Browse Device Recalls
25 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 25 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 25 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 10, 2019 | ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 | Software Security; The action is being initiated because of software security vulnerabilities wi... | Class II | Radiometer America Inc |
| Jul 3, 2018 | ABL800 analyzer, model numbers 393-800 and 393-801. | The analyzer software may cause a mis-match of patient demographics and test results when a certa... | Class II | Radiometer America Inc |
| Jul 2, 2018 | Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the foll... | From three incidents in Denmark and Sweden, comparison studies on patient blood samples carried o... | Class II | Radiometer America Inc |
| May 25, 2018 | ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX A... | The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take pla... | Class II | Radiometer America Inc |
| Oct 24, 2017 | ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of... | Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is ... | Class II | Radiometer America Inc |
| Sep 7, 2017 | AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood ga... | Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give i... | Class II | Radiometer America Inc |
| Jan 26, 2017 | The ABL800 Model#:All | Reports that the sample type "cord blood" has been changed into the two sample types "cord blood ... | Class II | Radiometer America Inc |
| Jan 26, 2017 | ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures p... | Reports that the sample type "cord blood" has been changed into the two sample types "cord blood ... | Class II | Radiometer America Inc |
| Nov 23, 2016 | AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335... | Design error when displaying additional information in the patient view window; error may result ... | Class II | Radiometer America Inc |
| Dec 29, 2015 | AQURE System; Model Number: 933-599. The AQURE System manages blood gas and ... | The AQURE System has a design error regarding sample type in which sample type may be specified f... | Class II | Radiometer America Inc |
| Nov 18, 2015 | TCM CombiM Modules 903-111 | Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that ca... | Class II | Radiometer America Inc |
| Jul 16, 2015 | Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873... | When the fixation ring is taken off the paper liner there is a potential for fractions of the pap... | Class II | Radiometer America Inc |
| Dec 8, 2014 | ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer th... | The ABL90 analyzer does not always use the most recent calibration data to calculate patient resu... | Class II | Radiometer America Inc |
| Oct 29, 2014 | Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL8... | Negative drift on QC during in-use lifetime of CREA membranes can be observed. | Class II | Radiometer America Inc |
| Oct 20, 2014 | HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are... | Batches of HemoCue Glucose 201 Microcuvettes show discoloration and provide results outside the s... | Class II | Radiometer America Inc |
| Jul 28, 2014 | RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data process... | Class II | Radiometer America Inc | |
| 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 |
| Jul 5, 2013 | pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. ... | RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on... | Class II | Radiometer America Inc |
| Jun 10, 2013 | pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, O... | RADIOMETER became aware that the regarded lot pO2 units 942-042R0971 were produced with inner sol... | 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 |
| Jul 5, 2012 | The ABL software version 6.12 for the ABL800 analyzer. The analyzers are inte... | A customer has reported an error on an ABL8xx configured to a Hospital Information System using t... | Class II | Radiometer America Inc |
| Jul 5, 2012 | The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyze... | A customer has reported an error on an ABL8xx configured to a Hospital Information System using t... | Class II | Radiometer America Inc |
| Jul 5, 2012 | ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for... | A customer has reported an error on an ABL8xx configured to a Hospital Information System using t... | Class II | Radiometer America Inc |
| Jun 6, 2006 | Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The ... | The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 in... | Class III | 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.