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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11601–11625 of 13748

  • HighFDA (Devices)·Z-1219-2022·2022-06-08

    MEDLINE Polyurethane Bedside Cleaning Kits Recalled Due to Microbial Contamination

    MEDLINE is recalling certain lots of its Polyurethane Bedside Cleaning Kits due to confirmed microbial contamination on the foam sponge. The kits were distributed in the US and Panama.

    Product
    MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1205-2022·2022-06-08

    Proton Therapy System Delivers Incorrect Radiation Dose in First Layer

    The Proteus235 Proton Therapy System may deliver radiation to initial treatment fields with incorrect scanning magnet settings. The radiation field may be smaller than expected and may deliver higher dose than prescribed.

    Product
    Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
    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-1203-2022·2022-06-08

    FDA Recalls Pellet Insertion Trays Due to Validation Method Uncertainty

    Busse Hospital Disposables is recalling 3.2MM Pellet Insertion Trays due to inadequate validation of manufacturing test methods. The recall affects 150 units distributed nationwide.

    Product
    3.2MM Pellet Insertion Tray Catalog Number: B9743
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1171-2022·2022-06-08

    Busse Convenience Kits Recalled: Drug Swabs Face Manufacturing Validation Uncertainty

    Professional Disposables International's swab and swabstick drug products, sold in Busse Convenience kits, are recalled due to uncertainty about whether manufacturing validation test methods were adequate.

    Product
    Nerve Block Tray Catalog Number: 6796R3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1196-2022·2022-06-08

    Busse Hospital Disposables Recalls Convenience Kits with Swab Products

    Busse Hospital Disposables is recalling Convenience kits containing swab products due to uncertainty about manufacturing validation adequacy. The kits were distributed nationwide.

    Product
    Pellet Insertion Tray Catalog Number: B1654
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1160-2022·2022-06-08

    Nerve Block Tray Recalled Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Nerve Block Trays containing swab and swabstick products due to uncertainty about manufacturing test method validation. Affected lot numbers should be discontinued.

    Product
    Nerve Block Tray Catalog Number: 9342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1212-2022·2022-06-08

    Organ Preservation Device Recalled Due to Incomplete Weld Seal

    XVIVO Perfusion AB is recalling the XVIVO Organ Chamber REF 19020 due to an incomplete weld seal on the primary pouch that prevents sterility assurance. Approximately 80 devices were distributed in the U.S. and internationally.

    Product
    XVIVO Organ Chamber REF 19020
    Category
    Medical Device
    Distribution
    8 states
  • 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-1152-2022·2022-06-08

    Busse Single Shot Epidural Tray recalled for test method validation uncertainty

    Busse Hospital Disposables is recalling Single Shot Epidural Trays nationwide due to uncertainty about the adequacy of test method validation used to manufacture swab components. The FDA classified this as a Class II recall.

    Product
    Single Shot Epidural Tray Catalog 1292
    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-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-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-1209-2022·2022-06-08

    da Vinci Vessel Sealer May Fail to Adequately Seal Tissue

    Intuitive Surgical is recalling da Vinci Vessel Sealer instruments worldwide because placing excessive tissue in the instrument jaws can result in an insufficient seal. Surgeons should follow proper technique guidelines when using the device.

    Product
    VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
    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-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-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
  • HighFDA (Devices)·Z-1216-2022·2022-06-08

    Ratcheting Screwdriver Handle in Surgical Kit Unable to Meet Sterilization Requirements

    Tornier's Ratcheting Screwdriver Handle in the Aequalis Perform Reversed kit cannot meet sterilization requirements when sterilized per instructions in an Aesculap container. The company is recalling 1066 units distributed nationwide.

    Product
    Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1145-2022·2022-06-08

    Peritoneal Dialysis Extension Sets Recalled for Missing FDA Clearance

    Baxter Healthcare Corporation is recalling 3.65 m peritoneal dialysis extension sets from Lot H19G12025 that were distributed without FDA regulatory clearance. The devices were distributed in error and should not be used.

    Product
    3,65 m Extension Set with Luer-lock Connector
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1166-2022·2022-06-08

    FDA Recalls CVC Dressing Change Kit Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling CVC Dressing Change Kits nationwide due to uncertainty about test method validation during manufacturing. Affected swab products may not have been adequately validated for sterility and efficacy.

    Product
    CVC Dressing Change Kit Catalog Number: 2491R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1170-2022·2022-06-08

    Sterile Epidural Tray Recalled Due to Validation Uncertainty

    Busse Hospital Disposables is recalling Sterile Epidural Trays nationwide due to uncertainty about whether test method validation was adequate. No illnesses or injuries have been reported.

    Product
    Sterile Epidural Tray Catalog Number: 6259R2
    Category
    Medical Device
    Distribution
    Distributed nationwide