Browse Device Recalls
463 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 463 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 463 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 2, 2018 | IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi 3g Allergy specific IgE Universal Kit | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | IMMULITE ¿ /IMMULITE ¿ 1000 Vitamin B12 | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | ADVIA Centaur¿ Cyclosporine | The concentrations for biotin listed in the non-interfering substances section of the instruction... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge | The concentrations for biotin listed in the non-interfering substances section of the instruction... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | IMMULITE ¿ /IMMULITE ¿ 1000 CEA | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | ADVIA Centaur¿ HBc IgM | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge | The concentrations for biotin listed in the non-interfering substances section of the instruction... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | ADVIA Centaur¿ DHEA-SO4 | The concentrations for biotin listed in the non-interfering substances section of the instruction... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125) | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3) | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3) | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 18, 2017 | ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (10... | In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced d... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 18, 2017 | ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbe... | In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced d... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 14, 2017 | Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, pho... | Calibration failure - confirmed a positive bias with LIPL lot FB8109 when compared to other Dimen... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 27, 2017 | Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophy... | Lot J1 of the Syva¿ EMIT¿ 2000 Theophylline Assay, when run on a Beckman AU Clinical Chemistry S... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 9, 2017 | Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in v... | An increase in the number of failed calibration events or negative bias with Quality Control (QC)... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2017 | Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Si... | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2017 | Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475... | 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 Alanine Aminotransferase (ALTI) assay; (Product Number: K2143... | 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 Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: S... | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2017 | Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr... | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2017 | Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siem... | 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 Aspartate Aminotransferase (AST) assay; (Product Number: K201... | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2017 | Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Sieme... | 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 Creatine Kinase MB (MBI) assay; (Product Number: K3032/104643... | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2017 | Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (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 Glucose (GLUC) assay (Product Number: DF40/10444973) (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 | ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative dete... | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| 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. |
| 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. |
| 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. |
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.