Browse Device Recalls
127 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 127 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 127 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 20, 2026 | cobas pro integrated solutions with cobas c 503 analytical units: cobas pr... | Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spl... | Class II | Roche Diagnostics Operations, Inc. |
| Nov 21, 2025 | The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay wit... | Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. ... | Class II | Roche Diagnostics Operations, Inc. |
| Oct 17, 2024 | cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, fo... | Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Ass... | Class II | Roche Diagnostics Operations, Inc. |
| Aug 15, 2024 | Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-I... | Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 40... | Class II | Roche Diagnostics Operations, Inc. |
| Oct 3, 2023 | Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay,... | Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma sa... | Class II | Roche Diagnostics Operations, Inc. |
| Dec 12, 2022 | cobas infinity central lab, Material Number 07154003001 | A complaint investigation revealed that an incorrect behavior relating to the rejection of orders... | Class II | Roche Diagnostics Operations, Inc. |
| Jul 14, 2022 | cobas e801 Immunoassay Analyzer | Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The... | Class II | Roche Diagnostics Operations, Inc. |
| Oct 18, 2021 | Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 6... | A potential risk for false negative nitrite results exists when endogenous creatinine levels are ... | Class II | Roche Diagnostics Operations, Inc. |
| Jun 24, 2021 | cobas infinity central lab running software version 3.01.03 through 3.02.08, ... | Under specific circumstances created by the user, the cobas e flow test results could be replaced... | Class II | Roche Diagnostics Operations, Inc. |
| Apr 26, 2021 | IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 031836... | Roche received several complaints regarding increased control recovery and discrepant elevated re... | Class II | Roche Diagnostics Operations, Inc. |
| Apr 7, 2021 | Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intende... | Recall reason is possible sporadic false negative conventional troponin results. Roche has confir... | Class II | Roche Diagnostics Operations, Inc. |
| Apr 7, 2021 | Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: in... | Recall reason is possible sporadic false negative conventional troponin results. Roche has confir... | Class II | Roche Diagnostics Operations, Inc. |
| Jan 6, 2021 | 9180 Electrolyte Analyzer - Product Usage: intended to be used for the measur... | May display Calcium results on the screen with wrong arrow direction which may lead to misinterpr... | Class II | Roche Diagnostics Operations, Inc. |
| Dec 17, 2020 | A calculator/data processing module for clinical use is an electronic device ... | A software error results in the unintentional removal of the serum-indices flag that would otherw... | Class II | Roche Diagnostics Operations, Inc. |
| Dec 8, 2020 | Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas ... | Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro ... | Class II | Roche Diagnostics Operations, Inc. |
| Dec 8, 2020 | Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e... | Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro ... | Class II | Roche Diagnostics Operations, Inc. |
| Dec 2, 2020 | CoaguChek XS Prof (Professional) Meters- IVD professional healthcare provider... | Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing ... | Class II | Roche Diagnostics Operations, Inc. |
| Dec 2, 2020 | CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting t... | Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing ... | Class II | Roche Diagnostics Operations, Inc. |
| Nov 23, 2020 | cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric... | During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically ... | Class II | Roche Diagnostics Operations, 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. |
| Oct 9, 2020 | cobas infinity central lab/cobas infinity core license-The cobas infinity IT ... | Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expira... | Class II | Roche Diagnostics Operations, Inc. |
| Aug 31, 2020 | BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001 | Potential for Fluid leaks within the instruments, creating an electrical short inside the power s... | Class II | Roche Diagnostics Operations, Inc. |
| Aug 31, 2020 | DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Nu... | Potential for Fluid leaks within the instruments, creating an electrical short inside the power s... | 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 20, 2020 | Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 063... | Recent internal verification studies found the current RF interference claim to no longer be met ... | Class II | Roche Diagnostics Operations, Inc. |
| Feb 7, 2020 | Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immu... | The firm has received an increased number of complaints concerning non-reproducible elevated resu... | Class II | Roche Diagnostics Operations, Inc. |
| Jan 7, 2020 | cobas infinity core, Material No. 7154003001. The device is a calculator/data... | Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Valid... | Class II | Roche Diagnostics Operations, Inc. |
| Oct 28, 2019 | Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM anti... | Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneo... | Class II | Roche Diagnostics Operations, Inc. |
| Oct 8, 2019 | Cobas infinity central lab / cobas infinity core license-a Calculator/Data Pr... | Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver -... | Class II | Roche Diagnostics Operations, 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 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 28, 2019 | cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF i... | Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Int... | Class II | Roche Diagnostics Operations, Inc. |
| Aug 28, 2019 | cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay... | Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Int... | Class II | Roche Diagnostics Operations, Inc. |
| Aug 13, 2019 | AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the ... | AssayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 module- may have an A... | Class II | Roche Diagnostics Operations, Inc. |
| Jul 23, 2019 | Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Mod... | Inaccurately Low Sample Results | Class II | Roche Diagnostics Operations, Inc. |
| Jul 23, 2019 | Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Modu... | Inaccurately Low Sample Results | Class II | Roche Diagnostics Operations, Inc. |
| Jul 18, 2019 | Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 0... | Quality issue with high pressure solenoid valves | Class II | Roche Diagnostics Operations, Inc. |
| Jul 18, 2019 | cobas c513 Analyzer | Quality issue with high pressure solenoid valves | Class II | Roche Diagnostics Operations, Inc. |
| Jul 18, 2019 | cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001 | Quality issue with high pressure solenoid valves may cause inaccurate results. | Class II | Roche Diagnostics Operations, Inc. |
| Jul 16, 2019 | Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190 | Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; M... | Class II | Roche Diagnostics Operations, Inc. |
| Jul 16, 2019 | Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160 | Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; M... | Class II | Roche Diagnostics Operations, Inc. |
| Jul 2, 2019 | The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay... | The firm conducted internal investigations that confirmed customer complaints of quality control ... | Class II | Roche Diagnostics Operations, Inc. |
| Oct 31, 2016 | MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: coba... | Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and ca... | Class II | Roche Diagnostics Operations, Inc. |
| Oct 4, 2016 | Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 0452812... | Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quan... | Class II | Roche Diagnostics Operations, Inc. |
| Oct 4, 2016 | COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Ca... | .Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-qua... | Class II | Roche Diagnostics Operations, Inc. |
| Sep 27, 2016 | Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for cl... | cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to... | Class II | Roche Diagnostics Operations, Inc. |
| Jul 15, 2016 | cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: Th... | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... | Class II | Roche Diagnostics Operations, Inc. |
| Jul 15, 2016 | cobas p 312 Pre-Analytical System calculator/data processing module, for cli... | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... | Class II | Roche Diagnostics Operations, 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.