The Recall Desk

Archive

September 2020 recalls

631 recalls were announced in September 2020.

What the numbers show

Critical
56
Severe
123
High
285
Moderate
154
Low
13

Of the 631 recalls this month scored against our rubric, 9% are Critical, 19% are Severe.

101–200 of 631

  • CriticalFDA (Drugs)·D-1619-2020·2020-09-23

    RLC Labs Recalls Subpotent Nature Throid Thyroid Medication

    RLC Labs Inc. is recalling Nature Throid 1.5 Grain thyroid medication because FDA analysis found the product to be subpotent.

    Product
    Nature Throid, 1.5 Grain (97.5 mg) Thyroid USP [Liothyronine (T3) 13.5 mcg, Levothyroxine (T4) 57 mcg], packaged in a) 30-count bottles (NDC 64727-3305-4), b) 60-count bottles (NDC 64727-3305-5), c) 90-count bottles (NDC 64727-3305-6), and 100-count bottles (NDC 64727-3305-1), R
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1438-2020·2020-09-23

    Wawona Fresh Peaches Recalled Due to Salmonella Enteritidis Outbreak Link

    Wawona Packing Co LLC is recalling fresh peaches because trace-back information links them to a Salmonella Enteritidis outbreak.

    Product
    Fresh peaches - sold loose/bulk and Bagged fresh peaches, 2 lbs. plastic pouch under brand names of: Wawona- UPC 033383322001 Wawona Organic- UPC 849315000400 Prima - UPC 766342325903, Walmart Organic Marketside - UPC 766342325903, Kroger - UPC 011110181749, Wegmans -
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1511-2020·2020-09-23

    Wegmans Mini Fruit Topped Shortcake Recalled for Salmonella Risk

    Wegmans is recalling Mini Fruit Topped Shortcakes because raw peaches may be contaminated with Salmonella Enteritidis.

    Product
    Wegmans Mini Fruit Topped Shortcake, 5oz; UPC 7789038790
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-1606-2020·2020-09-23

    RLC Labs Recalls WP Thyroid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling WP Thyroid tablets due to Current Good Manufacturing Practice (CGMP) deviations. The products were manufactured under conditions found to be subpotent.

    Product
    WP Thyroid, Westhroid Pure, Thyroid USP, [liothyronine (T3) 2.25 mcg and levothyroxine (T4) 9.5 mcg], 1/4 Grain (16.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-5450-4; b) 60-count bottles, NDC 64727-5450-5; c) 90-count bottles, NDC 64727-5450-6; d) 100-count bottle
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1607-2020·2020-09-23

    RLC Labs Recalls WP Thyroid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling WP Thyroid tablets because they were manufactured under conditions found to be subpotent.

    Product
    WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5550-2 ; b) 30 Tablets, NDC 64727-5550-4; c) 60 Tablets, NDC 64727-5550-5; d) 90 Tablets, NDC 64727-5550-6; e) 100 Tablets, NDC 64727-5550-1; Rx only, Manufactured by: RLC Labs Pho
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1579-2020·2020-09-23

    Scent Theory Hand Sanitizer Recalled for Methanol Contamination

    Scent Theory KEEP IT CLEAN hand sanitizer is being recalled because it was manufactured in a facility where methanol contamination was found.

    Product
    scent theory KEEP IT CLEAN, pure clean,(Ethyl Alcohol 70%), 16.9 FL OZ/500 mL, Distributed by Scent Theory Products, LLC New York, NY 10018, Made in Mexico, UPC 8 40038 21434 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1581-2020·2020-09-23

    Born Basic Hand Sanitizer Recalled for Methanol Contamination

    The FDA is recalling Born Basic Anti-Bac Hand Sanitizer because it contained methanol and had lower ethanol levels than labeled. The recall includes other products from the same manufacturing facility.

    Product
    BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), packaged as a) 9.5 FL OZ (280 mL) bottle, UPC 8 40038 21462 4: b) 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3; and c) 34 FL OZ (1L) bottle, UPC 8 40038 21447 1; Made in Mexico; Distributed by Scent Theory
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1600-2020·2020-09-23

    RLC Labs Recalls Nature-Throid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling Nature-Throid tablets due to Current Good Manufacturing Practice (CGMP) deviations. The products were manufactured under conditions found to be subpotent.

    Product
    Nature-Throid, Thyroid USP [liothyronine (T3) 13.5 mcg and levothyroxine (T4) 57 mcg], 1.5 Grain (97.5 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3305-4; b) 60-count bottles, NDC 64727-3305-5; c) 90-count bottles, NDC 64727-3305-6; d) 100-count bottles, NDC 64727-33
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1577-2020·2020-09-23

    Broncolin HERBACIL Hand Sanitizer Recalled for Methanol Contamination Risk

    Broncolin is recalling HERBACIL Antiseptic Hand Sanitizer because it was manufactured in the same facility as a product found to contain methanol.

    Product
    HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as a) 4.22 fl. oz. (125ml) bottle, UPC 7 14706 91368 6; b) 8.4 fl. oz. (250 ml) bottle, UPC 714706 91367 9; c) 16.9 fl. oz. (500 ml) bottle, UPC 7 14706 91366 2; and d) 33.8 fl. oz. (1 Liter) bottle, UPC 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1611-2020·2020-09-23

    RLC Labs Recalls WP Thyroid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling WP Thyroid tablets because they were manufactured under conditions associated with subpotent products.

    Product
    WP Thyroid, Westhroid Pure, 1.5 Grain (97.5 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5850-2 ; b) 30 Tablets, NDC 64727-5850-4; c) 60 Tablets, NDC 64727-5850-5; d) 90 Tablets, NDC 64727-5850-6; e) 100 Tablets, NDC 64727-5850-1; Rx only, Manufactured by: RLC Labs P
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1616-2020·2020-09-23

    RLC Labs Recalls Subpotent Nature Throid Thyroid Medication

    RLC Labs Inc. is recalling Nature Throid thyroid medication because FDA analysis found the product to be subpotent.

    Product
    Nature Throid, 3/4 Grain (48.75 mg) Thyroid USP [Liothyronine (T3) 6.75 mcg, Levothyroxine (T4) 28.5 mcg], packaged in a) 100-count bottles (NDC 64727-3302-1) and b) 1000-count bottles (NDC 64727-3302-2), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1580-2020·2020-09-23

    Scent Theory Hand Sanitizer Recalled for Methanol Contamination

    Scent Theory KEEP CLEAN Moisturizing Hand Sanitizer is being recalled because it contained methanol and fell below the labeled ethanol content.

    Product
    scent theory KEEP CLEAN Moisturizing Hand Sanitizer, 70% alcohol (Ethyl Alcohol 70%), 16.9 FL OZ/500 mL bottle, Distributed by Scent Theory Products, LLC New York, NY 10018. Made in Mexico, UPC 8 40038 21434 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2975-2020·2020-09-23

    Inpeco Aptio Automation Systems Recalled for Potential Sample ID Mis-association

    Inpeco S.A. is recalling Aptio Automation systems with Sysmex Interface Modules because a firmware defect may mis-associate sample IDs, leading to incorrect or delayed clinical chemistry results.

    Product
    Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analyti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1582-2020·2020-09-23

    LUX EOI Hand Sanitizing Gel Recalled for Methanol Contamination

    Real Clean Distribuciones SA de CV is recalling LUX EOI Hand Sanitizing Gel because it contained methanol and was below the label claim for ethanol content.

    Product
    LUX EOI Hand Sanitizing Gel, (Ethyl Alcohol 70%), (16.9 FL OZ) 500mL bottle, Distributed by: Procurement Services, LLC Nashville, TN 37215, Product of Mexico. NDC 74882-007-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1514-2020·2020-09-23

    Wegmans Peach Shortcake Recalled Due to Salmonella Contamination Risk

    Wegmans is recalling two varieties of peach shortcake because raw peaches may be contaminated with Salmonella Enteritidis.

    Product
    Wegmans Peach Shortcake Slice; 7oz; UPC 7789051241 and Wegmans 1 Layer Peach Shortcake; 26oz; UPC: 7789051239
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-1614-2020·2020-09-23

    RLC Labs Recalls Subpotent WP Thyroid and Westhroid Pure Prescription Medications

    RLC Labs Inc. is recalling specific lots of WP Thyroid and Westhroid Pure because FDA analysis found the products to be subpotent.

    Product
    WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine (T4) 19 mcg], packaged in a) 30-count bottles (NDC 64727-5550-4), b) 90-count bottles (NDC 64727-5550-6), c) 100-count bottles (NDC 64727-5550-1), Rx only, Manufactured by: RLC L
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1618-2020·2020-09-23

    RLC Labs Recalls Subpotent Nature Throid Thyroid Medication

    RLC Labs Inc. is recalling Nature Throid 2 Grain thyroid medication because FDA analysis found the product to be subpotent.

    Product
    Nature Throid, 2 Grain (130 mg) Thyroid USP [Liothyronine (T3) 18 mcg, Levothyroxine (T4) 76 mcg], packaged in a) 30-count bottles (NDC 64727-3308-4) and b)100-count bottles (NDC 64727-3308-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1617-2020·2020-09-23

    RLC Labs Recalls Subpotent Nature Throid Thyroid Medication

    RLC Labs Inc. is recalling Nature Throid 1.25 Grain thyroid medication because FDA analysis found the product to be subpotent.

    Product
    Nature Throid, 1.25 Grain (81.25 mg) Thyroid USP [Liothyronine (T3) 11.25 mcg, Levothyroxine (T4) 47.5 mcg], 100-count bottles, Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024, NDC 64727-3303-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·20E069000·2020-09-23

    Ford Recalls Replacement Brake Pedal Brackets Due to Fracture Risk

    Ford is recalling certain replacement brake pedal brackets that may fracture during sudden stopping, potentially affecting braking ability and increasing crash risk.

    Product
    SERVICE BRAKES, HYDRAULIC:PEDALS AND LINKAGES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V573000·2020-09-23

    Ford Recalls 2020 Mustangs Due to Brake Pedal Bracket Fracture Risk

    Ford is recalling 2020 Mustangs with automatic transmissions because the brake pedal bracket may fracture, potentially affecting braking ability and increasing crash risk.

    Product
    FORD — FORD MUSTANG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20E064000·2020-09-23

    Volkswagen Master Cylinders Recalled for Brake Fluid Leak Risk

    Tenneco is recalling aftermarket master cylinders for 2004-2018 Jetta and 2012-2019 Beetle vehicles due to a seal defect that may cause brake fluid leaks and reduced braking ability.

    Product
    VOLKSWAGEN — VOLKSWAGEN BEETLE, JETTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1597-2020·2020-09-23

    RLC Labs Recalls Nature-Throid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling Nature-Throid tablets nationwide because they were manufactured under conditions found to be subpotent.

    Product
    Nature-Throid, Thyroid USP [liothyronine (T3) 6.75 mcg and levothyroxine (T4) 28.5 mcg], 3/4 Grain (48.75 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3302-4; b) 60-count bottles, NDC 64727-3302-5; c) 90-count bottles, NDC 64727-3302-6; d) 100-count bottles, NDC 64727-
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1601-2020·2020-09-23

    RLC Labs Recalls Nature-Throid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling Nature-Throid tablets due to Current Good Manufacturing Practice (CGMP) deviations. The products were manufactured under conditions found to be subpotent.

    Product
    Nature-Throid, Thyroid USP [liothyronine (T3) 15.75 mcg and levothyroxine (T4) 66.5 mcg], 1.75 Grain (113.75 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3307-4; b) 60-count bottles, NDC 64727-3307-5; c) 90-count bottles, NDC 64727-3307-6; d) 100-count bottles, NDC 64
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1608-2020·2020-09-23

    RLC Labs Recalls WP Thyroid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling WP Thyroid tablets because they were manufactured under conditions associated with subpotent products.

    Product
    WP Thyroid, Westhroid Pure, 3/4 Grain (48.75 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-5650-2 ; b) 30 Tablets, NDC 64727-5650-4; c) 60 Tablets, NDC 64727-5650-5; d) 90 Tablets, NDC 64727-5650-6; e) 100 Tablets, NDC 64727-5650-1; Rx only, Manufactured by: RLC Labs
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2965-2020·2020-09-23

    Randox Ammonia Reagent Recall Due to Positive Bias in Patient Samples

    Randox Laboratories is recalling 143 kits of AM1015 Ammonia reagents due to a positive bias of up to 140 µmol/L observed in patient samples.

    Product
    AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
    Category
    Medical Device
    Distribution
    3 states
  • SevereNHTSA·20V576000·2020-09-23

    Ford Recalls 2019 F-250 and F-350 Trucks for Axle Weld Defect

    Ford is recalling 2019 F-250 and F-350 trucks because a front axle weld may be improper, increasing crash risk. Dealers will inspect and replace axles if needed.

    Product
    FORD — FORD redundant F-250, redundant F-350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1603-2020·2020-09-23

    RLC Labs Recalls Nature-Throid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling Nature-Throid tablets due to Current Good Manufacturing Practice (CGMP) deviations. The product was manufactured under conditions associated with subpotency.

    Product
    Nature-Throid, Thyroid USP [liothyronine (T3) 20.25 mcg and levothyroxine (T4) 85.5 mcg], 2.25 Grain (146.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3309-4; b) 60-count bottles, NDC 64727-3309-5; c) 90-count bottles, NDC 64727-3309-6; d) 100-count bottles, NDC 647
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1524-2020·2020-09-23

    Blue Apron Recalls Smoked Gouda Meal Kits Due to Salmonella Risk

    Blue Apron is recalling Smoked Gouda & Onion Burgers meal kits delivered the week of July 27, 2020, because the onions may be contaminated with Salmonella.

    Product
    Smoked Gouda & Onion Burgers with Corn on the Cob meal kits containing onions delivered the week of July 27, 2020.
    Category
    Food
    Distribution
    37 states
  • HighFDA (Devices)·Z-2972-2020·2020-09-23

    Imactis Patient Fiducial Recalled Due to Component Separation Risk

    Imactis is recalling Patient Fiducial components because they may separate from the body, potentially causing navigation inaccuracies or improper needle trajectory.

    Product
    Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1509-2020·2020-09-23

    Fresco Foods Recalls Jackfruit Bowls Due to Undeclared Fish Allergen

    Fresco Foods is recalling Ancient Grain Jackfruit Bowls because the packaging failed to disclose the presence of anchovies, a fish allergen.

    Product
    Ancient Grain Jackfruit Bowl with Chickpeas & Edamame in a Thai Coconut Sauce, Eat Fresco, Keep Refrigerated, NET WT 14oz (397gr), Cook Thoroughly
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2973-2020·2020-09-23

    Inpeco FlexLab Laboratory Automation System Recalled for Sample ID Errors

    Inpeco S.A. is recalling FlexLab laboratory automation systems because firmware issues may cause sample ID mis-association, leading to incorrect or delayed test results.

    Product
    FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Laboratory Automation system - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Pos
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2956-2020·2020-09-23

    Novarad Recalls NovaPACS Diagnostic Viewer Software Due to Image Placement Error

    Novarad Corporation is recalling NovaPACS Diagnostic Viewer software because the cross-localization feature may inaccurately place reference lines on asymmetrical images.

    Product
    NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display images and data from different modalities including CT, MR, US, CR/DX, NM, PT, and XA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V574000·2020-09-23

    Ford Recalls 2020 Expedition Vehicles for Seat Belt Sensor Defect

    Ford is recalling 2020 Expedition vehicles because the seat belt tension sensor may misclassify a child as an adult. This could cause the airbag to deploy in a crash, increasing injury risk.

    Product
    FORD — FORD EXPEDITION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V577000·2020-09-23

    2021 Airstream Basecamp Trailers Recalled for Incorrect Tire Placard Information

    Airstream is recalling certain 2021 Basecamp 16 trailers because the tire placard displays incorrect tire size and inflation pressure. If tires are inflated per the incorrect label, they could become dangerously underinflated, increasing crash risk.

    Product
    AIRSTREAM — AIRSTREAM BASECAMP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1439-2020·2020-09-23

    Peach Salsa Recalled Due to Potential Salmonella Contamination

    Russ Davis Wholesale, LLC is recalling Peach Salsa products due to potential Salmonella contamination. Consumers should discard the product or return it to the store of purchase.

    Product
    Peach Salsa, Keep Refrigerated packed in the following size containers and brands: 1. Crazy Fresh, Net Wt. 8 oz UPC 795631 820270; 2. quick & easy, Net Wt 8 oz UPC 795631 820270; 3. Not branded, clear sticker Net Wt 8 oz UPC 795631 820270; 4. Not branded, Net Wt
    Category
    Food
    Distribution
    9 states
  • HighCPSC·20190·2020-09-23

    Specialized Recalls Sirrus Bicycles with Alloy Cranks Due to Fall Hazards

    Specialized Bicycle Components is recalling approximately 36,000 Sirrus, Sirrus X, and Sirrus Sport bicycles in the U.S. because the alloy crank arms can disengage, posing fall and injury hazards.

    Product
    Sirrus, Sirrus X and Sirrus Sport Bicycles with alloy cranks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2978-2020·2020-09-23

    Life Technologies Recalls TaqPath RT-PCR COVID-19 Kit Software

    Life Technologies is recalling the TaqPath RT-PCR COVID-19 Kit due to software issues that may cause invalid, inconclusive, or false test results.

    Product
    The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens and
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2974-2020·2020-09-23

    Inpeco FlexLab 3.6 Automation Recalled for Potential Sample ID Mis-association

    Inpeco S.A. is recalling 8 FlexLab 3.6 Automation systems because firmware issues may cause sample ID mis-association, leading to incorrect or delayed clinical chemistry results.

    Product
    Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analyti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2960-2020·2020-09-23

    Terumo Ultrasonic Air Sensor Recall Due to Backwards Crimped Wire

    Terumo is recalling three Ultrasonic Air Sensors because a crimped wire was installed backwards, potentially causing false air bubble alarms during extracorporeal procedures.

    Product
    Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2970-2020·2020-09-23

    Siemens epoc BGEM Test Card Recalled for Inconsistent Glucose Results

    Siemens Healthcare Diagnostics Inc is recalling specific lots of epoc BGEM Test Cards due to sporadically inconsistent low glucose results that could delay diagnosis or cause unnecessary treatment.

    Product
    Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care SMN#/Model #: 10736382
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2964-2020·2020-09-23

    Cook Zenith Alpha Abdominal Endovascular Graft Recalled for Excess Glue

    Cook Inc. is recalling Zenith Alpha Abdominal Endovascular Grafts due to excess glue in the delivery system handle, which may prevent full deployment.

    Product
    Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1523-2020·2020-09-23

    Blue Apron Recalls Spicy Beef Meal Kits Due to Salmonella Risk

    Blue Apron is recalling Spicy Beef & Vegetables meal kits delivered the week of July 27, 2020, because the onions may be contaminated with Salmonella.

    Product
    Spicy Beef & Vegetables with Rice & Sesame Seeds meal kits containing onions delivered the week of July 27, 2020.
    Category
    Food
    Distribution
    37 states
  • HighNHTSA·20V575000·2020-09-23

    Ford Recalls 2020 Vehicles for Rearview Camera Electrical Defect

    Ford is recalling 620,246 2020 vehicles because a poor electrical connection may cause the rearview camera to display a blank or distorted image, increasing crash risk.

    Product
    FORD — FORD, LINCOLN F-150, RANGER, F-250 SD, F-350 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2953-2020·2020-09-23

    Integra LifeSciences Recalls 13 ft Handpiece Cables for Dermatome Sets

    Integra LifeSciences is recalling 74 units of 13 ft handpiece cables used in dermatome sets because the cables melt after sterilization.

    Product
    13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in h
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V578000·2020-09-23

    MCI Recalls 2019 D45 CRT LE Coaches Due to Seat Belt Defect

    Motor Coach Industries is recalling 2019 D45 CRT LE coaches because seat belt retractors in the last row may not function, increasing injury risk in collisions.

    Product
    MCI — MCI D45 CRT LE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2979-2020·2020-09-23

    Life Technologies Recalls TaqPath RT-PCR COVID-19 Kit Software

    Life Technologies is recalling the TaqPath RT-PCR COVID-19 Kit due to software issues that may cause invalid, inconclusive, or false test results.

    Product
    The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 (used with the QuantStudio Real-Time PCR platforms), includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Food)·F-1521-2020·2020-09-23

    Ponder Foods Recalls Sweet Chili Sauce for Undeclared Peanuts

    Ponder Foods is recalling Pretty Thai brand Sweet Chili Sauce because it may contain undeclared peanuts. The product was distributed in Texas.

    Product
    Pretty Thai brand Sweet Chili Sauce Net Wt 11.2 oz (317g) UPC 860043001224 packaged in a clear PET plastic bottle with a white label.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2952-2020·2020-09-23

    Longhorn PrimeStore Molecular Transport Medium Tubes Recalled for Cyanide Risk

    Longhorn Vaccines and Diagnostic is recalling PrimeStore Molecular Transport Medium tubes because the solution may produce cyanide gas when exposed to bleach.

    Product
    PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabilization, transportation, and inactivation of infectious unprocessed nasal washes, nasopharyngeal, oral/throat swabs* suspected of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·20192·2020-09-23

    Kobalt Cordless Electric Pole Saws Recalled for Laceration Hazard

    Kobalt 40-volt cordless electric pole saws are being recalled because the switch can fail, causing the saw to continue running and posing a laceration risk.

    Product
    Kobalt brand 40-volt Lithium Ion 8-inch Cordless Electric Pole Saws
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1525-2020·2020-09-23

    Blue Apron Meal Kits Recalled Due to Salmonella Contamination Risk

    Blue Apron is recalling meal kits delivered the week of July 27, 2020, because the onions included may be contaminated with Salmonella.

    Product
    Carmelized Onion & Gouda Burgers with Creamy Mustard Dressed Corn on the Cob meal kits containing onions delivered the week of July 27, 2020.
    Category
    Food
    Distribution
    37 states
  • HighCPSC·20189·2020-09-23

    Caravan Sports Arm Bagged Chairs Recalled for Fall and Injury Hazards

    Caravan Global is recalling about 2,700 Sports Armed/Padded Arm Bagged Chairs sold at H-E-B stores in Texas due to a defect that can cause the seat to rip from the frame.

    Product
    Caravan Sports Armed/Padded Arm Bagged Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2969-2020·2020-09-23

    Avanos MIC-KEY SF Gastrostomy Feeding Tube Recalled for Cracks

    Avanos Medical is recalling 284 units of MIC-KEY SF Gastrostomy Feeding Tubes because the devices had cracked or detached from the feeding tube body.

    Product
    AVANOS MIC-KEY SF Gastrostomy Feeding Tube
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2961-2020·2020-09-23

    Terumo Ultrasonic Air Sensor Recalled for Intermittent Connection Defect

    Terumo is recalling two Ultrasonic Air Sensors because a manufacturing defect may cause intermittent connections and false air bubble alarms during extracorporeal procedures.

    Product
    Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2966-2020·2020-09-23

    Randox Ammonia Reagent Recall Due to Positive Bias in Patient Samples

    Randox Laboratories is recalling 143 kits of the AM1054 Ammonia reagent because it shows a positive bias of up to 140 µmol/l on patient samples.

    Product
    AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2955-2020·2020-09-23

    Integra Padgett Electric Dermatome Set Recalled Due to Cable Melting

    Integra LifeSciences is recalling 2 units of the Padgett Electric Dermatome Set because the handpiece cable melts after sterilization.

    Product
    Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient wil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2954-2020·2020-09-23

    Integra Padgett Dermatome Set Recalled Due to Cable Melting

    Integra LifeSciences is recalling 13 dermatome sets because the handpiece cable melts after sterilization, posing a risk to patients and staff.

    Product
    Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be unde
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1613-2020·2020-09-23

    RLC Labs Recalls WP Thyroid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling WP Thyroid tablets because they were manufactured under conditions found to be subpotent. The recall covers lots expiring between October 2020 and July 2023.

    Product
    WP Thyroid, Westhroid Pure, 2 Grain (130 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5950-2 ; b) 30 Tablets, NDC 64727-5950-4; c) 60 Tablets, NDC 64727-5950-5; d) 90 Tablets, NDC 64727-5950-6; e) 100 Tablets, NDC 64727-5950-1; Rx Only, Manufactured by: RLC Labs Phoeni
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2980-2020·2020-09-23

    Medtronic Guardian Connect iOS App Recall Due to Data Upload Failure

    Medtronic is recalling the Guardian Connect iOS app because a software update stopped automatic data uploads to the CareLink Personal website.

    Product
    The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1610-2020·2020-09-23

    RLC Labs Recalls WP Thyroid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling WP Thyroid tablets because they were manufactured under conditions found to be subpotent. The recall covers lots expiring between October 2020 and July 2023.

    Product
    WP Thyroid, Westhroid Pure, 1.25 Grain (81.25 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-6050-2 ; b) 30 Tablets, NDC 64727-6050-4; c) 60 Tablets, NDC 64727-6050-5; d) 90 Tablets, NDC 64727-6050-6; e) 100 Tablets, NDC 64727-6050-1; Rx only, Manufactured by: RLC Labs P
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1609-2020·2020-09-23

    RLC Labs Recalls WP Thyroid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling WP Thyroid tablets because they were manufactured under conditions found to be subpotent. The recall covers lots expiring between October 2020 and July 2023.

    Product
    WP Thyroid, Westhroid Pure, 1 Grain (65 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-5750-2 ; b) 30 Tablets, NDC 64727-5750-4; c) 60 Tablets, NDC 64727-5750-5; d) 90 Tablets, NDC 64727-5750-6; e) 100 Tablets, NDC 64727-5750-1; Rx only, Manufactured by: RLC Labs Phoeni
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2962-2020·2020-09-23

    Randox Lactate Dehydrogenase Reagent Recalled for Carryover Avoidance Steps

    Randox Laboratories is recalling Lactate Dehydrogenase reagents to update technical bulletins with additional pipette wash steps to prevent reagent carryover and erroneous test results.

    Product
    Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1612-2020·2020-09-23

    RLC Labs Recalls WP Thyroid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling WP Thyroid tablets because they were manufactured under conditions associated with subpotent products.

    Product
    WP Thyroid, Westhroid Pure, 1.75 Grain (113.75 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-6150-2 ; b) 30 Tablets, NDC 64727-6150-4; c) 60 Tablets, NDC 64727-6150-5; d) 90 Tablets, NDC 64727-6150-6; e) 100 Tablets, NDC 64727-6150-1; Rx only, Manufactured by: RLC Labs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1602-2020·2020-09-23

    RLC Labs Recalls Nature-Throid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling Nature-Throid tablets because they were manufactured under conditions found to be subpotent.

    Product
    Nature-Throid, Thyroid USP [liothyronine (T3) 18 mcg and levothyroxine (T4) 76 mcg], 2 Grain (130 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3308-4; b) 60-count bottles, NDC 64727-3308-5; c) 90-count bottles, NDC 64727-3308-6; d) 100-count bottles, NDC 64727-3308-1;
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2963-2020·2020-09-23

    Randox Lactate Dehydrogenase Reagent Recall for Carryover Avoidance

    Randox Laboratories is recalling Lactate Dehydrogenase P-L reagent to address reagent carryover issues on RX instruments that may cause erroneous test results.

    Product
    Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX dayt
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2971-2020·2020-09-23

    Cook Medical Recalls Universa Soft Ureteral Stent Sets Due to Packaging Error

    Cook Inc. is recalling 20 units of Universa Soft Ureteral Stent Sets because they were incorrectly placed in boxes labeled for the Firm version.

    Product
    Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladder
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2958-2020·2020-09-23

    Boston Scientific Recalls Mislabeled WallFlex Biliary Stent Systems

    Boston Scientific is recalling 40 units of WallFlex Biliary RX stents that were mislabeled as fully covered devices. The error involves the 10mm x 60mm size.

    Product
    WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2968-2020·2020-09-23

    Tosoh Bioscience Recalls AIA-PACK BHCG Calibration Sets Due to Stability Issues

    Tosoh Bioscience is recalling 39 boxes of AIA-PACK BHCG Calibration Sets due to decreased stability that may cause inaccurate HCG concentration measurements.

    Product
    Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1605-2020·2020-09-23

    RLC Labs Recalls Nature-Throid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling Nature-Throid tablets because they were manufactured under conditions associated with subpotent products.

    Product
    Nature-Throid, Thyroid USP [liothyronine (T3) 27 mcg and levothyroxine (T4) 114 mcg], 3 Grain (195 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3312-4; b) 60-count bottles, NDC 64727-3312-5; c) 90-count bottles, NDC 64727-3312-6; d) 100-count bottles, NDC 64727-3312-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1508-2020·2020-09-23

    Coolhaus Ice Cream Sandwich Recalled for Undeclared Soy Lecithin

    Coolhaus is recalling specific lots of 'That Dough Though' ice cream sandwiches because the package label does not declare soy lecithin.

    Product
    Coolhaus Awesome Ice Cream -That Dough Though Ice Cream Sandwich; Chocolate chip cookies, cookie dough batter with gobs of cookie dough. Keep Frozen Contains: Milk, Wheat, Eggs 5.8 oz . serve package - polypropylene film wrapper. UPC: 8 51916 00349 0 Coolhaus, Culver
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Food)·F-1522-2020·2020-09-23

    Herr's Potato Chips Recalled for Undeclared Allergens and Ingredients

    Herr Foods Inc is recalling GameDay Tailgate Tacos Flavored Potato Chips due to undeclared black bean powder, jalapeno pepper powder, paprika, and other ingredients.

    Product
    Herr s GameDay Tailgate Tacos Flavored Potato Chips 6.5 oz. packaged in a flexible metalized bag. UPC Code: 7260006434
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-1596-2020·2020-09-23

    RLC Labs Recalls Nature-Throid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling Nature-Throid tablets because they were manufactured under conditions found to be subpotent.

    Product
    Nature-Throid, Thyroid USP [liothyronine (T3) 9 mcg and levothyroxine (T4) 38 mcg], 1 Grain (65 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3300-4; b) 60-count bottles, NDC 64727-3300-5; c) 90-count bottles, NDC 64727-3300-6; d) 100-count bottles, NDC 64727-3300-1; an
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1604-2020·2020-09-23

    RLC Labs Recalls Nature-Throid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling Nature-Throid tablets because they were manufactured under conditions associated with subpotency. The recall covers all lots with expiry dates between October 2020 and July 2023.

    Product
    Nature-Throid, Thyroid USP [liothyronine (T3) 22.5 mcg and levothyroxine (T4) 95 mcg], 2.5 Grain (162.5 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3310-4; b) 60-count bottles, NDC 64727-3310-5; c) 90-count bottles, NDC 64727-3310-6; d) 100-count bottles, NDC 64727-33
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2981-2020·2020-09-23

    Roche Recalls Anti-TPO Assay Kits Due to Updated Interference Claim

    Roche Diagnostics is recalling 11,870 Elecsys Anti-TPO Assay kits because internal studies found the radio frequency interference claim no longer met for specific cobas e analyzers.

    Product
    Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1598-2020·2020-09-23

    RLC Labs Recalls Nature-Throid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling Nature-Throid tablets due to manufacturing deviations. The products were manufactured under conditions found to be subpotent.

    Product
    Nature-Throid, Thyroid USP [liothyronine (T3) 4.5 mcg and levothyroxine (T4) 19 mcg], 1/2 Grain (32.5 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3299-4; b) 60-count bottles, NDC 64727-3299-5; c) 90-count bottles, NDC 64727-3299-6; d) 100-count bottles, NDC 64727-3299
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1599-2020·2020-09-23

    RLC Labs Recalls Nature-Throid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling Nature-Throid tablets due to Current Good Manufacturing Practice (CGMP) deviations. The product was manufactured under conditions found to be subpotent.

    Product
    Nature-Throid, Thyroid USP [liothyronine (T3) 11.25 mcg and levothyroxine (T4) 47.5 mcg], 1.25 Grain (81.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3303-4; b) 60-count bottles, NDC 64727-3303-5; c) 90-count bottles, NDC 64727-3303-6; d) 100-count bottles, NDC 647
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2959-2020·2020-09-23

    Terumo Ultrasonic Air Sensor Recall Due to Intermittent Connection

    Terumo is recalling 100 Ultrasonic Air Sensors because a manufacturing defect may cause false air bubble alarms during extracorporeal procedures.

    Product
    Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2967-2020·2020-09-23

    Tosoh Bioscience Recalls AIA-PACK HCG Calibrator Sets Due to Stability Issues

    Tosoh Bioscience is recalling five lots of AIA-PACK HCG Calibrator Sets because decreased stability may cause measured HCG concentrations to be up to 20% lower than actual.

    Product
    Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2957-2020·2020-09-23

    Maquet Rotaflow System Console Instructions for Use Recall

    Maquet Cardiovascular is recalling Instructions for Use for the Rotaflow System Console because the documents reference an incorrect serial number.

    Product
    Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit Material Number: 701043292
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1585-2020·2020-09-23

    Exela Pharma Recalls Potassium Acetate Injection Vials Due to Short Fill

    Exela Pharma Sciences LLC is voluntarily recalling 23,775 vials of Potassium Acetate Injection, USP due to short fill issues.

    Product
    Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured By: Exela Pharma Sciences, LLC. Lenoir, NC NDC 51754-2001-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2977-2020·2020-09-23

    Oxford Immunotec T-SPOT.TB50 Tuberculosis Test Kits Recalled for Labeling Error

    Oxford Immunotec is recalling T-SPOT.TB50 tuberculosis test kits due to incorrect expiration dates on the test kit and substrate labels.

    Product
    Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2976-2020·2020-09-23

    Oxford Immunotec Recalls T-SPOT.TB8 Kits Due to Incorrect Expiration Dates

    Oxford Immunotec is recalling 583 T-SPOT.TB8 test kits because they have incorrect expiration dates on the labeling.

    Product
    Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V570000·2020-09-22

    Nissan Recalls 2020 Altima, Maxima, and Leaf for Rear Window Defect

    Nissan is recalling 2020 Altima, Maxima, and Leaf vehicles because the rear window glass may not remain properly secured, increasing crash risk.

    Product
    NISSAN — NISSAN ALTIMA, MAXIMA, LEAF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V571000·2020-09-22

    Pierce Fire Apparatus Recalled for Joystick Controller Defect

    Pierce Manufacturing is recalling 2018-2020 Arrow XT, Dash, Enforcer, Impel, Quantum, and Velocity vehicles because the joystick controller may cause the aerial device to move without operator input.

    Product
    PIERCE — PIERCE IMPEL, QUANTUM, ARROW XT, ENFORCER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V568000·2020-09-21

    Nova Bus Recalls LFS Models Due to Power Steering Pipe Separation Risk

    Nova Bus is recalling 2019-2021 LFS and LFS ARTIC transit buses because power steering pipes may separate, causing fluid leaks and loss of steering assist.

    Product
    NOVA BUS — NOVA BUS LFS ARTIC, LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V569000·2020-09-21

    2021 Genesis G70 vehicles recalled for fuel pump assembly defects

    Hyundai recalls 2021 Genesis G70 vehicles (2.0L GDI engines) for a fuel pump defect. A manufacturing burr may block fuel flow, potentially causing engine stalls and crash risk.

    Product
    GENESIS — GENESIS G70
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V565000·2020-09-18

    Braxton Creek Bushwhacker Travel Trailer Recall for Floor Separation Risk

    Braxton Creek is recalling 2020-2021 Bushwhacker travel trailers because undersized lag bolts may allow the floor to separate from the frame, increasing crash risk.

    Product
    BRAXTON CREEK — BRAXTON CREEK BUSHWACKER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V566000·2020-09-18

    Newmar Recalls 2018-2021 Motorhomes Due to Tire Valve Stem Defect

    Newmar is recalling 2018-2019 Ventana and 2021 Canyon Star motorhomes because a tire valve stem extension may damage the inner wheel, risking loss of tire pressure and a crash.

    Product
    NEWMAR — NEWMAR VENTANA, CANYON STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V563000·2020-09-18

    Travel trailer brake system defect increases crash risk during separation

    Forest River is recalling certain 2018-2021 travel trailers because the breakaway safety switch may not engage the trailer brakes during separation from the tow vehicle. This defect can cause loss of vehicle control and increased crash risk.

    Product
    FOREST RIVER — FOREST RIVER WILDWOOD, SALEM, SONOMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E068000·2020-09-17

    Honda Recalls Tonneau Covers for 2017-2020 Ridgeline Trucks

    Honda is recalling specific tonneau covers for 2017-2020 Ridgelines because wind may cause panels to separate, creating a road hazard.

    Product
    HONDA — HONDA RIDGELINE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V562000·2020-09-17

    Motorhomes recalled for tire valve stem damage and pressure loss risk

    Forest River and Coachmen motorhomes (2018-2021) are recalled for tire valve stem damage that may cause pressure loss and crash risk. Owners should seek free replacement from the manufacturer.

    Product
    FOREST RIVER — FOREST RIVER, COACHMEN BERKSHIRE, SPORTSCOACH, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1428-2020·2020-09-16

    HelloFresh and EveryPlate Meal Kits Recalled Due to Salmonella Risk

    HelloFresh US is recalling approximately 694,090 meal kits containing onions received between June 25 and July 31, 2020, due to potential Salmonella contamination.

    Product
    Various HelloFresh and EveryPlate meal kits containing onions received by consumers from June 25 through July 31, 2020.
    Category
    Food
    Distribution
    46 states

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