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.

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DateProductReasonClassFirm
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.