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.

26051–26075 of 50450

  • HighFDA (Devices)·Z-1206-2019·2019-05-01

    Arthrex Burr Recalled for Excessive Heat Generation During Use

    Arthrex, Inc. is recalling specific lots of Arthrex Oval Burr devices because they may generate excessive heat during use, posing a risk of injury to patients.

    Product
    Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in both large and small articular cavities during arthroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1215-2019·2019-05-01

    Stryker Performance Series Sagittal Blade Recall for Sterility Breach

    Stryker is recalling 355 Performance Series Sagittal Blades due to a potential breach in sterility caused by improper packaging positioning during manufacture.

    Product
    Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are used in the cutting and shaping of bone and other bone related tissue in various orthopedic procedures. Typical procedures include, total-knee…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1218-2019·2019-05-01

    Jelco ViaValve Safety Intravenous Catheters Recalled for Manufacturing Defect

    Smiths Medical ASD Inc. is recalling specific lots of Jelco ViaValve safety intravenous catheters due to a V-shaped puncture at the base of the catheter.

    Product
    Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R) ViaValve(TM) safety I.V. catheter is a sterile, non pyrogenic, single use, radiopaque intravascular catheter device used for the administration of medically…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19E032000·2019-04-30

    Strategic Sports Recalls Zox Sierra ST-560 Motorcycle Helmets

    Strategic Sports is recalling Zox Sierra ST-560 helmets because they may not adequately protect the wearer in a crash. Owners should return the helmet for a full refund.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V331000·2019-04-30

    Southeast Apparatus Recalls 2017-2018 Fire Trucks Due to Brake Light Defect

    Southeast Apparatus is recalling 39 fire trucks from 2017-2018 because Whelen brake lights may illuminate without the brake pedal being pressed, potentially confusing other drivers.

    Product
    SOUTHEAST APPARATUS — SOUTHEAST APPARATUS PUMPER, TANKER, RESCUE TRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V333000·2019-04-29

    New England Wheels Recalls Modified Ford Transit and Ram Promaster Vehicles

    New England Wheels is recalling 2014-2018 Ford Transit and 2014-2019 Ram Promaster vans modified with Freedman Go-ES Foldaway seats because the seat cushions may not stay locked in place during a crash.

    Product
    FORD — FORD, RAM TRANSIT, PROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19111·2019-04-25

    Viessmann Recalls Vitodens Boilers Due to Carbon Monoxide Hazard

    Viessmann is recalling Vitodens 200-W and 222-F boilers because a corroded heat exchanger can leak flue gases, posing a carbon monoxide poisoning hazard.

    Product
    Vitodens boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V326000·2019-04-25

    Jaguar Recalls 2014-2015 F-TYPE Vehicles for Air Bag Sensor Wiring Issue

    Jaguar is recalling 2014-2015 F-TYPE vehicles because a seatbelt sensor wiring error may cause the front passenger air bag to deploy incorrectly, increasing injury risk for children.

    Product
    JAGUAR — JAGUAR F-TYPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19742·2019-04-25

    TriDerma Recalls Pain Relief Cream for Child-Resistant Packaging Failure

    TriDerma is recalling Pain Relief Cream with Lidocaine because the packaging fails to meet child-resistant closure requirements, posing a poisoning risk to young children.

    Product
    Pain Relief Cream with Lidocaine
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1176-2019·2019-04-24

    ProSun Onyx 32 Sli Intensive Tanning Bed Recalled for UV Output Discrepancies

    ProSun International is recalling 31 Onyx 32 Sli Intensive tanning beds due to quality control documentation discrepancies that could result in high UV output.

    Product
    ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX 32 SLI INTENSIVE PEARL WHITE, ANYTIME FITNESS ONYX 32 SLI INTENSIVE BRONZE, PROSUN ONYX 32 SLI INTENSIVE BRONZE Tanning of the skin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1133-2019·2019-04-24

    BioFire FilmArray BCID Panel Recall for False Positive Blood Culture Results

    BioFire Diagnostics is recalling FilmArray BCID Panels used with specific BACT/ALERT blood culture bottles due to an increased risk of false positive results for Enterobacteriaceae and E. coli.

    Product
    FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1197-2019·2019-04-24

    Abbott Alinity c Processing Module Recalled for Safety Interlock Defect

    Abbott is recalling 559 Alinity c Processing Modules because a safety interlock may fail to deploy when a bulk solution bottle is removed.

    Product
    Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1180-2019·2019-04-24

    Gyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk

    Gyrus ACMI is recalling Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with Olympus consoles.

    Product
    Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1289-2019·2019-04-24

    Boston Salads Recalls Edamame Salad Due to Possible Metal Fragment Contamination

    Boston Salads & Provisions Co., Inc. is recalling 915 pounds of Edamame Salad due to possible metal fragment contamination. The product was distributed in MA, CT, RI, NH, and NY.

    Product
    Edamame Salad sold under the following labels: BOSTON SALADS Prepared Foods EDAMAME SALAD NET WT 5lb. KEEP REFRIGERATED AT 32-38 DEGREE FAHRENHEIT UPC 10611140153166; and Sensational EDAMAME SALAD NET WT WEIGHT 5 lb KEEP REFRIGERATED AT 32-40 DEGREES UPC 10022878100245
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1187-2019·2019-04-24

    Gyrus ACMI Recalls Diego Elite Malleable Monopolar Blades

    Gyrus ACMI is recalling 161 Diego Elite Malleable 4mm Standard Monopolar Blades because they may allow unintended RF energy activation when used with Diego Elite consoles.

    Product
    Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1199-2019·2019-04-24

    GE Healthcare Recalls Innova IGS 630 Angiographic X-Ray System

    GE Healthcare is recalling one Innova IGS 630 angiographic X-ray system because a specific user action may cause a loss of imaging function.

    Product
    Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1192-2019·2019-04-24

    Medrobotics Flex Robotic System Obturators Recalled for Weld Failure Risk

    Medrobotics is recalling 24 Flex Robotic System obturators because a weld may break, causing the rod to separate from the cone.

    Product
    Obturator (shortcone), Part number 26114 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1205-2019·2019-04-24

    Teva Recalls Subpotent Amoxicillin Oral Suspension Bottles Nationwide

    Teva Pharmaceuticals is recalling specific lots of Amoxicillin Oral Suspension because assay results were below specification limits. The affected bottles were distributed nationwide and in Puerto Rico.

    Product
    Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9, Manufactured For: Teva Pharmaceuticals USA, INC. North…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1137-2019·2019-04-24

    bioMerieux Recalls Vitek 2 Test Kits Due to False ESBL Results

    bioMerieux is recalling Vitek 2 test kits because they may incorrectly identify Escherichia coli as having an ESBL phenotype.

    Product
    Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1145-2019·2019-04-24

    Roche Bilirubin Total Gen.3 Recalled for Potential Medical Risk

    Roche Diagnostics is recalling Bilirubin Total Gen.3 assays due to new endogenous interference claims that may pose a potential medical risk.

    Product
    Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/19***05795397190, 05795648190 Product Usage: In vitro test for the quantitative determination of total bilirubin in serum and plasma of adults and neonates…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1181-2019·2019-04-24

    Gyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk

    Gyrus ACMI is recalling 82 Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with Olympus consoles.

    Product
    Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1143-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Estradiol Cypionate Vials for Sterility Concerns

    Anderson Compounding Pharmacy is recalling 35 vials of Estradiol Cypionate 10 mg/mL due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Estradiol Cypionate 10 mg/mL, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide