The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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8551–8575 of 40056

  • SevereFDA (Devices)·Z-0548-2024·2023-12-20

    CereLink ICP Extension Cable Recalled for Out of Range Readings

    Integra LifeSciences is recalling CereLink ICP Extension Cables due to a design defect causing out of range readings. The Class I recall affects 4,941 units distributed nationwide and internationally.

    Product
    CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part of the same SKU.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0505-2024·2023-12-20

    Philips Panorama MR System Structural Failure Risk from Helium Gas Pressure

    Philips Panorama 1.0T MR Systems (Models 781250, 781350) may experience structural failure during helium quench events, releasing pressurized gas and debris that could cause helium exposure, asphyxia, and injury to patients and operators.

    Product
    Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-0534-2024·2023-12-20

    Medline Leg Bags Recalled Due to Undeclared Latex

    Medline Industries has recalled approximately 19,406 leg bags due to undeclared latex. Patients with latex allergies may experience allergic reactions from skin contact with the device.

    Product
    Medline Leg bag, REF DYND12578
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0528-2024·2023-12-20

    Sterile PVP Medical Solution Recalled for Non-Sterile Contents

    Medline Industries is recalling 700 units of Sterile PVP solution because the labeling claims sterility but the contents are non-sterile. The affected products were distributed nationwide in eight states.

    Product
    STERILE PVP, REF DYNDA1649
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0543-2024·2023-12-20

    Medical Diagnostic System Recall Due to Software-Related System Freezes and Delayed Results

    Ortho-Clinical Diagnostics is recalling the VITROS 3600 Immunodiagnostic System due to software issues causing system freezes and delayed test result reporting. The delays could affect patient care when rapid results are critical.

    Product
    VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0519-2024·2023-12-20

    Para-Pak Clean Vial Stool Collection Kits Recalled for Manufacturing Defect

    Meridian Bioscience is recalling Para-Pak Clean Vials used for stool specimen collection due to a manufacturing defect that increases leakage risk and may expose users to biological hazards.

    Product
    Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0529-2024·2023-12-20

    Medline PVP Solution Recalled Due to Mislabeled Sterility

    Medline PVP Solution (REF DYNDA1858) is being recalled because it is labeled as sterile but contains non-sterile contents. 1,950 units are affected.

    Product
    PVP SOLUTION SING STRL, REF DYNDA1858
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0517-2024·2023-12-20

    Brachytherapy Treatment Planning Software Recalled Due to Measurement Inaccuracy

    SagiPlan 2.2 brachytherapy treatment planning software is recalled due to a software malfunction that may round numerical values, potentially causing inaccurate treatment measurements.

    Product
    SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0535-2024·2023-12-20

    Medical Device Recall: Medline Leg Bag with Undeclared Latex

    Medline is recalling 144 Leg bag devices (model REF URO12573) distributed in the US and Panama due to undeclared latex that may cause allergic reactions in sensitive users.

    Product
    Medline Leg bag, REF URO12573
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0525-2024·2023-12-20

    Medline Sterile PVP Solution Recalled Due to Non-Sterile Contents

    Medline Industries is recalling 8,250 units of sterile PVP solution distributed nationwide because the contents are non-sterile despite being labeled as sterile.

    Product
    STERILE PVP SOLUTION, REF DYNDA1907
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0554-2024·2023-12-20

    Sensica Urine Output System displays incorrect timestamps when connected to WiFi

    The Sensica Urine Output System (SCCS1002) displays incorrect timestamps and monitoring data when connected to WiFi or internet due to a time synchronization issue. This malfunction affects the accuracy of patient monitoring records.

    Product
    Sensica Urine Output System, Catalog Number SCCS1002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0520-2024·2023-12-20

    Medical Device Recall: Para-Pak Zn-PVA Stool Collection Vials for Leakage Risk

    Meridian Bioscience is recalling Para-Pak Zn-PVA stool specimen collection vials due to a manufacturing defect that may cause leakage and risk exposure to biological hazards.

    Product
    Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0531-2024·2023-12-20

    Povidone Solution Labeled Sterile Despite Non-Sterile Contents

    Medline Industries recalls 300 units of Sterile Povidone (REF DYNDA2061) after discovering the solution inside foil sachets is non-sterile despite sterile labeling. Affected lots are distributed across eight states.

    Product
    STERILE POVIDONE, REF DYNDA2061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0552-2024·2023-12-20

    GE Definium Tempo X-Ray System Bolts May Loosen and Fall

    Incorrect bolt torque on GE Definium Tempo X-ray systems may cause the overhead tube suspension assembly to fall. No injuries have been reported, but GE recommends immediate inspection of affected systems.

    Product
    The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD sy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0527-2024·2023-12-20

    Sterile Prep Stick Recall: Non-Sterile Contents Despite Sterile Labeling

    Medline Industries is recalling sterile prep sticks (REF DYNDA1134) labeled as sterile that contain non-sterile solution, posing infection risk in medical procedures.

    Product
    STERILE STERILE PREP STICK, REF DYNDA1134
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0546-2024·2023-12-20

    Chemistry System Software Malfunction Causes Freezes and Result Reporting Delays

    Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to software issues causing screen freezes and system unresponsiveness. The problems can delay reporting of patient test results, including critical or STAT assays.

    Product
    VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2024·2023-12-20

    Non-sterile Betadine solution labeled and distributed as sterile

    Medline Industries is recalling 1,800 units of Sterile Betadine (Ref DYNDA1998) because the foil sachet contents are non-sterile, despite labeling that claims sterility. The recall affects units nationwide in eight states.

    Product
    STERILE BETADINE, REF DYNDA1998
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0557-2024·2023-12-20

    Olympus tracheal intubation fiberscope recalled due to suction flow specification issue

    Olympus tracheal intubation fiberscopes are being recalled because the manufacturer lacks adequate data confirming the suction flow rate meets device specifications. No injuries have been reported.

    Product
    TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0524-2024·2023-12-20

    Medical Device Recall: PHYSICA HPS Tibial Liner Incorrect Labeling

    Limacorporate is recalling 33 PHYSICA HPS Tibial Liner units distributed in the U.S. due to incorrect product labeling. No adverse events have been reported.

    Product
    PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0522-2024·2023-12-20

    SynchroMed Model A10 Infusion Pump Software Display Error

    Medtronic is recalling 2,543 SynchroMed Model A10 infusion pumps with software version 1.1.300 due to missing decimal separators on parameter display screens. The omission could lead to misinterpretation of dosing parameters.

    Product
    Medtronic SynchroMed, Model A10
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0553-2024·2023-12-20

    X-ray system overhead suspension components may fall due to incorrect bolt torque

    GE HealthCare Definium Tempo and Tempo Pro X-ray systems may have been assembled with incorrect bolt torque, creating a risk that Overhead Tube Suspension components could fall.

    Product
    The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD sy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0555-2024·2023-12-20

    CARDIOHELP-i Heart-Lung Support System: Incorrectly Documented Factory Settings

    The CARDIOHELP-i Heart-Lung Support System is recalled because factory settings were incorrectly described in the manual. Healthcare providers should verify device settings with the manufacturer.

    Product
    CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass Part Number: 701072780, (CARDIO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0533-2024·2023-12-20

    FDA Recalls Medline Leg Bags for Undeclared Latex

    Medline leg bags contain undeclared latex, creating a risk for users with latex allergies. The company is recalling 28,942 devices distributed in the US and Panama.

    Product
    Medline Leg bag, REF DYND12574
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0532-2024·2023-12-20

    Shoulder Implant Recall: RSP Glenoid Baseplate Assembly Defect

    Encore Medical recalls RSP Glenoid Baseplate shoulder implants due to a manufacturing defect in the hex engagement mechanism. The defect could prevent proper installation of the device.

    Product
    RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0518-2024·2023-12-20

    Iconix Knotless 1.4mm Anchor recalled due to inserter failure risk

    Riverpoint Medical is recalling Iconix Knotless 1.4mm surgical anchors because the inserter can fail or bend when used in hard bone, potentially damaging sutures during insertion or use.

    Product
    Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF 3911-714-521 The Iconix Knotless anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wri
    Category
    Medical Device
    Distribution
    Distributed nationwide