The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

25051–25075 of 50443

  • 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 (Food)·F-2061-2019·2019-08-28

    Green Water Recalls Multiple Herbal Tinctures and Teas Due to Salmonella Risk

    Green Water, LLC is recalling several herbal tinctures and teas due to potential Salmonella contamination. The products were distributed nationwide.

    Product
    Taspen s Organics, Breathe Easy Herbal Tincture, Net wt 1 ounce, 2 ounce, 4 ounce
    Category
    Food
    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 (Food)·F-2082-2019·2019-08-28

    Mariposa Farms Basil Recalled Due to Possible Cyclospora Link

    Mariposa Farms is recalling basil due to a possible link to a cyclospora illness outbreak. Consumers should check for Lot # 6985.

    Product
    Mariposa Farms Basil, Net Wt. 0.75 OZ, in plastic clamshell containers for retail sale. Mariposa Farms, Inc. Grinnell, IA
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2081-2019·2019-08-28

    Rock Garden Fresh Basil Recalled for Potential Cyclospora Contamination

    Herbs Unlimited is recalling Rock Garden brand fresh basil due to potential Cyclospora contamination. The product was distributed to Publix and other distributors.

    Product
    Fresh basil with Rock Garden brand label. Basil was packed in 1 lb. plastic bags and in 0.75 oz. clear plastic clamshell containers.
    Category
    Food
    Distribution
    0 states
  • 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 (Food)·F-2057-2019·2019-08-28

    Keto Farms Strawberry Gouda Snack Mix Recalled for Undeclared Coconut

    Keto Farms is recalling Strawberry Gouda snack mix because an inspection found undeclared coconut on the label.

    Product
    Keto Farms Keto Snack Mix - Strawberry Gouda; Fruit & Cheese Mix with Sprouted Pecans & Almonds; Net Wt. 95 g (3.34 oz.) Ingredients: Gouda Cheese (Pasteurized Milk, Cheese Culture, Salt, Enzymes), Sprouted Organic Pecans, Sprouted Transitional Almonds, Strawberries, MCT…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·19V627000·2019-08-28

    Toyota and Pontiac Recall Vehicles for Front Passenger Air Bag Defect

    Toyota and GM are recalling specific Corolla, Corolla Matrix, and Pontiac Vibe vehicles because the front passenger air bag may not inflate properly in high temperatures.

    Product
    PONTIAC — PONTIAC, TOYOTA VIBE, COROLLA, COROLLA MATRIX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2062-2019·2019-08-28

    Green Water Recalls Multiple Herbal Tinctures and Teas for Salmonella Risk

    Green Water, LLC is recalling several herbal tinctures and teas due to potential Salmonella contamination. The products were distributed nationwide.

    Product
    Taspen s Organics,Digest Ease Herbal Tincture, Net wt 1 ounce, 2 ounce, 4 ounce
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2063-2019·2019-08-28

    Green Water Recalls Multiple Herbal Tinctures and Teas Due to Salmonella Risk

    Green Water, LLC is recalling several herbal tinctures and teas due to potential Salmonella contamination. The products were distributed nationwide.

    Product
    Taspen s Organics,Happy Momma Herbal Tincture, Net wt 1 ounce, 2 ounce, 4 ounce
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2059-2019·2019-08-28

    Keto Farms Recalls Raspberry Gouda Snack Mix for Undeclared Coconut

    Keto Farms LLC is recalling its Raspberry Gouda Fruit & Cheese Mix because an inspection found that coconut, a declared allergen, was missing from the label.

    Product
    Keto Farms Keto Snack Mix - Raspberry Gouda Fruit & Cheese Mix with Sprouted Almonds & Walnuts; Net Wt. 95 g (3.34 oz. Ingredients: Gouda Cheese (Pasteurized Milk, Cheese Culture, Salt, Enzymes), Sprouted Organic Walnuts, Sprouted Transitional Almonds, Raspberries…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2078-2019·2019-08-28

    Hannaford Quiche Recalled for Missing Allergen Labeling

    Meninno Brothers Gourmet Foods is recalling Hannaford brand quiche because the label lacks an ingredient or allergen statement.

    Product
    Hannaford brand 20 oz. traditional quiche w/tomatoes, cheese and basil in flexible plastic with round top and bottom.
    Category
    Food
    Distribution
    4 states
  • 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