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.

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15326–15350 of 27500

  • HighFDA (Devices)·Z-2409-2019·2019-09-04

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta is recalling 49 Monaco Radiation Treatment Planning Systems because software errors display and export incorrect anatomy and beam shift directions.

    Product
    Monaco Radiation Treatment Planning System (RTP) System
    Category
    Medical Device
    Distribution
    2 states
  • CriticalFDA (Devices)·Z-2226-2019·2019-08-28

    Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons

    Edwards Lifesciences is recalling SAPIEN 3 Ultra Transcatheter Heart Valve Systems due to reports of burst balloons that caused difficulty retrieving the device during procedures.

    Product
    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-2227-2019·2019-08-28

    Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons

    Edwards Lifesciences is recalling SAPIEN 3 Ultra Transcatheter Heart Valve Systems because burst balloons can make it difficult to remove the device from patients.

    Product
    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-2295-2019·2019-08-28

    Arcos Burn Navigator H2 Recalled for Battery Fire Risk

    Arcos, Inc. is recalling 28 Burn Navigator H2 units because their battery packs may heat up abnormally and ignite in rare instances.

    Product
    Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 Catalog 1125, Burn Navigator¿ H2 Transport Package Burn Navigator User Manual Manual-1120 Burn Navigator User's Manual, Rev. F Battery: Panasonic Model CF-H2 Part Number CMP-1523
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2224-2019·2019-08-28

    Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons

    Edwards Lifesciences is recalling 362 units of the SAPIEN 3 Ultra Transcatheter Heart Valve System due to reports of burst balloons that complicate device retrieval.

    Product
    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-2225-2019·2019-08-28

    Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons

    Edwards Lifesciences is recalling SAPIEN 3 Ultra Transcatheter Heart Valve Systems due to reports of burst balloons that caused significant difficulty retrieving the device during procedures.

    Product
    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2308-2019·2019-08-28

    BD Vacutainer Blood Collection Tubes Recalled for False COHb Results

    Becton Dickinson is recalling BD Vacutainer LH blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.

    Product
    BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2341-2019·2019-08-28

    Siemens N Cuvette Segments Recalled for Falsely Elevated Albumin Results

    Siemens Healthcare Diagnostics is recalling N Cuvette Segments for the BN ProSpec System because they may produce falsely elevated albumin results.

    Product
    N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2310-2019·2019-08-28

    BD Vacutainer Lithium Heparin Tubes Recalled for False COHb Results

    Becton Dickinson is recalling BD Vacutainer LH blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2349-2019·2019-08-28

    Thoratec Heartmate 3 Sealed Outflow Graft Recall for Leak Risk

    Thoratec Corp. is recalling 149 Heartmate 3 Sealed Outflow Graft units because the C-Ring may not seat properly, causing leaks during implantation.

    Product
    Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2294-2019·2019-08-28

    TiSport Recalls TiLite Wheelchair Anti-Tip Tubes for Tipping Risk

    TiSport is recalling 1,452 TiLite wheelchairs because the anti-tip tubes may fail, allowing the chair to tip backwards.

    Product
    TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and AERO R, a component of the TiLite wheelchair (anti-tip extension for manual wheelchairs). Product Usage: The affected component is part of a manual wheelchair to provide mobility to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2290-2019·2019-08-28

    Siemens IMMULITE 2000 Progesterone Test Recalled for Potential Low Results

    Siemens is recalling IMMULITE 2000 Progesterone tests because some samples may produce falsely low results, potentially leading to unnecessary medication.

    Product
    IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2296-2019·2019-08-28

    BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results

    Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.

    Product
    BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2343-2019·2019-08-28

    Siemens MAGNETOM Skyra MRI Devices Recalled for Quench Venting System Defect

    Siemens is recalling 44 MAGNETOM Skyra MRI devices due to a potential open port in the quench venting system when using an optional horizontal outlet.

    Product
    MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-2319-2019·2019-08-28

    Qiagen QIAsymphony SP Software 5.0.3 Recalled for Barcode Assignment Error

    Qiagen is recalling QIAsymphony SP software version 5.0.3 because it incorrectly assigns 2D barcode eluate IDs to samples, which could lead to incorrect patient reporting.

    Product
    QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids-IVD) Model Number: 9001297 Product Usage: The QIAsymphony SP instrument is designed to perform automated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2289-2019·2019-08-28

    Siemens IMMULITE 1000 Progesterone Test Recall for Low Results

    Siemens is recalling IMMULITE 1000 Progesterone tests because they may produce falsely low results, potentially leading to unnecessary progesterone supplementation.

    Product
    IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2293-2019·2019-08-28

    DeRoyal Enteral Safe Feeding Tubes Recalled for Connector Detachment

    DeRoyal Industries is recalling specific polyurethane feeding tubes because the connector may detach from the tube.

    Product
    DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF 54-2465R, 6.5 FR x 24" Polyurethane c) REF 54-2480R, 8 FR x 24" Polyurethane d) REF 54-3680R, 8 FR x 36" Polyurethane Product Usage: Feeding tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2292-2019·2019-08-28

    Luminex Aries M1 Barcode Scanner Recall for Sample Mismatch Risk

    Luminex is recalling Aries M1 barcode scanners due to incorrect control boards that could cause patient sample mismatches or duplicate results.

    Product
    Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2298-2019·2019-08-28

    BD Vacutainer Lithium Heparin Tubes Recalled for False COHb Results

    Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.

    Product
    BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2309-2019·2019-08-28

    BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results

    Becton Dickinson is recalling BD Vacutainer LH blood collection tubes because they can cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2305-2019·2019-08-28

    BD Vacutainer Blood Collection Tubes Recalled for False COHb Results

    Becton Dickinson is recalling specific blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes, Catalog Number 367964
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2304-2019·2019-08-28

    BD Vacutainer Blood Collection Tubes Recalled for False COHb Results

    Becton Dickinson is recalling specific blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catalog Number 367963
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2303-2019·2019-08-28

    BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results

    Becton Dickinson is recalling specific blood collection tubes because they may cause falsely elevated carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tubes, Catalog Number 367962
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2353-2019·2019-08-28

    Siemens ACUSON NX3 Ultrasound Systems Recalled for Acoustic Output Power Defect

    Siemens is recalling ACUSON NX3 Elite ultrasound systems because internal testing found transducers may exceed defined acoustic output power values.

    Product
    ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004303 The ACUSON NX2 diagnostic ultrasound imaging systems are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2302-2019·2019-08-28

    BD Vacutainer Blood Collection Tubes Recalled for False COHb Results

    Becton Dickinson is recalling specific blood collection tubes because they can cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood Collection Tubes, Catalog Number 367961
    Category
    Medical Device
    Distribution
    Distributed nationwide