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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8526–8550 of 39932

  • 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-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-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-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-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-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-0521-2024·2023-12-20

    Cardinal Health Stool Transportation System Recalled for Vial Leakage

    Meridian Bioscience is recalling the Cardinal Health Clean Stool Transportation System due to a manufacturing defect that may cause Para-Pak vials to leak. Affected product: 38 cases with Lot Number 510020Q, distributed nationwide and to Italy.

    Product
    Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312
    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-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-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-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-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-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-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
  • 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
  • LowFDA (Devices)·Z-0556-2024·2023-12-20

    Medical Device Instructions Update Recall for Navik 3D Mapping System

    APN Health LLC is recalling the Navik 3D v2 3D Mapping System to update the product instructions for use. The firm initiated this voluntary recall.

    Product
    Navik 3D v2, REF NAVIK3D, 3D Mapping System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0420-2024·2023-12-13

    CARDIOHELP Emergency Drive Blockage May Impair Cardiac Blood Oxygenation

    The FDA is recalling CARDIOHELP Emergency Drive units due to potential blocking that impairs blood flow. Affected patients may experience ischemia and hypoxia from inappropriate low blood oxygen.

    Product
    CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0355-2024·2023-12-13

    Infusomat Administration Sets recalled for tubing dimension defects

    B. Braun Infusomat Administration Sets may have incorrect tubing dimensions that cause false air-in-line alarms, interrupting medication delivery. The defects may prevent critical medications from reaching patients.

    Product
    Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; 362033 UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; 362034 Priming volume: 19mL, le
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0459-2024·2023-12-13

    FDA Recalls Quantum TTC Biliary Balloon Dilators Due to Design Nonconformance

    Wilson-Cook Medical recalls 553 Quantum TTC Biliary Balloon Dilators that do not meet design specifications, creating risk of balloon detachment during endoscopic procedures.

    Product
    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0503-2024·2023-12-13

    Medical Catheter Set Recalled for Faulty Bonding Material

    CooperSurgical is recalling H/S ELLIPTOSPHERE CATH 5 FR Sets (169 units) due to incorrect bonding material that may cause component detachment or leakage, potentially delaying diagnostic procedures.

    Product
    Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes Model: 61-40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0508-2024·2023-12-13

    DJO EMPOWR Knee System Recall: Incorrect Device in Packaging

    Encore Medical is recalling 37 DJO surgical EMPOWR Porous Knee System SIZE 8 devices distributed nationwide because incorrect product components were packaged with certain units.

    Product
    DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0497-2024·2023-12-13

    Integra Cranial Access Kit recalled over outer packaging defect

    Integra LifeSciences recalled the Integra Cranial Access Kit (160 units) due to a defect in the outer packaging that can split and compromise device sterility, creating an infection risk for neurosurgical procedures.

    Product
    Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0454-2024·2023-12-13

    Red Light Therapy Bed Canopy Strut Detachment Risk Nationwide

    Thor Photomedicine is recalling six THOR NOVO GEN 2.0 XL whole body red light therapy beds due to ball stud component failure. The defect causes gas strut detachment, making the canopy difficult to lift.

    Product
    G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0461-2024·2023-12-13

    Quantum TTC Biliary Balloon Dilator Recalled for Balloon Detachment Risk

    Wilson-Cook Medical is recalling QUANTUM TTC BILIARY BALLOON DILATORS due to nonconforming devices that may detach during use. Detachment could require endoscopic retrieval and carries a risk of bleeding.

    Product
    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures of the biliary tree
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0490-2024·2023-12-13

    Blood Ketone Test Strips Recalled for False Negative Results

    Stanbio Laboratory is recalling STAT-Site M BHB Test Strips due to stability deterioration that causes false negative results. This defect may delay diagnosis and treatment of patients with conditions such as diabetic ketoacidosis.

    Product
    STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
    Category
    Medical Device
    Distribution
    Distributed nationwide