PlainRecalls

Radiometer Medical ApS

Compiled from official public sources by the editorial team.

25 recalls on record · Latest: Apr 30, 2025

Radiometer Medical ApS Recall Insight

Radiometer Medical ApS appears on 25 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.025% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Apr 30, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 25 entries, severity tagging shows 0 critical, 25 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 25 of 25 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (25). The date window on this page runs from May 9, 2018 to Apr 30, 2025.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Apr 30, 2025

Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092 …

FDA Devices Moderate Jul 31, 2024

ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the …

FDA Devices Moderate Apr 26, 2023

AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and opera…

FDA Devices Moderate Jul 13, 2022

ABL800 Flex Analyzer Model Numbers 393-800 and 393-801

FDA Devices Moderate May 25, 2022

Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, …

FDA Devices Moderate Jun 23, 2021

E3800 PC Units (spare parts)

FDA Devices Moderate Jun 23, 2021

Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.

FDA Devices Moderate Jun 23, 2021

Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.

FDA Devices Moderate Jun 2, 2021

PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler product line for collection of art…

FDA Devices Moderate Jul 15, 2020

Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the follow…

FDA Devices Moderate Jul 15, 2020

Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available as ABL837. Th…

FDA Devices Moderate Jul 8, 2020

ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, n…

FDA Devices Moderate Jul 8, 2020

ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near pa…

FDA Devices Moderate Jun 10, 2020

safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1

FDA Devices Moderate Jun 10, 2020

safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1

FDA Devices Moderate Jun 10, 2020

safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1

FDA Devices Moderate Jun 3, 2020

ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologist…

FDA Devices Moderate Jun 3, 2020

ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technolog…

FDA Devices Moderate May 6, 2020

ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004

FDA Devices Moderate Apr 29, 2020

ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care set…

FDA Devices Moderate Apr 29, 2020

ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, …

FDA Devices Moderate Apr 29, 2020

TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-5…

FDA Devices Moderate Apr 15, 2020

ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu…

FDA Devices Moderate Feb 5, 2020

AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intende…

FDA Devices Moderate May 9, 2018

AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices and operato…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Radiometer Medical ApS with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.