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 device malfunction.

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

0Nov '24 0 0 0Feb 0 0 0May 0 2 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

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

Why waismed is recalled

Device Malfunction267%
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	Device Malfunction	Nationwide
23 Jul 2025Device	CLASS II	NIO Intraosseous Device Adult recalled by Waismed	Waismed	Device Malfunction	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	Device Malfunction	Nationwide
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

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.