Browse Device Recalls
454 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 454 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 454 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Aug 30, 2013 | Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay | Imprecision with certain lots | Class II | Siemens Healthcare Diagnostics, Inc. |
| 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 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. |
| 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 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. |
| Jun 19, 2013 | Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Disp... | Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 5, 2013 | Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass C... | Siemens Healthcare Diagnostics has received complaints that the lyophilized cake is not fully dis... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 20, 2013 | Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - l... | There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample dil... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 10, 2013 | syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely conso... | Under certain conditions the system may not perform as intended, causing the release of results t... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 6, 2013 | Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 ... | Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sampl... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 2, 2013 | Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417)... | The product has the potential for false negative or delayed reaction for Arginine (ARG) results. ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 25, 2013 | Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an ... | Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may r... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 22, 2013 | HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for... | Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above A... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 22, 2013 | HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) fo... | Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above A... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 11, 2013 | Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination o... | Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 6, 2013 | Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-20... | Customer complaint investigation confirmed the issue of false skipped wells and false susceptible... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 27, 2013 | Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intend... | Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an inc... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Feb 27, 2013 | Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Inten... | Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an inc... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Feb 27, 2013 | Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). I... | Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an inc... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Feb 22, 2013 | Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) Th... | Siemens Healthcare Diagnostics has initiated a voluntary field action for Dimension(R) PHOS Flex(... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 21, 2013 | Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used... | Siemens has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 20, 2012 | Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The... | Siemens Healthcare Diagnostics has received complaints of IRON calibrations outside of acceptable... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Dec 20, 2012 | Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in... | The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no ... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Dec 19, 2012 | Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reage... | Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista Urinary/C... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 10, 2012 | Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital... | Firm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 6, 2012 | Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit... | Incorrect expiration date was assigned to the D1 lot of Emit(R) tox(TM) Serum Calibrators. The c... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Nov 27, 2012 | Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR m... | Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR F... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 11, 2012 | Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Desig... | Firm has received reports from customers that the small pins at the bottom of the center door pan... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 10, 2012 | Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP C... | Correlation slope bias and accuracy shift | Class III | Siemens Healthcare Diagnostics, Inc. |
| Oct 8, 2012 | Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method ... | Siemens Healthcare Diagnostics has confirmed the potential for falsely elevated results with IRON... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 9, 2012 | Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridg... | Firm has received complaints from customers of "Abnormal Reaction" errors occurring on calibratio... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 3, 2012 | Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is ... | Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent ... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Jul 30, 2012 | Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital... | Firm has confirmed highter imprecision with the recalled lots on Beckman Coulter AU(R) Systems. ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 17, 2012 | Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K408... | Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) r... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Jul 17, 2012 | Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Hea... | Siemens Healthcare Diagnostics has confirmed that partial insertion of the power cord on the Dime... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 7, 2012 | EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informa... | There is a potential for the EasyLink system to display and transmit to the Laboratory Informatio... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 7, 2012 | Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classi... | The recalling firm has discovered that when using a Sysmex(R) CA-7000 or CA-1500 coagulation anal... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 7, 2012 | Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502... | Siemens has confirmed that the Stratus(R) CS Acute Care(TM) D-Dimer CalPak calibrator lots 502058... | Class III | 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.