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 the agency’s own highest classification or reported deaths or serious injuries, 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

14901–14925 of 27471

  • HighFDA (Devices)·Z-0134-2020·2019-10-23

    ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk

    ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filters. The recall covers 19,350 units distributed nationwide and internationally.

    Product
    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0136-2020·2019-10-23

    ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk

    ICU Medical is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filters. The affected units were distributed nationwide and internationally.

    Product
    Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PRIMARY PLUMSET 15 Micron Filter in Sight Chamber, CLAVE Port, 0.2 Micron Filter, CLAVE Y-Site, PE Lined Light Resistant Tubing, Distal Microbore Tubing 272 cm / 15 mL.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0131-2020·2019-10-23

    ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk

    ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filter air vents.

    Product
    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0130-2020·2019-10-23

    ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk

    ICU Medical is recalling Sapphire Microbore Infusion Sets with inline filters because fluid may leak out of the air vents. The recall covers 45,900 units distributed nationwide and internationally.

    Product
    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set, Microbore, CLAVE Y-Site, 118 Inch. 1 unit per pouch; 50 pouches per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0138-2020·2019-10-23

    ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk

    ICU Medical is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filter air vents. The recall covers 6,400 units distributed in the U.S. and internationally.

    Product
    Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0139-2020·2019-10-23

    ICU Medical Recalls Plum Microbore Infusion Sets Due to Fluid Leakage Risk

    ICU Medical Inc is recalling 521 units of Plum Microbore Infusion Sets because air vents on inline filters may leak fluid. The recall covers nationwide and international distribution.

    Product
    Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set, 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0127-2020·2019-10-23

    ICU Medical Recalls Plum Microbore Infusion Sets Due to Fluid Leakage

    ICU Medical Inc is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filter air vents.

    Product
    Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock, 104 Inch. 1 unit per pouch; 50…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0146-2020·2019-10-23

    ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk

    ICU Medical Inc is recalling Sapphire Microbore Infusion Sets with Inline Filters due to a potential for fluid leakage out of air vents.

    Product
    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case. Not distributed in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0122-2020·2019-10-23

    Medtronic Euphoria Balloon Catheters Recalled for Stylette Removal Difficulties

    Medtronic is recalling Euphoria Rapid Exchange Balloon Dilatation Catheters because a slightly higher diameter stylette causes removal difficulties.

    Product
    Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0143-2020·2019-10-23

    ICU Medical Recalls Sapphire Microbore Infusion Sets Due to Leakage Risk

    ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filter air vents. The product was distributed in the U.S. and internationally.

    Product
    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case . Not distributed in the U.S.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0125-2020·2019-10-23

    OrthoPediatrics Recalls Adolescent Attachment Bolts Due to Interference Risk

    OrthoPediatrics Corp is recalling 211 units of Adolescent attachment bolts used with the Pediatric Nailing Platform. The recall is due to potential interference between the bolt and nail, which may delay surgical procedures.

    Product
    OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the intramedullary fixation rod) Part number: 01-1503-0032
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0147-2020·2019-10-23

    ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk

    ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filters. The recall covers units distributed nationwide and internationally.

    Product
    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0135-2020·2019-10-23

    ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk

    ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filters. The recall covers 4,600 units distributed nationwide and internationally.

    Product
    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0137-2020·2019-10-23

    ICU Medical Recalls Plum Microbore Infusion Sets Due to Fluid Leakage Risk

    ICU Medical Inc is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filters. The affected units were distributed nationwide and internationally.

    Product
    Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0145-2020·2019-10-23

    ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk

    ICU Medical Inc is recalling 7,920 units of Plum Microbore Infusion Sets because fluid may leak from the inline filters.

    Product
    Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, 107 Inch. 1 unit per pouch; 48 pouches per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0148-2020·2019-10-23

    Siemens Atellica CH 930 Analyzer Recalled for Erroneous Hemolysis and Lipemia Indices

    Siemens Healthcare Diagnostics is recalling 1,125 Atellica CH 930 Analyzers worldwide due to software errors that may produce incorrect hemolysis and lipemia indices.

    Product
    Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0151-2020·2019-10-23

    Xodus Medical Recalls Cautery Tip Cleaners Due to Sterile Barrier Concerns

    Xodus Medical Inc is recalling 255,000 Cautery Tip Cleaners because the sterile barrier of some devices may have been affected.

    Product
    Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0150-2020·2019-10-23

    Xodus Medical Recalls Electrosurgical Tip Cleaners Due to Sterile Barrier Concerns

    Xodus Medical Inc is recalling 460,000 Electrosurgical Tip Cleaners because the sterile barrier of some devices may have been affected.

    Product
    Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessory
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0159-2020·2019-10-23

    Olympus Berkeley Disposa-Filter Recall Due to Weld Defect

    Olympus is recalling Berkeley Disposa-Filters used with the VC-10 Vacuum Curettage System because an ultrasonic weld defect may cause the housing to separate.

    Product
    Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0118-2020·2019-10-16

    TriMed Dorsal Wrist Hook Plate Recalled for Structural Integrity Issues

    TriMed Inc. is recalling 5 Dorsal Wrist Hook Plates due to unqualified design modifications that may compromise structural integrity.

    Product
    TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonsterile, Single Use Only, Rx. The firm name on the label is TriMed, Santa Clarita, CA.
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0074-2020·2019-10-16

    BD FACSLyric Flow Cytometers Recalled for Potential False High Counts

    Becton, Dickinson and Company is recalling 22 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with BD Trucount Tubes.

    Product
    BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD Trucount Tubes
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-0049-2020·2019-10-16

    Becton Dickinson Recalls CareFusion MaxPlus Clear Needleless Connectors

    Becton Dickinson is recalling 115,200 CareFusion MaxPlus Clear Needleless Connectors because the valve may fail to close, posing risks of blood loss and air embolism.

    Product
    CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy Cat. No. MP1000-C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0064-2020·2019-10-16

    Conformis Recalls iTotal Hip Replacement Stems Due to Packaging Error

    Conformis, Inc. is recalling two iTotal Hip Replacement femoral stems because sizes 13 and 15 were packed in each other's packaging.

    Product
    iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0094-2020·2019-10-16

    Centurion Medical CVC Bundle Recall Due to Fluid Droplet Risk

    Centurion Medical is recalling CVC Bundle VanTex kits because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.

    Product
    CVC BUNDLE VANTEX 7F, 3L, 20CM ECVC6065
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2020·2019-10-16

    Roche Tina-quant sTfR Assay Recalled for Rheumatoid Factor Interference

    Roche Diagnostics is recalling Tina-quant sTfR assays due to updated claims regarding rheumatoid factor interference.

    Product
    cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122
    Category
    Medical Device
    Distribution
    Distributed nationwide