Browse Device Recalls

571 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 571 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 571 FDA device recalls.

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DateProductReasonClassFirm
Aug 30, 2016 IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number ... Multiple customers reported seeing an increase in imprecision with some patients resulting in hig... Class II Siemens Healthcare Diagnostics, Inc.
Aug 30, 2016 IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D... Multiple customers reported seeing an increase in imprecision with some patients resulting in hig... Class II Siemens Healthcare Diagnostics, Inc.
Aug 25, 2016 Dimension IRON Flex reagent cartridges Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and D... Class III Siemens Healthcare Diagnostics, Inc.
Aug 25, 2016 Dimension Vista IRON Flex reagent cartridges Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and D... Class III Siemens Healthcare Diagnostics, Inc.
Aug 24, 2016 SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number ... Siemens received multiple customer complaints indicating an increase in false positive and indete... Class II Siemens Healthcare Diagnostics, Inc.
Aug 24, 2016 SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number ... Siemens received multiple customer complaints indicating an increase in false positive and indete... Class II Siemens Healthcare Diagnostics, Inc.
Aug 9, 2016 ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/S... Communication provided to emphasize that the PSA values should be interpreted in accordance with ... Class II Siemens Healthcare Diagnostics, Inc
Aug 8, 2016 Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrat... Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from... Class II Siemens Healthcare Diagnostics, Inc
Aug 3, 2016 Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D... Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cart... Class II Siemens Healthcare Diagnostics, Inc.
Jul 20, 2016 ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA... Siemens identified an issue with the ratio equation provided on the ADVIA Chemistry XPT System So... Class II Siemens Healthcare Diagnostics, Inc.
Jun 17, 2016 Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogene... Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, wh... Class II Siemens Healthcare Diagnostics, Inc.
Jun 17, 2016 ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vit... Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, wh... Class II Siemens Healthcare Diagnostics, Inc.
May 26, 2016 ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 108197... Eight (8) issues were identified which may affect the results generated by the system software ve... Class II Siemens Healthcare Diagnostics, Inc.
May 5, 2016 The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration... Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the... Class III Siemens Healthcare Diagnostics, Inc.
May 5, 2016 The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Am... Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the... Class III Siemens Healthcare Diagnostics, Inc.
May 2, 2016 Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for qu... Exhibits a greater than 10% change in results in samples with biotin levels up to 10 ng/mL (41 nm... Class II Siemens Healthcare Diagnostics, Inc
Apr 28, 2016 ADVIA Centaur XPT Immunoassay System The ADVIA Centaur¿ XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) ... Class II Siemens Healthcare Diagnostics, Inc.
Apr 15, 2016 IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insu... 24 minutes of incubation is required prior to processing patient samples and for the pretreatment... Class II Siemens Healthcare Diagnostics, Inc.
Mar 30, 2016 ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710,... The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two ina... Class III Siemens Healthcare Diagnostics, Inc.
Mar 17, 2016 ADVIA CHEMISTRY ENZYMATIC CREATININE_2 Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... Class II Siemens Healthcare Diagnostics, Inc.
Mar 17, 2016 Advia Chemistry Assay: LDL Cholesterol, Direct Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... Class II Siemens Healthcare Diagnostics, Inc.
Mar 17, 2016 Dimension Assays: Uric Acid (URCA) Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... Class II Siemens Healthcare Diagnostics, Inc.
Mar 17, 2016 Advia Chemistry Assay: Lactate Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... Class II Siemens Healthcare Diagnostics, Inc.
Mar 17, 2016 Dimension Vista Assays: Enzymatic Creatine (ECRE) Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... Class II Siemens Healthcare Diagnostics, Inc.
Mar 17, 2016 Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Chol... Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... Class II Siemens Healthcare Diagnostics, Inc.
Mar 17, 2016 Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... Class II Siemens Healthcare Diagnostics, Inc.
Mar 17, 2016 Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL) Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... Class II Siemens Healthcare Diagnostics, Inc.
Mar 17, 2016 Dimension Vista Assays: Uric Acid (URCA) Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... Class II Siemens Healthcare Diagnostics, Inc.
Mar 17, 2016 Dimension Vista Assays: Direct HDL Cholesterol (AHDL) Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... Class II Siemens Healthcare Diagnostics, Inc.
Mar 17, 2016 ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERI... Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... Class II Siemens Healthcare Diagnostics, Inc.
Mar 17, 2016 Dimension Vista Assays: Triglycerides (TRIG) Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... Class II Siemens Healthcare Diagnostics, Inc.
Mar 17, 2016 Dimension Assays: Direct HDL Cholesterol (AHDL) Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... Class II Siemens Healthcare Diagnostics, Inc.
Mar 17, 2016 Dimension Assays: ENZYMATIC CREATININE Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... Class II Siemens Healthcare Diagnostics, Inc.
Mar 17, 2016 ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentra... Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... Class II Siemens Healthcare Diagnostics, Inc.
Mar 17, 2016 Dimension Assays: Triglycerides (TGL) Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... Class II Siemens Healthcare Diagnostics, Inc.
Mar 10, 2016 ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD ... Software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology S... Class II Siemens Healthcare Diagnostics, Inc.
Mar 8, 2016 Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended fo... Siemens Healthcare Diagnostics confirmed that Syva Emit Methotrexate Application (DVMTX.1) for Di... Class II Siemens Healthcare Diagnostics, Inc.
Mar 7, 2016 ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 1069757... Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagen... Class II Siemens Healthcare Diagnostics, Inc.
Feb 16, 2016 Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN m... Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots... Class II Siemens Healthcare Diagnostics, Inc.
Feb 9, 2016 Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge ... Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecisi... Class II Siemens Healthcare Diagnostics, Inc.
Feb 4, 2016 Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference)... ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay Class II Siemens Healthcare Diagnostics, Inc
Feb 4, 2016 Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog... ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay Class II Siemens Healthcare Diagnostics, Inc
Feb 4, 2016 Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Nu... ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay Class II Siemens Healthcare Diagnostics, Inc
Jan 14, 2016 BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in v... False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also a... Class II Siemens Healthcare Diagnostics, Inc.
Jan 14, 2016 BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for i... False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also a... Class II Siemens Healthcare Diagnostics, Inc.
Jan 13, 2016 Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 104... The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results. Class II Siemens Healthcare Diagnostics, Inc
Jan 13, 2016 IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25... The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results. Class II Siemens Healthcare Diagnostics, Inc
Jan 13, 2016 Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490... The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results. Class II Siemens Healthcare Diagnostics, Inc
Jan 13, 2016 IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE... The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results. Class II Siemens Healthcare Diagnostics, Inc
Dec 29, 2015 ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit)... PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU). Class II Siemens Healthcare 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.