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.

Filters

Agency

All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

1–25 of 12223

  • CriticalFDA (Devices)·Z-2604-2026·2026-07-08

    Omnipod DASH Pod insulin pump affected by external cannula damage

    Insulet Corporation is recalling Omnipod DASH Pods worldwide due to external soft cannula damage during manufacturing that can cause insulin to leak around the pod instead of being delivered. This may lead to high blood glucose levels and, in severe cases, diabetic ketoacidosis or death.

    Product
    Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). 2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod). 3. BLE-I1-529 (10-Pack), BLE-I1-520 (Single Pod). 4. BLE-C1-529 (10-Pack), BLE-C1-520 (Single
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2551-2026·2026-07-08

    Hillrom VOLARA System patient circuits recalled for nebulizer cup leakage

    Baxter Healthcare is recalling Hillrom VOLARA System patient circuits due to reports of air and medication leakage from the nebulizer cup, which can cause oxygen level drops and ineffective medication delivery.

    Product
    Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2619-2026·2026-07-08

    DSAEK Pack-RX surgical kits recalled for bacterial contamination

    Windstone Medical Packaging is recalling 1,080 DSAEK Pack-RX surgical convenience kits containing Webcol Large Alcohol Prep Pads contaminated with Paenibacillus phoenicis bacteria discovered during a sterilization audit.

    Product
    A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2621-2026·2026-07-08

    Preop Kit-NS surgical kits recalled for bacterial contamination

    A M S Preop Kit-NS surgical convenience kits are being recalled due to contamination with Paenibacillus phoenicis bacteria discovered during sterilization testing. The kits were distributed nationwide in PA, GA, CA, and WA.

    Product
    A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2550-2026·2026-07-08

    Hillrom VOLARA System patient circuits recalled for nebulizer leakage risk

    Baxter Healthcare is recalling Hillrom VOLARA System patient circuits due to reports of air and medication leakage from the nebulizer cup, which can reduce oxygen levels and prevent proper medication delivery.

    Product
    Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2672-2026·2026-07-08

    GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Recall

    W. L. Gore & Associates is recalling 467 GORE TAG Thoracic Branch Endoprosthesis Side Branch Components worldwide due to risk of catheter separation during deployment.

    Product
    GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB121706A, TSB122006A EMEA Countries, Australia, New Zealand:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2463-2026·2026-07-08

    Ventilator breathing circuit sets may obstruct exhalation valve

    Hamilton Medical AG is recalling coaxial breathing circuit sets used with three ventilator models because membranes may stick to the expiratory valve body, preventing proper gas exhalation and potentially causing inadequate ventilation.

    Product
    Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2644-2026·2026-07-08

    Cyberknife Treatment Delivery System Collimator Docking and Fall Hazard Recall

    Accuray Incorporated is recalling Cyberknife Treatment Delivery Systems with the Xchange Robotic Collimator Changer because a collimator may fail to fully dock and fall from the housing if room-control pendant motion is initiated while the system interlock is bypassed.

    Product
    Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2640-2026·2026-07-08

    Cyberknife Treatment Delivery System Collimator Docking Failure Risk

    Accuray Incorporated is recalling Cyberknife Treatment Delivery Systems equipped with the Xchange Robotic Collimator Changer due to a risk that the collimator may not fully dock and could fall from the housing if the in-room control pendant is used.

    Product
    Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2622-2026·2026-07-08

    Surgical Convenience Kit Recalled for Bacterial Contaminant in Alcohol Prep Pads

    Windstone Medical Packaging is recalling AMS Dr. Lewin Pack surgical convenience kits (45 units) distributed nationwide because they contain Webcol alcohol prep pads contaminated with Paenibacillus phoenicis bacteria.

    Product
    A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2605-2026·2026-07-08

    Omnipod Eros Pod Insulin Delivery Failure Risk

    Insulet Corporation is recalling Omnipod (Eros) Pod units due to external soft cannula damage during manufacturing that can cause insulin leakage instead of delivery to the user. High blood glucose levels and serious complications including diabetic ketoacidosis (DKA) or death may result from under-delivery of insulin.

    Product
    Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). 2. ZXR425 (10-Pack), ZXR420 (Single Pod). 3. ZXP425 (10 Pack), ZXP420 (Single Pod).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2620-2026·2026-07-08

    Thyroid FNA Pack-RX Surgical Kit Recalled for Bacterial Contamination

    Windstone Medical Packaging is recalling AMS Thyroid FNA Pack-RX surgical kits due to contamination with Paenibacillus phoenicis bacteria found in included Webcol alcohol prep pads.

    Product
    A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2624-2026·2026-07-08

    Medtronic Harmony Delivery Catheter System Distal Tip Detachment Risk

    Medtronic is recalling certain lots of the Harmony Delivery Catheter System due to a manufacturing issue that may cause the distal tip to detach from the delivery system during procedures.

    Product
    Medtronic Harmony Delivery Catheter System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2632-2026·2026-07-08

    CRE Wireguided 6-8mm 240cm Medical Device Recall Worldwide

    Boston Scientific Corporation is recalling the CRE Wireguided 6-8mm 240cm device worldwide due to a potential sterile breach of the packaging pouches.

    Product
    CRE Wireguided 6-8mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2607-2026·2026-07-08

    Medline Convenience Kits with Swan-Ganz Catheters Recalled for Defects

    Medline is recalling convenience kits containing Swan-Ganz catheters due to failures of the proximal injectate lumen hub that can cause leaks, lumen damage, and breakage, potentially resulting in infection, medication loss, or blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G HEART A DYNJ903465K OPEN HEART DYNJ909090G SILVER CROSS OPEN HEART DYNJ906102M VPH OPEN HEART DYNJ902664M DYNJ902664N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2610-2026·2026-07-08

    Medline Convenience Kits with Recalled Swan-Ganz Catheters

    Medline Convenience kits containing Swan-Ganz catheters are being recalled due to leaks and breakage of the proximal injectate lumen hub, which may lead to infection, medication loss, and blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET UP DYNJ905503D DYNJ905503F DYNJ905503G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2634-2026·2026-07-08

    Boston Scientific CRE Wireguided Medical Device Recall Sterile Breach

    Boston Scientific is recalling CRE Wireguided 10-12mm 240cm medical devices due to a potential sterile breach in the product packaging. The breach could compromise device sterility and affect patient safety.

    Product
    CRE Wireguided 10-12mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2603-2026·2026-07-08

    Omnipod 5 Insulin Infusion Pods Recalled for External Cannula Damage

    Insulet Corporation is recalling approximately 4.9 million Omnipod 5 insulin pods due to external soft cannula damage during manufacturing that can cause insulin leakage and under-delivery, potentially leading to high blood glucose and serious diabetic complications.

    Product
    Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). 4. OMNI-I1-6220. 5. OMNI-I1-6720. 6. BLE-H1-529 (10-Pack), BLE-H1-520 (Single Pod).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2615-2026·2026-07-08

    Reprocessed Electrophysiology Catheters Recalled for Residual Particles

    Medline Industries is recalling reprocessed electrophysiology and ultrasound catheters with residual particles that may cause inflammation, infection, or blood clots if contacted with blood or the heart.

    Product
    Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2549-2026·2026-07-08

    Hillrom VOLARA P.CIRCUIT Medical Device Nebulizer Cup Leakage Recall

    Baxter Healthcare Corporation is recalling the Hillrom VOLARA P.CIRCUIT 5KIT medical device due to reports of air and medication leakage from the nebulizer cup, which can reduce oxygen levels and compromise medication delivery.

    Product
    Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2548-2026·2026-07-08

    Hillrom VOLARA System P.CIRCUIT KIT Medical Device Recall for Oxygen Drop Risk

    Baxter Healthcare is recalling the Hillrom VOLARA System P.CIRCUIT KIT (Model REF M08085) due to reports of air and medication leakage from the nebulizer cup, which can cause oxygen level drops and reduce treatment effectiveness.

    Product
    Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2606-2026·2026-07-08

    Medline Convenience Kits with Swan-Ganz Catheters Recalled

    Medline Industries is recalling convenience kits containing Swan-Ganz catheters due to leaks and breakage of the proximal injectate lumen hub, which may cause infection, medication loss, or blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2647-2026·2026-07-08

    RayCare 2024A SP4 Oncology System Beam Set Delivery Note Data Loss

    RayCare 2024A SP4 oncology information system may lose data or fail to notify users when beam set delivery notes are modified simultaneously or updated during treatment sessions.

    Product
    RayCare 2024A SP4. Oncology Information Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2618-2026·2026-07-08

    Medacta Short Monobloc Stem Broaches Surgical Instruments Shoulder Implant

    Medacta USA is recalling Short Monobloc Stem Broaches used in shoulder replacement surgery due to positioning misalignment that may increase risk of fracture in the upper arm bone.

    Product
    Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.01.10.0974, 12/04.01.10.0975, 13/04.01.10.0976, 14/04.01.10.0977, 15/04.01.10.0978, 16/04.01.10.0979 Part of Medacta Shoulder System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2670-2026·2026-07-08

    Radius VSM ECG Pre-connected Set Recalled for Incorrect Heart Rate Detection

    Masimo Corporation is recalling Radius VSM ECG pre-connected sets because the ECG electrode assembly may incorrectly detect extreme bradycardia or tachycardia and trigger false alarms on patients with normal heart rates, potentially distracting clinicians from true positive alarms and delaying treatment.

    Product
    Radius VSM ECG pre-connected Set, REF: 4842, 4695
    Category
    Medical Device
    Distribution
    Distributed nationwide