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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15351–15375 of 27471

  • 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
  • HighFDA (Devices)·Z-2350-2019·2019-08-28

    Siemens ACUSON NX2 Ultrasound Systems Recalled for Acoustic Output Power Defect

    Siemens is recalling ACUSON NX2 ultrasound systems because internal testing found transducers may exceed defined acoustic output power values.

    Product
    ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2301-2019·2019-08-28

    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) 56 Units Blood Collection Tubes, Catalog Number 367960
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2299-2019·2019-08-28

    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 the IL GEM 4000 instrument.

    Product
    BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2306-2019·2019-08-28

    BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results

    Becton Dickinson is recalling BD Vacutainer PST Blood Collection Tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2345-2019·2019-08-28

    Siemens MAGNETOM Prisma MRI Devices Recalled for Quench Venting Port Issue

    Siemens is recalling 17 MAGNETOM Prisma MRI devices due to a potential open port in the quench venting system when using the optional horizontal outlet.

    Product
    MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-2297-2019·2019-08-28

    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) 56 USP Units Blood Collection Tubes, Catalog Number 366667
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2352-2019·2019-08-28

    Siemens ACUSON NX3 Ultrasound Systems Recalled for Acoustic Output Power Defect

    Siemens is recalling 1,384 ACUSON NX3 diagnostic ultrasound systems worldwide because internal testing found transducers may exceed defined acoustic output power values.

    Product
    ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004297 The ACUSON NX2 diagnostic ultrasound imaging systems are intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2348-2019·2019-08-28

    Thoratec HeartMate 3 LVAS Implant Kit Recalled for Outflow Graft Leaks

    Thoratec Corp. is recalling HeartMate 3 LVAS Implant Kits because an insufficiently seated C-Ring can cause the outflow graft to leak during implantation, rendering the device nonfunctional.

    Product
    Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2320-2019·2019-08-28

    Radiometer ABL90 FLEX Analyzer Recalled for Software Security Vulnerabilities

    Radiometer America Inc is recalling ABL90 FLEX Analyzers due to software security vulnerabilities that may cause device shutdowns or reboots, potentially delaying medical treatment.

    Product
    ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-2307-2019·2019-08-28

    BD Vacutainer Blood Collection Tubes Recalled for False COHb Results

    Becton Dickinson is recalling BD Vacutainer PST Gel and Lithium Heparin 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) 56 Units Blood Collection Tubes, Catalog Number 368056
    Category
    Medical Device
    Distribution
    Distributed nationwide