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
Dec 30, 2014 RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 103223... Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration ... Class II Siemens Healthcare Diagnostics Inc
Dec 30, 2014 RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179.... Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration ... Class II Siemens Healthcare Diagnostics Inc
Dec 30, 2014 RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524.... Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration ... Class II Siemens Healthcare Diagnostics Inc
Dec 30, 2014 RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number: 10492730, 106968... Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration ... Class II Siemens Healthcare Diagnostics Inc
Dec 16, 2014 ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x... Enabling sending of preliminary/initial results on the ADVIA Chemistry XPT creates a risk that a ... Class II Siemens Healthcare Diagnostics, Inc.
Nov 24, 2014 Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage:... Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient... Class II Siemens Healthcare Diagnostics, Inc.
Nov 5, 2014 Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligen... Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Reagent probe... Class II Siemens Healthcare Diagnostics, Inc.
Oct 27, 2014 Turbo Troponin I For in vitro diagnostic use for the quantitative measurem... Class II Siemens Healthcare Diagnostics, Inc.
Oct 20, 2014 IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, I... A typographical error regarding the expiration date was identified in the control module instruct... Class III Siemens Healthcare Diagnostics, Inc.
Oct 17, 2014 Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapi... An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Ne... Class I Siemens Healthcare Diagnostics, Inc.
Oct 17, 2014 Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Mater... An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Ne... Class I Siemens Healthcare Diagnostics, Inc.
Oct 9, 2014 ADVIA Centaur XP Immunoassay System (including refurbished) Professional u... A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may oc... Class II Siemens Healthcare Diagnostics, Inc.
Oct 9, 2014 ADVIA Centaur (including refurbished) Professional use in a laboratory for... A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may oc... Class II Siemens Healthcare Diagnostics, Inc.
Oct 6, 2014 ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative deter... Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Ce... Class III Siemens Healthcare Diagnostics, Inc
Sep 30, 2014 Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C... Certain lots of the reagent cartridges show confirmed positive bias averaging 0.4% Hemoglobin A1c... Class II Siemens Healthcare Diagnostics, Inc.
Sep 26, 2014 Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335... Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortis... Class II Siemens Healthcare Diagnostics, Inc
Sep 24, 2014 siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used o... Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with... Class II Siemens Healthcare Diagnostics, Inc.
Sep 19, 2014 External power supply adaptors that accompany Clinitek Status Power Supply Ad... The external power supply for the Clintek Status analyzer, which is provided separately, is damag... Class II Siemens Healthcare Diagnostics, Inc
Sep 19, 2014 IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 1... Customer complaints were received for positive bias reported on the controls used on the IMMULITE... Class II Siemens Healthcare Diagnostics
Sep 19, 2014 External power supply adaptors that accompany Clinitek Status Connect System ... The external power supply for the Clintek Status analyzer, which is provided separately, is damag... Class II Siemens Healthcare Diagnostics, Inc
Sep 19, 2014 External power supply adaptors that accompany Clinitek Status+ The Clinite... The external power supply for the Clintek Status analyzer, which is provided separately, is damag... Class II Siemens Healthcare Diagnostics, Inc
Sep 15, 2014 ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. C... Increased imprecision and positive bias is observed with patient samples and negative controls an... Class II Siemens Healthcare Diagnostics, Inc
Sep 15, 2014 Siemens ADVIA Centaur¿ Systems HBc Total (HBcT), Reagent. For In Vitro Diagno... Increased imprecision and positive bias is observed with patient samples and negative controls an... Class II Siemens Healthcare Diagnostics, Inc
Sep 12, 2014 ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution ... Stability of the ADVIA Centaur Cleaning Solution is not assured Class III Siemens Healthcare Diagnostics, Inc
Aug 28, 2014 Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnos... Siemens Healthcare Diagnostics has determined that Dimension Vista® Mass CKMB Isoenzyme Calib... Class II Siemens Healthcare Diagnostics, Inc.
Aug 19, 2014 Siemens CentraLink Data Management System, software version 14. The Cent... Siemens Healthcare Diagnostics has identified a task scheduler issue with the CentraLink" Da... Class II Siemens Healthcare Diagnostics, Inc.
Aug 19, 2014 ADVIA Centaur Immunoassay System (including refurbished units), This syst... The firm has identified an issue with patient demographic information sent to the LIS from the AD... Class II Siemens Healthcare Diagnostics
Aug 19, 2014 ADVIA Centaur XP Immunoassay System (including refurbished units), This s... The firm has identified an issue with patient demographic information sent to the LIS from the AD... Class II Siemens Healthcare Diagnostics
Aug 18, 2014 Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in v... Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2014 Dimension Vista¿ HbA1c In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased... Class II Siemens Healthcare Diagnostics, Inc.
Aug 13, 2014 ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (S... The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay ... Class II Siemens Healthcare Diagnostics
Aug 13, 2014 ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers... The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay ... Class II Siemens Healthcare Diagnostics
Aug 6, 2014 ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems... The ADVIA Chemistry Systems A1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin... Class II Siemens Healthcare Diagnostics
Jul 16, 2014 Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices... The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance pro... Class II Siemens Healthcare Diagnostics, Inc.
Jul 15, 2014 Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridg... Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) o... Class II Siemens Healthcare Diagnostics, Inc.
Jun 23, 2014 SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test ... Complaints of failed calibration. Class II Siemens Healthcare Diagnostics, Inc
Jun 23, 2014 SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test ... Complaints of failed calibration. Class II Siemens Healthcare Diagnostics, Inc
Jun 9, 2014 Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Sie... The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to altern... Class II Siemens Healthcare Diagnostics Inc.
Jun 2, 2014 Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centa... Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles Class II Siemens Healthcare Diagnostics, Inc
Jun 2, 2014 MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrume... Springs contained in the access door hinge assembly on the Walk Away Plus instruments are becomin... Class II Siemens Healthcare Diagnostics, Inc.
May 30, 2014 ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), ... The solid phase reagent in some of the ADVIA Centaur¿ TnI -Ultra ReadyPacks¿, lot 084, is darker ... Class II Siemens Healthcare Diagnostics, Inc
May 27, 2014 Dimension¿ Integrated Chemistry Systems intended to measure a variety of anal... There is a misassembly issue with the photometer installed on Dimension¿ Integrated Chemistry Sy... Class III Siemens Healthcare Diagnostics, Inc.
May 23, 2014 RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurem... RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters ... Class II Siemens Healthcare Diagnostics Inc
May 22, 2014 Siemens RAPIDComm¿ Data Management System. The RAPIDComm¿ Data Management ... RAPIDComm¿ 5.0 Screen Layout will display incorrect test names Class III Siemens Healthcare Diagnostics Inc
May 20, 2014 syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573. Certain configuration parameters may cause the reference ranges to not hold results as expected a... Class II Siemens Healthcare Diagnostics, Inc.
May 14, 2014 MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Pan... Siemens Healthcare Diagnostics has received complaints regarding panel degradation with a portion... Class II Beckman Coulter, Inc.
Apr 14, 2014 Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor ... A small number of Vista Air Compressors were miswired, which if installed and powered up, could c... Class II Siemens Healthcare Diagnostics, Inc.
Apr 10, 2014 ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994. ... Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, ... Class II Siemens Healthcare Diagnostics, Inc
Apr 10, 2014 ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemen... Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, ... Class II Siemens Healthcare Diagnostics, Inc
Apr 10, 2014 ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491... Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, ... 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.