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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7726–7750 of 13683

  • HighFDA (Devices)·Z-0545-2024·2023-12-20

    Laboratory Diagnostic System Software Defects Cause System Freezes and Result Delays

    The VITROS 5600 laboratory analyzer is being recalled due to software issues causing screen freezes and printer disconnections that delay test result reporting, potentially affecting patient care.

    Product
    VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0
    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-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
    17 states
  • 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-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-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-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-0544-2024·2023-12-20

    FDA Recalls VITROS 4600 Chemistry System for Software-Related Freezes

    Ortho-Clinical Diagnostics is recalling 51 units of the VITROS 4600 Chemistry System due to software defects causing system freezes and disconnections that could delay critical test result reporting.

    Product
    VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0547-2024·2023-12-20

    Laboratory Diagnostic System Software Malfunction Causes System Freezes and Delays

    Ortho-Clinical Diagnostics recalls 216 VITROS XT 7600 laboratory systems running Software Version 3.8.0 due to software issues causing screen freezes and unresponsiveness. The defects delay test result reporting and could postpone patient treatment.

    Product
    VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
    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-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-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-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-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-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-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
  • HighFDA (Devices)·Z-0523-2024·2023-12-20

    Collision Sensor Malfunction in Siemens ARTIS Icono Fluoroscopic X-Ray System

    The ARTIS icono fluoroscopic x-ray system may falsely detect collisions for up to 30 minutes after startup, requiring manual override with reduced safety protection and limiting diagnostic use.

    Product
    ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
    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-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-0550-2024·2023-12-20

    Baxter Amia Peritoneal Dialysis Cycler Set: Cassette Integrity Test Alarm Failures

    Baxter is recalling 339,936 Amia peritoneal dialysis devices due to increased complaints of failure alarms for the Wet Cassette Integrity Test. This may prevent proper alerting during treatment.

    Product
    Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0526-2024·2023-12-20

    Sterile PVP Solution Kit Recalled for Non-Sterile Contents

    Medline STERILE PVP SLN KIT (Lot 21GBJ087) is recalled because its contents are non-sterile despite labeling stating sterile product. Consumers should stop use immediately.

    Product
    STERILE PVP SLN KIT, REF DYNDM1097
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • ModerateFDA (Devices)·Z-0509-2024·2023-12-20

    Spectranetics Turbo-Elite Atherectomy Catheters recalled due to labeling mismatch

    Spectranetics Corporation is recalling 1,239 Turbo-Elite Laser Atherectomy Catheters due to incorrect labeling where the exterior product box label does not match the internal pouch label.

    Product
    Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 420-006 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.4 RX REF 414-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1
    Category
    Medical Device
    Distribution
    Distributed nationwide