Browse Device Recalls

688 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 688 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 688 FDA device recalls.

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DateProductReasonClassFirm
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.
Jul 5, 2016 Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software ... Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the ... Class III Siemens Healthcare Diagnostics Inc
Jun 22, 2016 Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument ... Software defect, where either an Above Assay Range or an inaccurate value could potentially be re... 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 11, 2016 Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 1044480... Premature bucket failures 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 24, 2016 Dimension Vista 1500 Intelligent Lab System running on software versions V.3.... Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confir... Class II Siemens Healthcare Diagnostics Inc.
Mar 24, 2016 Dimension Vista 500 Intelligent Lab System running on software versions V.3.6... Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confir... Class II 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
Nov 19, 2015 Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Num... Factor VIII Chromogenic Assay Lot 44637 is showing an increased occurrence of irregular curves wh... Class II Siemens Healthcare Diagnostics, Inc.
Nov 11, 2015 Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be use... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems 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.