjunction with a stand-alone NIO+ Fixation dressing, ensures that the needle is firmly secured · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Jun 5, 2025Class IIOpen, Classified
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Z-2119-2025 · Root cause: Process change control · Recall details · FDA record ↗

Device details

UDI-DI	`07290008325073`
Brand	NIO
Model	NIO Adult+
Company	WaisMed Ltd
Product code	FMI · Needle, Hypodermic, Single Lumen
Class	Class 2
FDA submission	K211968
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Aug 12, 2025

Device type (GMDN): Intraosseous infusion kit

A collection of sterile devices designed to perform an intraosseous (IO) infusion (i.e., an infusion directly into the bone's medullary cavity for the purpose of administering emergency medications and other fluids). It typically consists of a needle (possibly of a special design), an inserting handle, a scalpel, an infusion set, swabs and sutures. This device is used as an alternate to the preferred intravenous (IV) route when this cannot be established in a timely manner, typically during cardiac arrest, patients with respiratory failure or in shock, and when peripheral IV infusion is very difficult. This is a single-use device.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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