Browse Device Recalls
28 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 28 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 28 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 21, 2025 | Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radio... | ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 a... | Class II | Radiometer Medical ApS |
| May 31, 2024 | ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers a... | Issue with analyzer when the pH of the calibration solution decreases during the in-use period po... | Class II | Radiometer Medical ApS |
| Mar 8, 2023 | AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The... | Due to potential software issue that may result in patient mix-up information. | Class II | Radiometer Medical ApS |
| May 18, 2022 | ABL800 Flex Analyzer Model Numbers 393-800 and 393-801 | There is a potential for sporadic incidents of positive and negative biases for analyzer systems ... | Class II | Radiometer Medical ApS |
| Apr 8, 2022 | Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU elect... | Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product. | Class II | Radiometer Medical ApS |
| Apr 14, 2021 | Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is ... | Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. | Class II | Radiometer Medical ApS |
| Apr 14, 2021 | Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also ... | Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. | Class II | Radiometer Medical ApS |
| Apr 14, 2021 | E3800 PC Units (spare parts) | Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. | Class II | Radiometer Medical ApS |
| Mar 26, 2021 | PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electro... | Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. The issue relates to ... | Class II | Radiometer Medical ApS |
| May 26, 2020 | Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 3... | Potential risk of patient mix-up on analyzers due to software issues. | Class II | Radiometer Medical ApS |
| May 26, 2020 | Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 3... | Potential risk of patient mix-up on analyzers due to software issues. | Class II | Radiometer Medical ApS |
| May 11, 2020 | ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Pr... | Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, ... | Class II | Radiometer Medical ApS |
| May 11, 2020 | ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 0570069393841... | Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, ... | Class II | Radiometer Medical ApS |
| Mar 17, 2020 | safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1 | The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulti... | Class II | Radiometer Medical ApS |
| Mar 17, 2020 | safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1 | The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulti... | Class II | Radiometer Medical ApS |
| Mar 17, 2020 | safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1 | The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulti... | Class II | Radiometer Medical ApS |
| Mar 10, 2020 | ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of wh... | Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ... | Class II | Radiometer Medical ApS |
| Mar 6, 2020 | ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004 | Through internal investigation is has been determined that an incorrect component was used within... | Class II | Radiometer Medical ApS |
| Feb 20, 2020 | TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor mo... | Reports have been received about the transcutaneous monitoring system display flickering or monit... | Class II | Radiometer Medical ApS |
| Feb 3, 2020 | ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4M... | The firm received reports of occurrences where the barcode reader misinterpreted the contents of... | Class II | Radiometer Medical ApS |
| Feb 3, 2020 | ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intende... | The firm received reports of occurrences where the barcode reader misinterpreted the contents of... | Class II | Radiometer Medical ApS |
| Nov 21, 2019 | ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): ... | The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcompone... | Class II | Radiometer Medical ApS |
| Nov 21, 2019 | ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R052... | The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcompone... | Class II | Radiometer Medical ApS |
| Aug 8, 2019 | AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx On... | The firm has become aware that there is a potential problem relating to the blood gas and immunoa... | Class II | Radiometer Medical ApS |
| Feb 27, 2018 | AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system i... | There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may res... | Class II | Radiometer Medical ApS |
| Oct 15, 2013 | ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark ... | RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative b... | Class II | Radiometer America Inc |
| Nov 27, 2012 | TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, ... | RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Claus... | Class II | Radiometer America Inc |
| Oct 8, 2012 | Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intend... | RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The en... | Class II | Radiometer America Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.