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 |
|---|---|---|---|---|
| Jun 28, 2013 | ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04... | Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 A... | Class III | Siemens Healthcare Diagnostics, Inc |
| Jun 26, 2013 | PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog N... | Customers complained of a positive bias in patient results on the IMMULITE/ IMMULITE 1000 and the... | Class II | Siemens Healthcare Diagnostics |
| Jun 26, 2013 | ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . ... | The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When th... | Class II | Siemens Healthcare Diagnostics |
| Jun 25, 2013 | ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN... | ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for t... | 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 14, 2013 | ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro ... | iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability | Class II | Siemens Healthcare Diagnostics, Inc |
| May 14, 2013 | ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic ... | iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability | Class II | Siemens Healthcare Diagnostics, Inc |
| May 14, 2013 | ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 104936... | iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability | Class II | Siemens Healthcare Diagnostics, Inc |
| May 14, 2013 | ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitr... | iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability | Class II | Siemens Healthcare Diagnostics, Inc |
| May 10, 2013 | IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L... | A rare variant of TSH, identified in a small cluster of patients, is not detected. | Class II | Siemens Healthcare Diagnostics, Inc |
| May 10, 2013 | Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitative... | A rare variant of TSH, identified in a small cluster of patients, is not detected. | Class II | Siemens Healthcare Diagnostics, Inc |
| May 10, 2013 | Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to... | A rare variant of TSH, identified in a small cluster of patients, is not detected. | Class II | Siemens Healthcare Diagnostics, Inc |
| May 10, 2013 | Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intende... | A rare variant of TSH, identified in a small cluster of patients, is not detected. | 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 10, 2013 | ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06... | A rare variant of TSH, identified in a small cluster of patients, is not detected. | Class II | Siemens Healthcare Diagnostics, Inc |
| May 10, 2013 | IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2... | A rare variant of TSH, identified in a small cluster of patients, is not detected. | 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 13, 2013 | ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For ... | Negative bias in patient samples for Vitamin D | Class II | Siemens Healthcare Diagnostics, Inc |
| Mar 13, 2013 | ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For ... | Negative bias in patient samples for Vitamin D | Class II | Siemens Healthcare Diagnostics, Inc |
| Mar 13, 2013 | ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For ... | Negative bias in patient samples for Vitamin D | Class II | Siemens Healthcare Diagnostics, Inc |
| Mar 13, 2013 | ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For... | Negative bias in patient samples for Vitamin D | 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 26, 2013 | CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number... | Device with Sample Interference Notes (SIN) enabled not cleared for US marketing. | 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 28, 2012 | Immunoradiometric assay. Device is an immunoradiometric assay designed for... | The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of do... | Class III | Siemens Healthcare Diagnostics |
| Nov 28, 2012 | Immunoradiometric assay. | The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of do... | Class III | Siemens Healthcare Diagnostics |
| Nov 28, 2012 | Immunoradiometric assay. Device is an immunoradiometric assay designed for... | The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of do... | Class III | Siemens Healthcare Diagnostics |
| 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. |
| Nov 21, 2012 | Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemis... | When these lots of control material are reconstituted, the positive control solution leukocyte re... | Class III | Siemens Healthcare Diagnostics Inc |
| Nov 21, 2012 | Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek... | When these lots of control material are reconstituted, the positive control solution leukocyte re... | Class III | Siemens Healthcare Diagnostics Inc |
| Nov 21, 2012 | Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix¿ Positive and... | When these lots of control material are reconstituted, the positive control solution leukocyte re... | Class III | Siemens Healthcare Diagnostics Inc |
| Nov 21, 2012 | Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N ... | When these lots of control material are reconstituted, the positive control solution leukocyte re... | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 21, 2012 | Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (... | When these lots of control material are reconstituted, the positive control solution leukocyte re... | Class III | Siemens Healthcare Diagnostics Inc |
| Nov 21, 2012 | Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M ... | When these lots of control material are reconstituted, the positive control solution leukocyte re... | 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.