PlainRecalls

Radiometer Medical ApS

Compiled from official public sources by the publisher.

25 recalls on record · Latest: Apr 30, 2025

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Agency notice ledger

Federal filing book Radiometer Medical ApS MID-BOOK · SINGLE-AGENCY

#661 of 14,151 · 25 notices · 0.024% archive

  • BOOK 25 notices
  • RANK #661 of 14,151
  • SHARE 0.024% archive
  • AGENCY FDA Devices (25)
  • CAT medical devices
  • CATS 1 category
  • LATEST Apr 30, 2025
  • PHOTO Asp Global, LLC. dba…

Nearest notice-volume peer: Asp Global, LLC. dba Anatomy Supply Partners, LLC. (0 notice gap)

Radiometer Medical ApS accounts for about 0.024% of the 104,423-notice archive on 25 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Radiometer Medical ApS's standing among 14,151 recalling firms

Radiometer Medical ApS ranks 661st of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Radiometer Medical ApS vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

25 661st of 14151 higher than 13,484 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Radiometer Medical ApS in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Radiometer Medical ApS holds about 0.024% of archive notices alongside 25 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
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 The Radiometer ABL90 Series is a portable, automated analyzer for use in the laboratory environment, near patients or point-of-care settings.
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 parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) " In vitro testing of samples of expired air for the parameters pO2 and pCO2 " In vitro testing of pleura samples for the pH parameter.
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 operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell user
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, CE
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 arterial samples for pH, blood gas, oximetry, electrolyte and metabolite analysis. Model Number/Product Description: 956-518 PICO70 w/o needle; 956-519 PICO70 w/o needle; 956-522 PICO70 22G x 25 mm; 956-525 PICO70 22G x 32 mm; 956-529 PICO70 23G x 16 mm; 956-533 PICO70 23G x 25 mm; 956-534 PICO70 23G x 32 mm; 956-547 PICO70 25G x 16 mm;
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 following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and ABL800Basic. The FlexQ module is optional and can be added to all models and configurations.
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. The FlexQ module is optional and can be added to all models and configurations.
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, near patient or point-of-care setting.
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 patient or point-of-care setting.
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 technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
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 technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
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 setting.
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, near patient or point-of-care setting.
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 (902-564), TOSCA (903-044) and CombiM (903-111) - Product Usage: It is indicated for use on pediatrics and adults.
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, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) In vitro testing of samples of expired air for the parameters pO2 and pCO2 In vitro testing of pleura samples for the pH parameter.0693938004 and 393-801/05700693938011 - Product Usage:
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 intended to let you manage analytical devices and operator profiles.
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 operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets the user send commands to selected devices. The system uses data related to the performance of devices, to tell use

Radiometer Medical ApS holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Asp Global, LLC. dba Anatomy Supply Partners, LLC. 25 Carefusion 25 Radiometer America Inc 25 Allergan PLC 26

Frequently Asked Questions

How many federal recall notices name Radiometer Medical ApS? ▼
PlainRecalls indexes 25 distinct federal recall events naming Radiometer Medical ApS, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Radiometer Medical ApS sit among other recalling firms? ▼
Radiometer Medical ApS ranks #661 of 14,151 by distinct recall-event count among 14,151 firms in this archive (95th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Radiometer Medical ApS's notices? ▼
FDA Devices accounts for 25 of this firm's 25 indexed notices.
What product category dominates Radiometer Medical ApS's filing book? ▼
Filings for Radiometer Medical ApS span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Radiometer Medical ApS: 25 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Radiometer Medical ApS; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026