Browse Device Recalls
530 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 530 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 530 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 26, 2021 | Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, ... | Two software issues have been identified related to pressure increase in the device: The first is... | Class II | Philips Respironics, Inc. |
| Jul 26, 2021 | Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B | Two software issues have been identified related to pressure increase in the device: The first is... | Class II | Philips Respironics, Inc. |
| Jul 26, 2021 | Alinity ci-series System Control Module clinical chemistry and immunoassay an... | Due to potential performance issues with software version 3.2.3 and earlier. Performance issues ... | Class II | Abbott Laboratories |
| Jul 26, 2021 | Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15... | Two software issues have been identified related to pressure increase in the device: The first is... | Class II | Philips Respironics, Inc. |
| Jul 26, 2021 | Trilogy Evo Universal, Product number DS2000X11B | Two software issues have been identified related to pressure increase in the device: The first is... | Class II | Philips Respironics, Inc. |
| Jul 6, 2021 | Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the ... | Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days... | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 6, 2021 | Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic... | Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days... | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 6, 2021 | Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the ... | Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days... | Class II | Siemens Healthcare Diagnostics, Inc |
| Jun 8, 2021 | Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #... | intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calib... | Class II | Terumo Cardiovascular Systems Corporation |
| May 3, 2021 | VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemi... | Ortho investigated and confirmed the potential for unexpected failed calibration, and condition c... | Class II | Ortho-Clinical Diagnostics, INc. |
| Mar 29, 2021 | Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catal... | Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across ... | Class II | Randox Laboratories Ltd. |
| Mar 16, 2021 | VIDAS¿ CMV IgM 30 Tests | bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM... | Class II | Biomerieux Inc |
| Feb 26, 2021 | CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable,... | Erroneously high FeNO levels which may contribute to premature discontinuation of effective asthm... | Class II | CAIRE DIAGNOSTICS INC |
| Feb 8, 2021 | Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2 | Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correctio... | Class II | Siemens Healthcare Diagnostics, Inc |
| Nov 17, 2020 | Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.... | A software error was detected within software version 1.3.4 for the Tempus LS device. When exitin... | Class II | Remote Diagnostic Technologies Ltd. |
| Nov 9, 2020 | icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended fo... | Due to a potential software issue, the display may show the incorrect continuous cardiac output (... | Class II | ICU Medical, Inc. |
| Nov 6, 2020 | Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usa... | Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the... | Class II | Roche Diagnostics Operations, Inc. |
| Aug 27, 2020 | Tina-quant Complement C4 ver.2, Catalog 05991994190 | Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for... | Class III | Roche Diagnostics Operations, Inc. |
| Aug 27, 2020 | Albumin Gen.2, Catalog 05166861190 | Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for... | Class III | Roche Diagnostics Operations, Inc. |
| Aug 19, 2020 | Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_... | Calibration offset between the central CT image plane and the external RT lasers has been set aut... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 7, 2020 | Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG P... | Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, ... | Class II | Tosoh Bioscience Inc |
| Aug 7, 2020 | Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Dia... | Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, ... | Class II | Tosoh Bioscience Inc |
| Jul 17, 2020 | VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6... | The reagent bottles may be swapped within the reagent pack, which may lead to false negative resu... | Class II | Ortho Clinical Diagnostics |
| Jul 17, 2020 | VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog numbe... | The reagent bottles may be swapped within the reagent pack, which may lead to false negative resu... | Class II | Ortho Clinical Diagnostics |
| Jul 16, 2020 | BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; ... | Incorrect manufacturer calibration | Class II | Brainlab AG |
| Jul 16, 2020 | BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 U... | Incorrect manufacturer calibration | Class II | Brainlab AG |
| Jun 5, 2020 | Atellica CH Chemistry Calibrator | Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemi... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 5, 2020 | ADVIA Chemistry Calibrator | Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemi... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 10, 2020 | VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468 | The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations. | Class III | Ortho Clinical Diagnostics |
| Feb 20, 2020 | Expression MR400 MRI Patient Monitoring System Model Number: 866185 Softwa... | Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incor... | Class II | Philips North America, LLC |
| Feb 14, 2020 | Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 1109... | The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibratio... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 29, 2020 | ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 -... | Electrolyte reference reagent, used for clinical laboratory testing to determine CO2 in human ser... | Class II | Beckman Coulter Inc. |
| Dec 20, 2019 | ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. ... | Firm has received customer complaints regarding failed calibrations and increased imprecision of ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 10, 2019 | VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit | Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which ... | Class II | bioMerieux, Inc. |
| Nov 19, 2019 | Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product ... | Atellica CH: The Atellica¿ CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 19, 2019 | ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calib... | Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-D... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 28, 2019 | Genius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063 | The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua... | Class II | Cardinal Health 200, LLC |
| Oct 28, 2019 | Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013 | The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua... | Class II | Cardinal Health 200, LLC |
| Oct 28, 2019 | Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000 | The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua... | Class II | Cardinal Health 200, LLC |
| Oct 28, 2019 | Genius 2 Tympanic Thermometer Private Label Item Code: 3069 | The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua... | Class II | Cardinal Health 200, LLC |
| Oct 28, 2019 | Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062 | The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua... | Class II | Cardinal Health 200, LLC |
| Oct 22, 2019 | BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation | Following Customers complaints, investigations have been initiated on potentially false results o... | Class II | Biomerieux Inc |
| Oct 11, 2019 | Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions... | On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Mult... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 4, 2019 | Roche Homocysteine-In vitro test for the quantitative determination of total ... | Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 an... | Class II | Roche Diagnostics Operations, Inc. |
| Sep 23, 2019 | Atellica CH 930 Analyzer | Potential for calibration error resulting in QC failures after the calibration run with QC and pa... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 19, 2019 | Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-0904... | The firm has become aware there is a potential problem with its DABRA catheters resulting in high... | Class II | Ra Medical Systems, Inc. |
| Sep 11, 2019 | Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: I... | Due to low Quality Control recovery and invalid Calibration. | Class III | Roche Diagnostics Operations, Inc. |
| Sep 11, 2019 | Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - ... | Due to low Quality Control recovery and invalid Calibration. | Class III | Roche Diagnostics Operations, Inc. |
| Aug 9, 2019 | Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273... | The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1... | Class II | Randox Laboratories Ltd. |
| Aug 9, 2019 | Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05... | The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1... | Class II | Randox Laboratories Ltd. |
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.