Unomedical A/S recalls

Unomedical A/S has 6 recalls on record with the FDA and USDA, the earliest in 2022 and the latest reported on 25 Sep 2024. 5 are still ongoing. The most frequent reason is device malfunction.

Total recalls6since 2022

Last 12 months0reported

Class I350% of total

Ongoing5latest 25 Sep 2024

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 3 50%Class II 3 50%Class III 0 0%

Why unomedical a/s is recalled

Product types

Infusion Pumps583%
Heart & Vascular Devices117%

By year

2024233%
2023350%
2022117%

Ongoing unomedical a/s recalls

5 active

Reported	Class	Recall	Company	Reason	Where
25 Sep 2024Device	CLASS II	VariSoft Infusion Set, Single Use recalled by Unomedical A/S	Unomedical A/S	Packaging Defects	Nationwide
24 Apr 2024Device	CLASS II	Neria Soft Infusion Set, Product recalled by Unomedical A/S	Unomedical A/S	Other	Nationwide
29 Nov 2023Device	CLASS I	VariSoft infusion set recalled by Unomedical A/S	Unomedical A/S	Device Malfunction	Nationwide
29 Nov 2023Device	CLASS I	VariSoft infusion set recalled by Unomedical A/S	Unomedical A/S	Device Malfunction	Nationwide
29 Nov 2023Device	CLASS I	VariSoft infusion set recalled by Unomedical A/S	Unomedical A/S	Device Malfunction	Nationwide

All unomedical a/s recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
25 Sep 2024Device	CLASS II	VariSoft Infusion Set, Single Use recalled by Unomedical A/S	Unomedical A/S	Packaging Defects	Nationwide
24 Apr 2024Device	CLASS II	Neria Soft Infusion Set, Product recalled by Unomedical A/S	Unomedical A/S	Other	Nationwide
29 Nov 2023Device	CLASS I	VariSoft infusion set recalled by Unomedical A/S	Unomedical A/S	Device Malfunction	Nationwide
29 Nov 2023Device	CLASS I	VariSoft infusion set recalled by Unomedical A/S	Unomedical A/S	Device Malfunction	Nationwide
29 Nov 2023Device	CLASS I	VariSoft infusion set recalled by Unomedical A/S	Unomedical A/S	Device Malfunction	Nationwide
5 Oct 2022Device	CLASS II	Autosoft 90, model numbers 1000282 recalled by Unomedical A/S	Unomedical A/S	Other	CA

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.