Browse Device Recalls

3,367 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,367 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 3,367 FDA device recalls in IL.

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DateProductReasonClassFirm
Apr 13, 2022 NaviCare Nurse Call System provides a comprehensive communication and info... Firm discovered a firmware memory leak with a supplier-manufactured component. Class II Baxter Healthcare Corporation
Apr 13, 2022 AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe Product labeled incorrectly. Class II Northgate Technologies, Inc.
Apr 13, 2022 Voalte Nurse Call System provides a comprehensive communication and inform... Firm discovered a firmware memory leak with a supplier-manufactured component. Class II Baxter Healthcare Corporation
Apr 1, 2022 Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular p... There is a potential for foreign matter. Class II Baxter Healthcare Corporation
Mar 15, 2022 PrisMax System, Product Code 955626 This correction is due to software anomalies occurring during use. If the operator initiates ther... Class II Baxter Healthcare Corporation
Mar 15, 2022 PrisMax System, Product Code 955724 This correction is due to software anomalies occurring during use. If the operator initiates ther... Class II Baxter Healthcare Corporation
Mar 15, 2022 PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701 This correction is due to software anomalies occurring during use. If the operator initiates ther... Class II Baxter Healthcare Corporation
Mar 15, 2022 Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves Product was distributed without being sterilized. Class II Cardinal Health 200, LLC
Mar 11, 2022 Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems There is a quality issue with the three bolts that hold the CT balancing weights, which could cre... Class II Siemens Medical Solutions USA, Inc.
Mar 9, 2022 Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box The mask cuff may disconnect from the device's breathing tube. Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 8, 2022 Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8... Product was improperly store which may cause a delay in results. Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 8, 2022 ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myogl... This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a cal... Class II Abbott Laboratories
Mar 8, 2022 Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes conta... The product was stored incorrectly due to improper storage controls which may lead to delayed res... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 4, 2022 Alinity m HBV Application Specification File (US and CE) There is a potential for misquantitation high results of negative samples. Class II Abbott Molecular, Inc.
Mar 4, 2022 Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride In... Sterility failure of the exterior of the syringe which may impact the device's ability to be laid... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 4, 2022 Alinity m HBV AMP Kit (US and CE) There is a potential for misquantitation high results for negative samples. Class II Abbott Molecular, Inc.
Feb 25, 2022 Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H9386... Product is mislabeled as self-righting Luer slip tip caps, yellow. Class II Baxter Healthcare Corporation
Feb 25, 2022 MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C448... Devices distributed lacked regulatory clearance. Class II Baxter Healthcare Corporation
Feb 23, 2022 (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degre... The finished device package did not contain the IFU. Class II Carefusion 2200 Inc
Feb 21, 2022 Liko Universal Twinbar 670 QRH, an accessory that can be used together with m... An incorrect center bolt was used in the assembly of the product which could result in a patient ... Class II Baxter Healthcare Corporation
Feb 15, 2022 VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021 Higher than normal "No Call Internal Control failures" due to a missing reagent within a small su... Class II Luminex Corporation
Feb 14, 2022 Compella Bariatric Bed System Potential damage to the power cord may cause the power conductors to be exposed, thereby creating... Class II Baxter Healthcare Corporation
Feb 14, 2022 Compella Therapy Air Supply Unit Potential damage to the power cord may cause the power conductors to be exposed, thereby creating... Class II Baxter Healthcare Corporation
Feb 11, 2022 Alinity m Integrated Reaction Units (IRU) There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by t... Class II Abbott Molecular, Inc.
Jan 25, 2022 meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit... The product was incorrectly shipped at room temperature rather than refrigerated. Class II MEDLINE INDUSTRIES, LP - Northfield
Jan 14, 2022 BUTLER Clear Dip, 12 bottles/case Product lacks premarket clearance. Class II Sunstar Americas, Inc.
Jan 10, 2022 RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component... The product does not have 510(k) clearance. Class I BASE 10 GENETICS INC
Jan 7, 2022 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482 Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... Class II Baxter Healthcare Corporation
Jan 7, 2022 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482 Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... Class II Baxter Healthcare Corporation
Jan 7, 2022 Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R... Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... Class II Baxter Healthcare Corporation
Jan 7, 2022 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... Class II Baxter Healthcare Corporation
Jan 7, 2022 Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code N... Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... Class II Baxter Healthcare Corporation
Jan 7, 2022 Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code N... Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... Class II Baxter Healthcare Corporation
Jan 7, 2022 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, R... Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... Class II Baxter Healthcare Corporation
Jan 7, 2022 Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pi... Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... Class II Baxter Healthcare Corporation
Jan 7, 2022 Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449 Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... Class II Baxter Healthcare Corporation
Jan 7, 2022 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, ... Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... Class II Baxter Healthcare Corporation
Jan 7, 2022 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... Class II Baxter Healthcare Corporation
Dec 29, 2021 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Pro... There is the potential for reduced or non-delivery of medication, in some cases without alerting ... Class I Baxter Healthcare Corporation
Dec 29, 2021 Baxter Spectrum IQ Infusion Pumps, Product code 3570009. There is the potential for reduced or non-delivery of medication, in some cases without alerting ... Class I Baxter Healthcare Corporation
Dec 29, 2021 MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes Micro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite. Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 20, 2021 bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventila... Potential cessation in ventilation can occur under specific conditions. Class I Vyaire Medical
Dec 15, 2021 CURAD REUSABLE GEL HOT/COLD PACK The product contains natural rubber latex but the label states that it does not. Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 6, 2021 Alinity m System, Part No. 08N53-002 There is an issue with the installation of updated camera firmware on the system. Class II Abbott Molecular, Inc.
Dec 6, 2021 Alinity m System, Part No. 08N53-002 There is a software defect that can cause the Amplification Detection clamp CLEAN position to be ... Class II Abbott Molecular, Inc.
Dec 6, 2021 Alinity m System, Part No. 08N53-002 There is a software issue associated with the ability to properly complete a Field Service Engine... Class II Abbott Molecular, Inc.
Dec 6, 2021 Alinity m System, Part No. 08N53-002 There is a potential for abnormal (non-sigmoidal) amplification curves. Class II Abbott Molecular, Inc.
Dec 1, 2021 Michels Transport Medium, 20ML Prefilled Cont Product stored incorrectly in temperature controlled setting instead of refrigeration. Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 1, 2021 Premier Rotaclone, Rx only Product stored incorrectly in temperature controlled setting instead of refrigeration. Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 1, 2021 HARDY DIAGNOSTICS CatScreen, 25dsk/vial Product stored incorrectly in temperature controlled setting instead of refrigeration. Class II MEDLINE INDUSTRIES, LP - Northfield

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.