Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A P
Summary
The FDA issued a Class II for Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Num by Waismed Ltd.. Reason: Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion..
Details
Source
Device Recall
External ID
Z-2119-2025
Action Date
2025-07-23
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Lot Code: UDI: 07290008325073 Lot number: 2440044
Quantity Affected: 516 units (US)
Reason for Recall
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-05
Company
Herzliya, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 109 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Waismed Ltd. has 3 FDA actions in our database, including 2 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Waismed Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Waismed Ltd. have FDA actions?
Waismed Ltd. has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2119-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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