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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11626–11650 of 13748

  • HighFDA (Devices)·Z-1206-2022·2022-06-08

    Medtronic cardiac catheter system recalled due to sterility barrier defect

    Medtronic recalls its C304-HIS cardiac catheter device due to potential sterility barrier defects in certain manufacturing lots. Approximately 1,385 devices distributed worldwide were affected.

    Product
    The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to facilitate deflectable catheter passage, and a guide catheter slitter to remove
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1155-2022·2022-06-08

    Swab Drug Products Recalled Due to Manufacturing Validation Uncertainty

    Convenience kits containing swab/swabstick drug products are being recalled due to uncertainty about whether test methods used during manufacturing adequately validated the products. Affected products include 80 units distributed nationwide.

    Product
    Epidural Tray Catalog 1577
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1188-2022·2022-06-08

    Busse Convenience Kits Recalled Due to Manufacturing Test Validation Uncertainty

    Busse Hospital Disposables is recalling convenience kits containing swab and swabstick products due to uncertainty regarding the adequacy of manufacturing test method validation. Affected lot numbers are 2110127 and 2110269.

    Product
    SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1174-2022·2022-06-08

    Single Shot Epidural Tray Kits Recalled Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables recalls Single Shot Epidural Tray kits due to uncertainty about the adequacy of test method validation in manufacturing. No illnesses reported.

    Product
    Single Shot Epidural Tray - 18G Catalog Number: 8139R2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1176-2022·2022-06-08

    Core Biopsy Tray Recall Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Core Biopsy Trays (Catalog 8673R4) distributed nationwide because the test methods used to validate manufacturing processes may not have been adequately validated. The affected 285 units may lack proper quality verification.

    Product
    Core Biopsy Tray Catalog Number: 8673R4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1158-2022·2022-06-08

    Nerve Block Tray Recalled Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables recalled Nerve Block Tray units (catalog #8415) containing swab components due to uncertainty about adequate test method validation. The recall affects 420 units distributed nationwide.

    Product
    Nerve Block Tray Catalog Number: 8415
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1172-2022·2022-06-08

    Single Shot Epidural Tray recalled due to inadequate test method validation

    Busse Hospital Disposables is recalling Single Shot Epidural Trays because swab components from Professional Disposables International were manufactured with unvalidated test methods.

    Product
    Single Shot Epidural Tray Catalog Number: 6797R2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1187-2022·2022-06-08

    Busse Convenience Kit Swab Products Recalled Due to Manufacturing Test Validation Issue

    Busse Convenience kits containing swab/swabstick products manufactured by Professional Disposables International have been recalled due to uncertainty about the adequacy of manufacturing test method validation.

    Product
    SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1157-2022·2022-06-08

    I.V. Start Kit Recall Due to Uncertain Manufacturing Process Validation

    Busse Hospital Disposables is recalling I.V. Start Kit (Catalog 8172) due to inadequate validation of manufacturing processes for the included swab drug products. The recall affects 4,218 units distributed nationwide.

    Product
    I.V. Start Kit Catalog 8172
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1201-2022·2022-06-08

    Swab drug products recalled due to inadequate test method validation

    Busse Hospital Disposables is recalling convenience kits containing swab drug products manufactured by Professional Disposables International due to uncertainty about the adequacy of test methods used in manufacturing.

    Product
    Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1198-2022·2022-06-08

    Busse Convenience Kits Recalled Due to Manufacturing Test Validation Issue

    Busse Hospital Disposables is recalling Busse Convenience kits containing swab/swabstick drug products due to uncertainty about the adequacy of manufacturing test method validation.

    Product
    SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1163-2022·2022-06-08

    Busse Hospital Swab Products Recalled for Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Busse Convenience kits containing swab products due to uncertainty about manufacturing test method validation. No illnesses or injuries have been reported.

    Product
    MBB Tray Catalog Number: 9882
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1181-2022·2022-06-08

    Medical swab insertion tray recalled due to manufacturing validation uncertainty

    Busse Hospital Disposables recalls swab insertion trays due to uncertainty about manufacturing test method validation. The Class II recall affects products nationwide.

    Product
    SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1149-2022·2022-06-08

    Cervical Tray Catalog 1089 Recalled for Manufacturing Test Method Validation

    Busse Hospital Disposables, Inc. is recalling Cervical Tray Catalog 1089 convenience kits due to uncertainty regarding adequate validation of manufacturing test methods. No illnesses or injuries have been reported.

    Product
    Cervical Tray Catalog 1089
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1183-2022·2022-06-08

    Busse Hospital Swab Products Recalled for Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling swab and swabstick drug products due to uncertainty about whether manufacturing test methods were adequately validated. No illnesses or injuries have been reported.

    Product
    SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1177-2022·2022-06-08

    Busse Convenience Kits with Swabs Recalled Due to Manufacturing Validation Uncertainty

    Busse Convenience kits containing swab/swabstick drug products are recalled due to uncertainty about whether test methods used to validate manufacturing were adequately validated. Distributed nationwide.

    Product
    Bone Marrow Biopsy Tray Catalog Number: 8917R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1168-2022·2022-06-08

    Cervical Tray Recalled for Manufacturing Test Method Validation Uncertainty

    Busse Hospital Disposables is recalling Cervical Tray Catalog Number 3765R2 units containing swab products due to uncertainty about the adequacy of manufacturing test method validation. Lot Numbers 2031213S and 2130221S are affected.

    Product
    Cervical Tray Catalog Number: 3765R2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1151-2022·2022-06-08

    Busse Hospital Epidural Trays Recalled for Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Single Shot Epidural Trays due to uncertainty about whether manufacturing test methods were adequately validated. No illnesses or injuries have been reported.

    Product
    Single Shot Epidural Tray Catalog 1165
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1224-2022·2022-06-08

    Medical Device Patient Interface Recalled Due to Software Anomaly

    Medtronic is recalling the NIM Vital Patient Interface 4.0 due to a software anomaly identified in the device. The recall affects 29 units distributed worldwide, including in the US and France.

    Product
    NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1153-2022·2022-06-08

    Swab Drug Products Recalled for Manufacturing Test Method Validation Uncertainty

    Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International (PDI) are being recalled due to uncertainty about the adequacy of test method validation used in manufacturing.

    Product
    Epidural Tray Catalog 1307
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1146-2022·2022-06-08

    FDA recalls APD Drain Manifold units lacking regulatory clearance

    Baxter Healthcare is recalling 180 APD Drain Manifold units distributed in nine US states because certain product codes lack FDA regulatory clearance. Patients using affected units should contact Baxter Healthcare immediately.

    Product
    APD Drain Manifold
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1194-2022·2022-06-08

    Busse Convenience Kits Recalled Due to Inadequate Manufacturing Test Validation

    Busse Hospital Disposables is recalling Convenience kits containing swab/swabstick drug products due to uncertainty about the validation of manufacturing test methods. The FDA classified this as a Class II recall.

    Product
    Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1223-2022·2022-06-08

    Medtronic NIM Vital Console 4.0 Surgical Nerve Monitoring Device Software Anomaly Recall

    Medtronic Xomed is recalling 18 units of the NIM Vital Console 4.0 surgical nerve monitoring device due to an identified software anomaly. Distribution was confirmed in Texas, Colorado, New Jersey, and France.

    Product
    NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
    Category
    Medical Device
    Distribution
    Distributed nationwide