Browse Device Recalls
530 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 530 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 530 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 28, 2018 | VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number... | The reagent pack exhibits the potential for an increased frequency of calibration failures. | Class II | Ortho-Clinical Diagnostics |
| Aug 12, 2018 | VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For i... | A deterioration of performance was identified with influenza type B Enzyme Immunoassay Kits with ... | Class II | The Binding Site Group, Ltd. |
| Aug 10, 2018 | Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CA... | Vials of the autoHDL/LDL Calibrator were shipped without a vial label. | Class III | Medtest Holdings, Inc. |
| Aug 8, 2018 | Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement ... | Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values... | Class II | Magellan Diagnostics, Inc. |
| Jul 25, 2018 | Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists... | After running the calibration curve, the recovery of the IgM kit control results decrease demonst... | Class II | The Binding Site Group, Ltd. |
| Jul 24, 2018 | ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: ... | A potential bias was identified with certain kits compared to the internal standards. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 24, 2018 | Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: ... | A potential bias was identified with certain kits compared to the internal standards. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 24, 2018 | Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vit... | A potential bias was identified with certain kits compared to the internal standards. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jun 27, 2018 | BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage... | The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident... | Class II | bioMerieux, Inc. |
| Jun 27, 2018 | BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product... | The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident... | Class II | bioMerieux, Inc. |
| Jun 27, 2018 | BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage... | The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident... | Class II | bioMerieux, Inc. |
| Jun 25, 2018 | Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMa... | Calibration setting was incorrectly entered during manufacturing causing the optical coherence to... | Class II | Carl Zeiss Meditec AG |
| May 17, 2018 | The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Contro... | An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibr... | Class II | Intuitive Surgical, Inc. |
| Apr 19, 2018 | Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme... | The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end o... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 19, 2018 | Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immu... | The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end o... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 9, 2018 | VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux S... | Invalid calibration with low calibrator S1 while using the product. | Class II | BioMerieux SA |
| Mar 27, 2018 | ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on A... | Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results ca... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 23, 2018 | Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Num... | Medtronic has become aware that certain lots of the VCLAS 3MM, 10MM, and 15MM laser diffusing fib... | Class II | Medtronic Navigation, Inc. |
| Mar 12, 2018 | Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10... | Incorrect calibrator level listed in qualitative calibration steps | Class III | Siemens Healthcare Diagnostics, Inc. |
| Mar 12, 2018 | Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 104... | Incorrect calibrator level listed in qualitative calibration steps | Class III | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2018 | Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The produc... | The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient re... | Class II | Tosoh Bioscience Inc |
| Mar 1, 2018 | VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is... | Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS... | Class II | bioMerieux, Inc. |
| Jan 11, 2018 | VITROS Immunodiagnostic Products TSH Reagent Pack | VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signa... | Class III | Clinical Diagnostic Systems |
| Dec 15, 2017 | Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer in... | The calibration for the affected batch of analyzers was incorrectly set during the manufacturing ... | Class II | Quidel Corporation |
| 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 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. |
| Aug 30, 2017 | Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the... | The device had an incorrect printed calibration value on the calibration certificate. | Class II | Carl Zeiss Meditec AG |
| Aug 24, 2017 | Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter ... | Unpaired lots of AU lyophilized chemistry calibrator level 1 and 2 have been distributed. Calibra... | Class II | Beckman Coulter Inc. |
| Jul 19, 2017 | K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY... | The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots... | Class II | Kamiya Biomedical Company, LLC |
| Jun 7, 2017 | Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDO... | Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. Th... | Class II | Randox Laboratories Ltd. |
| Jun 1, 2017 | VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, Rx Only, 115/230V - 60/... | Potential inaccurate calibration by service depot repair, which could contribute to patients bein... | Class II | Solta Medical Inc |
| Jun 1, 2017 | VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300V... | Potential inaccurate calibration by service depot repair, which could contribute to patients bein... | Class II | Solta Medical Inc |
| May 22, 2017 | MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. ... | Reagent 1 component may result in Quality Control values shifting out of acceptable range, which ... | Class II | Sentinel CH SPA |
| May 15, 2017 | Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: ... | The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 w... | Class II | Beckman Coulter Inc |
| May 12, 2017 | MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Produ... | Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet produc... | Class II | Mesa Laboratories, Inc. |
| Apr 18, 2017 | ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator... | ELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE CALIBRATOR... | Class II | ELITech Clinical Systems SAS |
| Apr 11, 2017 | EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containin... | Patient results determined using this calibrator lot might deviate up to 20%. Controls might not ... | Class II | Medica Corporation |
| Mar 10, 2017 | Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C | Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibratio... | Class II | Beckman Coulter Inc. |
| Mar 7, 2017 | VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 215... | Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagen... | Class II | ORTHO-CLINICAL DIAGNOSTICS |
| 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. |
| 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 |
| 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 21, 2016 | Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. ... | Mallinckrodt discovered that some devices may have been manufactured with an out-of-tolerance man... | Class II | INO Therapeutics (dba Ikaria) |
| Oct 28, 2016 | Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, L... | A change in the calibration curve causing an increase in false prozone flags. | Class II | The Binding Site Group, Ltd. |
| Oct 26, 2016 | Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the qu... | There may be a loss of separation between Calibrators A and B which may impact the assay calibrat... | Class III | Diagnostic Hybrids, Inc. |
| Oct 20, 2016 | Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a... | A product issues happens for RF projection images. If user measures on RF image, .cal (Calibratio... | Class II | Merge Healthcare, 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. |
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.