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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Aug 21, 2013 | Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: Micro... | 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 2 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 Urine Combo 5 Product Usage: MicroSca... | Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... | Class I | Siemens Healthcare Diagnostics, Inc. |
| Aug 16, 2013 | ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 ... | PTH Calibrator packaged with only high calibrator. | Class III | Siemens Healthcare Diagnostics, Inc |
| Aug 13, 2013 | Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) ... | May not perform as intended under certain conditions, causing the release of results to the Labor... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 12, 2013 | ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN... | Siemens determined that if an autosampler rack jam error occurs during operation of an ADVIA 2120... | Class II | Siemens Healthcare Diagnostics |
| Jul 30, 2013 | ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/US... | Siemens confirmed that the ADVIA¿ Chemistry Systems HbA1c method exhibits a positive bias of up t... | Class II | Siemens Healthcare Diagnostics |
| Jul 25, 2013 | ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro... | Calibration failures and/or significant negative shifts in quality control (QC) and patient results. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 25, 2013 | ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vi... | Calibration failures and/or significant negative shifts in quality control (QC) and patient results. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 25, 2013 | ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro d... | Calibration failures and/or significant negative shifts in quality control (QC) and patient results. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 25, 2013 | ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In v... | Calibration failures and/or significant negative shifts in quality control (QC) and patient results. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 1, 2013 | Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (D... | Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimens... | 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.