Radiometer Medical ApS recalls

Radiometer Medical ApS has 24 recalls on record with the FDA and USDA, the earliest in 2018 and the latest reported on 30 Apr 2025. 8 are still ongoing.

Total recalls24since 2018

Last 12 months0reported

Class I00% of total

Ongoing8latest 30 Apr 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 1 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 24 100%Class III 0 0%

Why radiometer medical aps is recalled

Product types

By year

202514%
202314%
202228%
2021417%
20201563%
201814%

Ongoing radiometer medical aps recalls

8 active

Reported	Class	Recall	Company	Reason	Where
30 Apr 2025Device	CLASS II	Radiometer ABL90 Series - Radiometer ABL90 FLEX recalled	Radiometer Medical ApS	Device Malfunction	49 states
26 Apr 2023Device	CLASS II	Aqure REF 933-599 Software Versions 2.5.2 recalled	Radiometer Medical ApS	Packaging Defects	Nationwide
13 Jul 2022Device	CLASS II	ABL800 Flex Analyzer recalled by Radiometer Medical ApS	Radiometer Medical ApS	Other	Nationwide
25 May 2022Device	CLASS II	Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL recalled	Radiometer Medical ApS	Sterility	Nationwide
23 Jun 2021Device	CLASS II	Radiometer ABL90 Flex Plus Analyzer with E3800 PC units recalled	Radiometer Medical ApS	Other	Nationwide
23 Jun 2021Device	CLASS II	Radiometer ABL90 FLEX Analyzer with E3800 PC units recalled	Radiometer Medical ApS	Other	Nationwide

All radiometer medical aps recalls, newest first

24 total

Reported	Class	Recall	Company	Reason	Where
30 Apr 2025Device	CLASS II	Radiometer ABL90 Series - Radiometer ABL90 FLEX recalled	Radiometer Medical ApS	Device Malfunction	49 states
26 Apr 2023Device	CLASS II	Aqure REF 933-599 Software Versions 2.5.2 recalled	Radiometer Medical ApS	Packaging Defects	Nationwide
13 Jul 2022Device	CLASS II	ABL800 Flex Analyzer recalled by Radiometer Medical ApS	Radiometer Medical ApS	Other	Nationwide
25 May 2022Device	CLASS II	Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL recalled	Radiometer Medical ApS	Sterility	Nationwide
23 Jun 2021Device	CLASS II	Radiometer ABL90 Flex Plus Analyzer with E3800 PC units recalled	Radiometer Medical ApS	Other	Nationwide
23 Jun 2021Device	CLASS II	Radiometer ABL90 FLEX Analyzer with E3800 PC units recalled	Radiometer Medical ApS	Other	Nationwide
23 Jun 2021Device	CLASS II	E3800 PC Units (spare parts) recalled by Radiometer Medical ApS	Radiometer Medical ApS	Other	Nationwide
2 Jun 2021Device	CLASS II	956-518 PICO70 w/o needle recalled by Radiometer Medical ApS	Radiometer Medical ApS	Sterility	Nationwide
15 Jul 2020Device	CLASS II	Blood gases (PCO2, PO2) and blood pH test system recalled	Radiometer Medical ApS	Packaging Defects	46 states
15 Jul 2020Device	CLASS II	Blood gases (PCO2, PO2) and blood pH test system recalled	Radiometer Medical ApS	Packaging Defects	46 states
8 Jul 2020Device	CLASS II	ABL80-Flex-393-839 Box Label recalled by Radiometer Medical ApS	Radiometer Medical ApS	Other	Nationwide
8 Jul 2020Device	CLASS II	ABL80-Flex Co-ox 393-841 Box Label recalled by Radiometer Medical ApS	Radiometer Medical ApS	Other	Nationwide
10 Jun 2020Device	CLASS II	safeCLINITUBES Blood Sampler recalled by Radiometer Medical ApS	Radiometer Medical ApS	Other	38 states
10 Jun 2020Device	CLASS II	safeCLINITUBES Blood Sampler recalled by Radiometer Medical ApS	Radiometer Medical ApS	Other	38 states
10 Jun 2020Device	CLASS II	safeCLINITUBES Blood Sampler recalled by Radiometer Medical ApS	Radiometer Medical ApS	Other	38 states
3 Jun 2020Device	CLASS II	Abl90 Flex Plus recalled by Radiometer Medical ApS	Radiometer Medical ApS	Other	Nationwide
3 Jun 2020Device	CLASS II	ABL90 FLEX recalled by Radiometer Medical ApS	Radiometer Medical ApS	Other	Nationwide
6 May 2020Device	CLASS II	ABL800 FLEX recalled by Radiometer Medical ApS	Radiometer Medical ApS	Other	CA
29 Apr 2020Device	CLASS II	TCM4 Base unit recalled by Radiometer Medical ApS	Radiometer Medical ApS	Other	Nationwide
29 Apr 2020Device	CLASS II	ABL90 FLEX Analyzer recalled by Radiometer Medical ApS	Radiometer Medical ApS	Packaging Defects	Nationwide
29 Apr 2020Device	CLASS II	ABL90 Flex Plus Analyzer recalled by Radiometer Medical ApS	Radiometer Medical ApS	Packaging Defects	Nationwide
15 Apr 2020Device	CLASS II	ABL800 FLEX recalled by Radiometer Medical ApS	Radiometer Medical ApS	Packaging Defects	Nationwide
5 Feb 2020Device	CLASS II	Aqure basic sytem, Flexlink recalled by Radiometer Medical ApS	Radiometer Medical ApS	Potency & Assay	Nationwide
9 May 2018Device	CLASS II	Aqure, Software version 2.3.0 and 2.3.1 Product Usage: The Aqure recalled	Radiometer Medical ApS	Packaging Defects	Nationwide

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.