Z-2119-2025Class II

Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software...

Name: Z-2119-2025 Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software...
Creator: Waismed Ltd.
Published: 2025-06-05
License: https://open.fda.gov/license/

Waismed Ltd. / initiated 2025-06-05 / Open, Classified / root cause: manufacturing process

FDA source

Waismed Ltd. began a recall of Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a... on 2025-06-05. FDA classified it as Class II and gives the reason as "Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2119-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-05
Posted: 2025-07-17
Recalling firm: Waismed Ltd.
Product: Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: On June 05, 2025, WaisMed issued an "Urgent: Medical Device Recall" notification to affected consignees via E-Mail. WaisMed asked consignees to take the follow actions: 1. Healthcare providers should immediately discontinue use of affected devices and consider alternative intraosseous access products to ensure continuity of patient care without compromising treatment timelines in critical situations. 2. Immediately discontinue, quarantine and remove all NIO A and NIO+ devices from the affected lots from all points of use, including emergency kits, crash carts, ambulances, and clinical storage areas. 3. Verify your inventory against the specific lot numbers listed in this recall notice to identify all affected products. 4. Share and post this Product Recall letter within your facility network. 5. Forward to any customers you may have distributed the product to ensure awareness. 6. Ensure the contents of this Product Recall are read and understood by those within your organization. 7. Please complete the attached Recall Acknowledgement and Receipt Form and return it to: [email protected] or mail to: Waismed Ltd. 10 Amal St. Afek Industrial Park, Rosh Ha'yin 4809234, Israel. Any questions directly associated with this recall should be directed to the: Recall Coordinator or International Director Quality and Regulatory Affairs via email: [email protected], phone: +972-9-9517444 or website: safeguardmedial.com.
Quantity in commerce: 516 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, 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.
Product codes and lots: Lot Code: UDI: 07290008325073 Lot number: 2440044

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2119-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2118-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-23	2025-07-17
Z-2119-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-23	2025-07-17

Product code FMI

K211968Class IINIO+ AdultWaismed, Ltd. / cleared 2021-07-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)