Browse Device Recalls

700 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 700 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 700 FDA device recalls.

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DateProductReasonClassFirm
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
Apr 10, 2014 ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 103... 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, 500 test Catalog Number: 0649... 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 VitD 500 test, Ready Pack, Catalog Number: 10631021.... 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 VitD Total 100 test, Ready Pack, For OUS; SMN 1069920... Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, ... Class II Siemens Healthcare Diagnostics, Inc
Mar 25, 2014 Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat... Serum controls may go out of range low with the ADVIA Centaur ¿Systems Folate assay and a shift i... Class II Siemens Healthcare Diagnostics, Inc
Mar 19, 2014 Dimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro diagn... A complaint was received of Dimension Vista¿ CSA and CSAE under-recovery of cyclosporine when pat... Class II Siemens Healthcare Diagnostics, Inc.
Feb 18, 2014 ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyze... Instrument Cover Gas Spring failures. Over time, the gas spring may lose its effectiveness and f... Class II Siemens Healthcare Diagnostics
Jan 6, 2014 Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An... Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) a... Class II Siemens Healthcare Diagnostics, Inc.
Dec 20, 2013 IMMULITE 2000/2000 XPi Systems Androstenedione (Test Code AND), REF L2KAO2, S... Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater tha... Class II Siemens Healthcare Diagnostics
Dec 20, 2013 IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380... Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the... Class II Siemens Healthcare Diagnostics
Dec 20, 2013 IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SM... Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater tha... Class II Siemens Healthcare Diagnostics
Dec 20, 2013 IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD -... Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the... Class II Siemens Healthcare Diagnostics
Dec 18, 2013 ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 ... ADVIA Centaur¿ Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observe... Class II Siemens Healthcare Diagnostics, Inc
Dec 18, 2013 ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 ... ADVIA Centaur¿ Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observe... Class II Siemens Healthcare Diagnostics, Inc
Dec 17, 2013 Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical c... An overflow flag //// is displayed in the result column for a test when the algorithm for the tes... Class II Siemens Healthcare Diagnostics, Inc.
Dec 5, 2013 Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic... Complaints were received regarding variability in recovery of QC and patient results with certain... Class II Siemens Healthcare Diagnostics, Inc.
Nov 6, 2013 Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Us... The ADVIA Chemistry software systems using certain software versions allows the system to automat... Class II Siemens Healthcare Diagnostics, Inc.
Nov 6, 2013 IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 ... potential for an accelerated decline in counts per second (CPS) for three IMMULITE/IMMULITE 1000... Class II Siemens Healthcare Diagnostics
Oct 30, 2013 Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The... Under extremely rare circumstances, a patient result that had been previously disabled may be rel... Class II Siemens Healthcare Diagnostics, Inc.
Oct 7, 2013 User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension ... When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the syste... Class II Siemens Healthcare Diagnostics, Inc.
Sep 24, 2013 Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilir... Siemens Healthcare Diagnostics is conducting a field correction for Siemens Chemistry Calibrator ... Class II Siemens Healthcare Diagnostics
Sep 18, 2013 Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS metho... Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples. Class II Siemens Healthcare Diagnostics, Inc.
Sep 17, 2013 Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI ... Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shi... Class II Siemens Healthcare Diagnostics, Inc.
Sep 3, 2013 ADVIA 2400 System Software V4.01. Performs assays for general and specialt... Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters... Class II Siemens Healthcare Diagnostics
Sep 3, 2013 ADVIA 1800 System Software V2.01. Performs assays for general and specialt... Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters... Class II Siemens Healthcare Diagnostics
Sep 3, 2013 ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for genera... Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters... Class II Siemens Healthcare Diagnostics
Sep 3, 2013 ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for genera... Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters... Class II Siemens Healthcare Diagnostics
Aug 30, 2013 Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay Imprecision with certain lots Class II Siemens Healthcare Diagnostics, Inc.
Aug 27, 2013 T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material N... Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number ... Class II Siemens Healthcare Diagnostics
Aug 27, 2013 T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 1... Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number ... Class II Siemens Healthcare Diagnostics
Aug 21, 2013 Microscan rapID/S panels NC3.33 Sold in Japan only. Product Usage: Mi... Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... Class I Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013 Microscan plus Negative Combo 3 Sold outside of US only. Product Usage:... Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... Class I Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013 Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: Mi... Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... Class I Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013 Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan¿... Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... Class I Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013 Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan¿ Syne... Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... Class I Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013 Microscan plus Negative Urine Combo 4 Sold outside of US only. Product ... Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... Class I Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013 Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Pro... Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... Class I Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013 MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: Mic... Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... Class I 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.