Browse Device Recalls

1,398 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,398 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 1,398 FDA device recalls in NY.

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DateProductReasonClassFirm
Jul 22, 2025 Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitr... Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain p... Class II Trinity Biotech USA
Jul 9, 2025 VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261; Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Conditio... Class II Ortho-Clinical Diagnostics, Inc.
Jun 20, 2025 One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090. Potential contamination with small burrs, which if detach could be inhaled and result in potentia... Class II Intersurgical Inc
Jun 20, 2025 One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080. Potential contamination with small burrs, which if detach could be inhaled and result in potentia... Class II Intersurgical Inc
Jun 17, 2025 i-view video laryngoscope. Model Number: 8008000. The i-view video laryng... Potential for faulty devices as a result of depleted batteries. Class I Intersurgical Inc
Jun 16, 2025 Biofinity Toric Multifocal Contact Lens Lens blisters may have an incomplete or leaking seal which may render them unsterile. Class II CooperVision, Inc.
Jun 16, 2025 Biofinity XR Toric Contact Lens Lens blisters may have an incomplete or leaking seal which may render them unsterile. Class II CooperVision, Inc.
Jun 12, 2025 VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITR... Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than exp... Class II Ortho-Clinical Diagnostics, Inc.
Jun 10, 2025 VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 ... Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain... Class II Ortho-Clinical Diagnostics, Inc.
Jun 10, 2025 VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 sli... Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain... Class II Ortho-Clinical Diagnostics, Inc.
Jun 10, 2025 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain... Class II Ortho-Clinical Diagnostics, Inc.
Jun 10, 2025 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain... Class II Ortho-Clinical Diagnostics, Inc.
Jun 4, 2025 ADVIA¿ 120/2120/2120i SETpoint Calibrator Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematol... Class II Siemens Healthcare Diagnostics, Inc.
Jun 4, 2025 ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control) Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematol... Class II Siemens Healthcare Diagnostics, Inc.
Jun 4, 2025 ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematol... Class II Siemens Healthcare Diagnostics, Inc.
Jun 4, 2025 ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control) Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematol... Class II Siemens Healthcare Diagnostics, Inc.
May 22, 2025 Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN):... Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality ... Class II Siemens Healthcare Diagnostics, Inc.
May 9, 2025 Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalo... A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent pa... Class II Ortho-Clinical Diagnostics, Inc.
May 9, 2025 Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog... a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent pa... Class II Ortho-Clinical Diagnostics, Inc.
May 9, 2025 Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/C... a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent pa... Class II Ortho-Clinical Diagnostics, Inc.
Apr 21, 2025 BIB Balloon in Balloon Dilatation Catheter. Model Number: 420 Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub... Class II Numed Inc
Apr 14, 2025 VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, o... Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and ca... Class II Ortho-Clinical Diagnostics, Inc.
Apr 11, 2025 iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Syste... Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing. Class I Medical Depot Inc.
Mar 24, 2025 Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetell... It was determined that there could be a false positive rate of up to 16.7% for the affected lots ... Class II Ortho-Clinical Diagnostics, Inc.
Mar 11, 2025 Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN):... Incorrect software flagging may occur for the assay that may potentially lead to an erroneous res... Class II Siemens Healthcare Diagnostics, Inc.
Feb 28, 2025 Phoroptor VRx Digital Refraction System Model Numbers: 16242 The head of the phoropter head could come loose and potentially detach due to a default in the as... Class II Reichert, Inc.
Feb 28, 2025 Phoroptor VRx Digital Refraction System Model Numbers: 16241 The head of the phoropter head could come loose and potentially detach due to a default in the as... Class II Reichert, Inc.
Feb 27, 2025 Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Conta... a limited number of lots were manufactured with an incorrect cylinder power. Class II CooperVision, Inc.
Feb 4, 2025 IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UP... Product is mislabeled with the incorrect fill volume. Class II Angiodynamics, Inc.
Dec 19, 2024 Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/... The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if... Class II Ortho-Clinical Diagnostics, INc.
Dec 19, 2024 Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalo... The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the S... Class II Ortho-Clinical Diagnostics, INc.
Dec 19, 2024 Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Cat... The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if th... Class II Ortho-Clinical Diagnostics, INc.
Dec 5, 2024 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cau... Class II QUIDEL ORTHO
Dec 5, 2024 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cau... Class II QUIDEL ORTHO
Nov 25, 2024 AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-20... Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due ... Class II Angiodynamics, Inc.
Nov 4, 2024 Atellica CI Analyzer. Catalog Numbers: 10947347. Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on th... Class II Siemens Healthcare Diagnostics, Inc.
Oct 21, 2024 Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain a... A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 o... Class II Siemens Healthcare Diagnostics, Inc.
Oct 21, 2024 Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantita... Potential for falsely depressed auto-diluted results for samples above the measuring interval of... Class II Siemens Healthcare Diagnostics, Inc.
Oct 11, 2024 VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively meas... May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, show... Class II Ortho-Clinical Diagnostics, Inc.
Sep 16, 2024 ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ... Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variab... Class II ImaCor Inc.
Aug 29, 2024 BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction ... Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience ... Class II CooperVision, Inc.
Aug 29, 2024 Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the cor... Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience ... Class II CooperVision, Inc.
Aug 21, 2024 ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (5... Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the ... Class II Siemens Healthcare Diagnostics, Inc.
Aug 21, 2024 Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500... Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the ... Class II Siemens Healthcare Diagnostics, Inc.
Aug 15, 2024 ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the q... Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeti... Class II Siemens Healthcare Diagnostics, Inc.
Aug 15, 2024 Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quanti... Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeti... Class II Siemens Healthcare Diagnostics, Inc.
Jul 29, 2024 ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material ... The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lo... Class II Siemens Healthcare Diagnostics, Inc.
Jul 29, 2024 Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Numb... The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lo... Class II Siemens Healthcare Diagnostics, Inc.
Jul 10, 2024 The VITROS XT Chemistry Products ALB-TP Slides is a single device that contai... The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB... Class II Ortho-Clinical Diagnostics, Inc.
Jul 3, 2024 VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the ... Class II Ortho-Clinical 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.