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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 29, 2017 | Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444... | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2017 | ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended t... | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2017 | Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens ... | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2017 | Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: ... | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2017 | ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended t... | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 7, 2017 | ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Materia... | Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol... | Class II | Siemens Healthcare Diagnostics, Inc |
| May 23, 2017 | Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN... | Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 23, 2017 | Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SM... | Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 23, 2017 | Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (S... | Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 23, 2017 | Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (S... | Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 5, 2017 | ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog ... | Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than... | Class II | Siemens Healthcare Diagnostics, Inc |
| Apr 5, 2017 | ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 0223... | Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than... | Class II | Siemens Healthcare Diagnostics, Inc |
| Mar 21, 2017 | Dimension Troponin 1 (TNI) Flex reagent cartridge | The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dim... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 21, 2017 | Dimension Vista Ferritin (FERR) Flex reagent cartridge | The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dim... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 21, 2017 | Dimension Vista Estradiol (E2) Flex reagent cartridge | The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dim... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 21, 2017 | Dimension Vista Digoxin (DIGXN) Flex reagent cartridge | The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dim... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 21, 2017 | Dimension Vista Prolactin (PRL) Flex reagent cartridge | The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dim... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 21, 2017 | Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge | The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dim... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 8, 2017 | Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 te... | Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the... | Class II | Siemens Healthcare Diagnostics, Inc |
| Mar 8, 2017 | Siemens ADVIA Centaur BR assay Cat No. 02419937, SMN 10333349 (1-pack/50 tes... | Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the... | Class II | Siemens Healthcare Diagnostics, Inc |
| Mar 8, 2017 | Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 te... | Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the... | Class II | Siemens Healthcare Diagnostics, Inc |
| Mar 3, 2017 | Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intellige... | Siemens Healthcare Diagnostics has confirmed that in isolated cases when ECREA is processed immed... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 23, 2017 | ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: ... | Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and ... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Feb 2, 2017 | ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V... | Multiple software issues, which may affect the operation and workflow of the system. Potential fo... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 31, 2017 | SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with th... | Certain lots of Sex Hormone Binding Globulin (SHBG) do not meet the thirty (30) day open vial adj... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 11, 2017 | N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usag... | The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OP... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 10, 2017 | Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 1028... | Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with... | Class II | Siemens Healthcare Diagnostics, Inc |
| Jan 10, 2017 | Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 1028... | Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with... | Class II | Siemens Healthcare Diagnostics, Inc |
| Jan 10, 2017 | Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 1028... | Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with... | Class II | Siemens Healthcare Diagnostics, Inc |
| Jan 4, 2017 | ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Pro... | DHEA-S causes falsely elevated progesterone results. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jan 4, 2017 | Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Nu... | DHEA-S causes falsely elevated progesterone results. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jan 4, 2017 | IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material... | DHEA-S causes falsely elevated progesterone results. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jan 4, 2017 | IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material... | DHEA-S causes falsely elevated progesterone results. | Class II | Siemens Healthcare Diagnostics, Inc |
| Dec 21, 2016 | IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP... | Negative bias with IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific antigen) kit... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 21, 2016 | IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3P... | Negative bias results with the IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 16, 2016 | Dimension Vista¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM me... | Siemens Healthcare Diagnostics has determined that Dimension Vista AMM (K3119) Flex reagent cartr... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 16, 2016 | Dimension¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method ... | Siemens Healthcare Diagnostics has determined that Dimension AMM (DF119) flex reagent cartridge l... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 29, 2016 | CentraLink¿ Data Management System Software Versions: v13x,v14x,v15x The C... | There is a remote possibility CentraLink may download an order to the ADVIA Automation System wit... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2016 | SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) T... | Siemens is conducting this recall for the IMMULITE¿ 2000/IMMULITE¿ 2000 XPi Intact PTH (Intact Pa... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 18, 2016 | IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay... | Siemens Healthcare Diagnostics confirmed that the IMMULITE 2000/ IMMULITE 2000 XPi Systems PSA a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 18, 2016 | IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Cat... | Siemens Healthcare Diagnostics has confirmed that the IMMULITE/ IMMULITE 1000 Systems PSA assays ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 21, 2016 | ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD. | Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens rec... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 19, 2016 | ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur an... | CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the A... | Class II | Siemens Healthcare Diagnostics, Inc |
| Oct 19, 2016 | ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur an... | CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the A... | Class II | Siemens Healthcare Diagnostics, Inc |
| Oct 7, 2016 | Advia Chemistry Calibrator For in vitro diagnostic use in the calibration o... | Siemens has confirmed that the DBIL_2 Assigned Calibrator Values (ACV) currently assigned to the ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 5, 2016 | Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test) | Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias wit... | Class II | Siemens Healthcare Diagnostics, Inc |
| Oct 5, 2016 | Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test) | Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias wit... | Class II | Siemens Healthcare Diagnostics, Inc |
| Sep 29, 2016 | FlexLab Automation Modules | Class II | Siemens Healthcare Diagnostics, Inc. | |
| Sep 29, 2016 | Aptio Automation Modules | Possible overheating of power cord plugs used to connect to FlexLab and Aptio Automation systems. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 15, 2016 | Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) i... | Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with ... | 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.