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Browse Device Recalls

1,361 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,361 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 1,361 FDA device recalls in NY.

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DateProductReasonClassFirm
Jul 10, 2023 Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative d... Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could im... Class II Siemens Healthcare Diagnostics, Inc.
Jul 10, 2023 Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quanti... Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could im... Class II Siemens Healthcare Diagnostics, Inc.
May 19, 2023 Contour¿ next GEN Blood Glucose Monitoring System Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lo... Class II Ascensia Diabetes Care US, Inc.
May 18, 2023 VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro di... May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU). Class III Ortho-Clinical Diagnostics, Inc.
May 10, 2023 Walnut Wearable Smart Thermometer, intended for continuous chest temperature ... There have been reports of skin burns to children wearing the device. Class I BearCare, Inc.
May 8, 2023 VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VI... Potential to cause biased results in the upper end of the reportable range for the quantitative m... Class II Ortho-Clinical Diagnostics
Apr 6, 2023 Fisher Wallace Stimulator Models FW-100 and FW-200 If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, d... Class II Fisher Wallace Laboratories Inc.
Apr 5, 2023 ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibra... Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia C... Class II Siemens Healthcare Diagnostics, Inc.
Apr 5, 2023 Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calib... Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia C... Class II Siemens Healthcare Diagnostics, Inc.
Mar 16, 2023 ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol... There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) resul... Class II Siemens Healthcare Diagnostics, Inc.
Mar 16, 2023 Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10... There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) resul... Class II Siemens Healthcare Diagnostics, Inc.
Mar 2, 2023 NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgic... Not programmed in accordance with specification. The programming affects the RFID function and do... Class II Angiodynamics, Inc.
Feb 14, 2023 Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90 The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses ... Class II CooperVision, Inc.
Jan 30, 2023 Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test fo... Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Contr... Class II Siemens Healthcare Diagnostics, Inc.
Jan 30, 2023 DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For ... After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead ... Class II Carestream Health, Inc.
Jan 27, 2023 Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative dete... Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig)... Class II Siemens Healthcare Diagnostics, Inc.
Jan 27, 2023 Atellica CH Total Protein II- In vitro diagnostic use in the quantitative det... Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig)... Class II Siemens Healthcare Diagnostics, Inc.
Jan 27, 2023 Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative de... Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig)... Class II Siemens Healthcare Diagnostics, Inc.
Jan 27, 2023 Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quant... Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig)... Class II Siemens Healthcare Diagnostics, Inc.
Jan 26, 2023 Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (e... Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experi... Class II CooperVision, Inc.
Jan 26, 2023 Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear) Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experi... Class II CooperVision, Inc.
Dec 27, 2022 MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Con... Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor vis... Class II CooperVision, Inc.
Dec 7, 2022 IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMUL... Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit l... Class II Siemens Healthcare Diagnostics, Inc.
Dec 7, 2022 IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMUL... Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit l... Class II Siemens Healthcare Diagnostics, Inc.
Dec 5, 2022 Turbett Surgical Container, TS1200: Indicated for enclosing other medical dev... Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instr... Class II Turbett Surgical, Inc.
Dec 5, 2022 Turbett Surgical Container, TS1000: Indicated for enclosing other medical dev... Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instr... Class II Turbett Surgical, Inc.
Nov 18, 2022 Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction C... Suction ports may potentially be occluded on the affected devices. If this occurs, the affected d... Class II ConMed Corporation
Nov 17, 2022 VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quanti... Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPT... Class II Ortho-Clinical Diagnostics, Inc.
Oct 21, 2022 Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1 Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive compon... Class II Busse Hospital Disposables, Inc.
Oct 21, 2022 Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1 Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive compon... Class II Busse Hospital Disposables, Inc.
Sep 20, 2022 Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone ... Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the ... Class II Angiodynamics, Inc.
Sep 19, 2022 Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro di... Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the wors... Class II Siemens Healthcare Diagnostics, Inc.
Sep 19, 2022 Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnost... Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the wors... Class II Siemens Healthcare Diagnostics, Inc.
Aug 29, 2022 Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-... Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly ma... Class II Intersurgical Inc
Aug 10, 2022 VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55... OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimens... Class II Angiodynamics, Inc.
Jul 19, 2022 VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6... Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or... Class II Ortho-Clinical Diagnostics, Inc.
Jul 19, 2022 VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: ... Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or... Class II Ortho-Clinical Diagnostics, Inc.
Jun 28, 2022 Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitativ... Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Ir... Class II Siemens Healthcare Diagnostics, Inc.
Jun 24, 2022 ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000 An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5... Class III Zeiss, Carl Inc
Jun 23, 2022 Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and an... A race condition between the storage system and services database has the potential to revert edi... Class II DICOM Grid, Inc. d/b/a Ambra Health
May 26, 2022 Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ E... On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in th... Class II Ortho-Clinical Diagnostics, Inc.
Apr 14, 2022 Turbett Surgical Container, TS1500 Devices were subject to unapproved rework processes. Class II Turbett Surgical, Inc.
Apr 13, 2022 Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perfo... Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of... Class II Siemens Healthcare Diagnostics, Inc.
Apr 13, 2022 Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perfo... Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of... Class II Siemens Healthcare Diagnostics, Inc.
Apr 1, 2022 Turbett Surgical Container, TS1500 Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barr... Class II TURBETT SURGICAL, LLC
Mar 16, 2022 LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device... Users received sample collection kits that were assigned to another user. Incorrect shipping lab... Class II LetsGetChecked Inc.
Mar 15, 2022 CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R... Class II Graphic Controls Acquisition Corporation
Mar 15, 2022 CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R... Class II Graphic Controls Acquisition Corporation
Mar 15, 2022 CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R... Class II Graphic Controls Acquisition Corporation
Mar 15, 2022 CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R... Class II Graphic Controls Acquisition Corporation

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.