Browse Device Recalls
84 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 84 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 84 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 29, 2025 | Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contai... | VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencin... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jul 29, 2025 | VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit =... | VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencin... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jul 9, 2025 | VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261; | Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Conditio... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jun 12, 2025 | VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITR... | Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than exp... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jun 10, 2025 | VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 ... | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jun 10, 2025 | VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 sli... | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jun 10, 2025 | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jun 10, 2025 | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain... | Class II | Ortho-Clinical Diagnostics, Inc. |
| May 9, 2025 | Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalo... | A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent pa... | Class II | Ortho-Clinical Diagnostics, Inc. |
| May 9, 2025 | Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog... | a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent pa... | Class II | Ortho-Clinical Diagnostics, Inc. |
| May 9, 2025 | Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/C... | a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent pa... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Apr 14, 2025 | VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, o... | Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and ca... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Mar 24, 2025 | Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetell... | It was determined that there could be a false positive rate of up to 16.7% for the affected lots ... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Dec 19, 2024 | Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/... | The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if... | Class II | Ortho-Clinical Diagnostics, INc. |
| Dec 19, 2024 | Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalo... | The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the S... | Class II | Ortho-Clinical Diagnostics, INc. |
| Dec 19, 2024 | Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Cat... | The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if th... | Class II | Ortho-Clinical Diagnostics, INc. |
| Oct 11, 2024 | VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively meas... | May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, show... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jul 10, 2024 | The VITROS XT Chemistry Products ALB-TP Slides is a single device that contai... | The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jul 3, 2024 | VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 | It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the ... | Class II | Ortho-Clinical Diagnostics, Inc. |
| May 21, 2024 | VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. ... | VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biase... | Class II | Ortho-Clinical Diagnostics, Inc. |
| May 14, 2024 | VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the V... | Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration da... | Class III | Ortho-Clinical Diagnostics, Inc. |
| May 8, 2024 | VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagno... | The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 120... | Class III | Ortho-Clinical Diagnostics, Inc. |
| Mar 1, 2024 | VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Ca... | Potential for positively biased results due to signal reduction over shelf life. | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS XT 3400 Chemistry System, Catalog No. 6844458 | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 680291... | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refu... | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (ref... | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refu... | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 680291... | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS XT 7600 Integrated System, Catalog No. 6844461 | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS XT 3400 Chemistry System, Catalog No. 6844458 | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS XT 7600 Integrated System, Catalog No. 6844461 | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (ref... | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 22, 2024 | VITROS 3600 Immunodiagnostic System (New and Refurbished) | Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VI... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 22, 2024 | VITROS XT7600 Integrated System | Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VI... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 22, 2024 | VITROS 5600 Integrated System (New and Refurbished) | Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VI... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Nov 27, 2023 | VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog ... | Affected lots may experience increased calibration failures or an increase in falsely elevated re... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Nov 21, 2023 | QMS Tacrolimus Calibrators, Product code 10015573 | Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry dat... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Oct 25, 2023 | VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITR... | Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coa... | Class II | Ortho-Clinical Diagnostics, INc. |
| Oct 10, 2023 | VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Prod... | During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Oct 10, 2023 | VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Co... | During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Oct 10, 2023 | VITROS XT 7600 Integrated System Product Code 6844461 Running Software Versio... | During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Oct 10, 2023 | VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Cod... | During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Oct 10, 2023 | VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version... | During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Sep 12, 2023 | VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 S... | Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cau... | Class II | Ortho-Clinical Diagnostics, INc. |
| Aug 9, 2023 | Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry Sy... | Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactur... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Aug 5, 2023 | VITROS XT Chemistry Products TBIL-ALKP Slides | Samples containing high levels of ALKP (or an interfering substance) could deplete the available ... | Class II | Ortho-Clinical Diagnostics, INc. |
| Aug 5, 2023 | VITROS XT Chemistry Products ALKP Slides | Samples containing high levels of ALKP (or an interfering substance) could deplete the available ... | Class II | Ortho-Clinical Diagnostics, INc. |
| May 18, 2023 | VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro di... | May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU). | Class III | Ortho-Clinical Diagnostics, Inc. |
| Apr 17, 2023 | VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determi... | Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis | Class II | Ortho-Clinical Diagnostics, 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.