Waismed recalls

Waismed has 3 recalls on record with the FDA and USDA, the earliest in 2016 and the latest reported on 23 Jul 2025. 2 are still ongoing. The most frequent reason is sterility.

Total recalls3since 2016

Last 12 months0reported

Class I00% of total

Ongoing2latest 23 Jul 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 2Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why waismed is recalled

Sterility267%
Other Reasons133%

Product types

Medical Software267%
Surgical Instruments133%

By year

2025267%
2016133%

Ongoing waismed recalls

2 active

Reported	Class	Recall	Company	Reason	Where
23 Jul 2025Device	CLASS II	Nio-a NIO Intraosseous Device Adult recalled by Waismed	Waismed	Sterility	Nationwide
23 Jul 2025Device	CLASS II	NIO+ NIO Intraosseous Device Adult recalled by Waismed	Waismed	Sterility	Nationwide

All waismed recalls, newest first

3 total

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

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.