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.

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DateProductReasonClassFirm
Aug 29, 2025 Getinge 88-Series Washer- Disinfector. Model Number: 88-5. Potential for device to overheat during operation if the circulation pressure calibration was not... Class II Getinge Disinfection Ab
Aug 11, 2025 Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 1109... Potential for falsely depressed patient, quality control (QC), and/or calibration results or dela... Class II Siemens Healthcare Diagnostics, Inc.
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.
May 28, 2025 CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Ca... Due to an error in assembly of the thermistor within some units, the affected probes will experie... Class II Terumo Cardiovascular Systems Corporation
May 8, 2025 GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will g... Class II Ohio Medical Corporation
May 7, 2025 DxI 9000 Access Immunoassay Analyzer C11137 Analyzer has calibration issues where curves switched from passed to failed due to system errors ... Class II Beckman Coulter, Inc.
Apr 23, 2025 Apo B Reagent, REF: OSR6143 The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value... Class III Beckman Coulter Ireland, Inc.
Mar 20, 2025 DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / ... Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software erro... Class II Beckman Coulter Inc.
Feb 20, 2025 IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: ... IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and n... Class II Omnicell, Inc.
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning Sys... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 2, 2025 Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and Uni... Identified reagent lots are experiencing a high rate of calibration failures with failure code of... Class II Beckman Coulter 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.
Oct 7, 2024 DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361 The user of the assay may either face a failure message during re-calibration of the Hybrid.XL in... Class II DRG International, Inc.
Sep 30, 2024 The Access Cortisol assay is a paramagnetic particle, chemiluminescent immun... The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance p... Class II Beckman Coulter, Inc.
Aug 26, 2024 FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the F... Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect in... Class II Qualigen 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.
Jun 5, 2024 DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemist... There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved f... Class II Beckman Coulter Mishima K.K.
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
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.
Apr 18, 2024 Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitr... When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is co... Class II Beckman Coulter, Inc.
Apr 18, 2024 DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic ... Class II Beckman Coulter, Inc.
Mar 11, 2024 OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the met... System error messages may delay the ability to test patient samples and the need for frequent cal... Class II Advanced Instruments, LLC
Mar 9, 2024 Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Gal... Due to a misaligned calibration of the wired controller that may result in unintended motion of t... Class II Noah Medical
Mar 5, 2024 Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml ... Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351... Class II Randox Laboratories Ltd.
Feb 23, 2024 The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a uniq... Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for l... Class II Magellan Diagnostics, Inc.
Feb 21, 2024 ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. The reason for the recall is the failure of calibration and quality controls due to a manufacturi... Class II Abbott Laboratories
Feb 15, 2024 Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower ... Class II Bio-Rad Laboratories
Feb 14, 2024 Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of t... Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods Class II Randox Laboratories Ltd.
Dec 7, 2023 ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGP... Class I Globus Medical, 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.
Nov 20, 2023 Calibration Serum Level 3 CAL2351 CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series inst... Class II Randox Laboratories Ltd.
Nov 20, 2023 Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry... Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-ass... Class II Randox Laboratories Ltd.
Nov 13, 2023 Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level... There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum ... Class II Randox Laboratories Ltd.
Sep 6, 2023 AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solu... The firm has identified that the Transferrin reagent does not meet the Instructions for Use (IFU)... Class II Beckman Coulter Biomedical Division
Aug 16, 2023 Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... Class II Smiths Medical ASD Inc.
Aug 16, 2023 Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on... A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... Class II Smiths Medical ASD Inc.
Aug 16, 2023 Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6 A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... Class II Smiths Medical ASD 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.