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.

21301–21325 of 50426

  • HighFDA (Devices)·Z-0820-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0840-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid concentrate drums recalled for conductivity deviation

    Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate drums due to deviations in sodium conductivity and calcium concentration.

    Product
    Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0825-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid concentrate drums recalled for low sodium levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate drums because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0832-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid concentrate bottles recalled for conductivity deviation

    Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to deviations in sodium conductivity and calcium concentration.

    Product
    Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0839-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid concentrate drums recalled for conductivity deviation

    Fresenius Medical Care is recalling 224 drums of Naturalyte Liquid Acid concentrate due to deviations in conductivity and calcium concentration.

    Product
    Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21E004000·2021-01-19

    Auxbeam Headlight Bulb Recall for Excessive Glare and Brightness

    Guangzhou Zhilan E-Commerce is recalling specific Auxbeam headlight bulbs sold on Amazon that may create excessive glare for oncoming drivers, increasing crash risk.

    Product
    EXTERIOR LIGHTING:HEADLIGHTS:BULBS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-01152021-01·2021-01-15

    USDA Issues Alert for Beef Jerky with Undeclared Anchovy Allergen

    USDA FSIS issued a public health alert for specific beef jerky brands due to undeclared anchovies and misbranding. Consumers with anchovy allergies should discard the products.

    Product
    FSIS Issues Public Health Alert for Beef Jerky Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·21V011000·2021-01-15

    Ford Escape rear drive axle lubricant defect may cause loss of control

    Ford is recalling approximately 147 2020 Ford Escape vehicles and related models due to inadequate lubricant in the rear drive unit, which may cause the rear axle to seize and result in loss of vehicle control and crash risk.

    Product
    FORD — FORD, LINCOLN ESCAPE, CORSAIR, EDGE, NAUTILUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V013000·2021-01-15

    2021 KZRV Recreational Trailers Recalled for Improper Microwave Circuit Protection

    KZRV recalls 2021 Escape, Sonic, and Sportsmen Classic trailers with microwave circuits on improper 20-amp circuit breakers (should be 15-amp), creating fire risk. Owners should request free replacement from KZRV.

    Product
    KZRV — KZRV ESCAPE, SONIC, SPORTSMEN CLASSIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V010000·2021-01-14

    2019-2021 Honda Odyssey fuel tank assembly recall due to fire risk

    Braun Corporation is recalling certain 2018-2021 Honda Odyssey vehicles due to a fuel tank assembly defect that may cause fuel leaks, creating a potential fire risk. No injuries have been reported.

    Product
    HONDA — HONDA ODYSSEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21719·2021-01-14

    Scalpa Numb Topical Anesthetic Cream Recalled for Child-Resistant Packaging Failure

    Scalpa Inc. is recalling Scalpa Numb Maximum Strength Topical Anesthetic Cream because the packaging does not meet child-resistant requirements, posing a poisoning risk to young children.

    Product
    Scalpa Numb Maximum Strength Topical Anesthetic Cream
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21V009000·2021-01-14

    2021 Heartland Mallard recreational trailers recalled for suspension defect

    Heartland is recalling certain 2021 Mallard M180BH recreational trailers with incorrect axle, rims, and tires that can cause overloading and increase crash risk. Free replacement parts are available.

    Product
    HEARTLAND — HEARTLAND MALLARD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0801-2021·2021-01-13

    Ortho-Clinical VITROS Automation Software Recall for Sample Labeling Errors

    Ortho-Clinical Diagnostics is recalling VITROS Automation Solutions software due to a defect that may cause samples to be mislabeled, potentially leading to incorrect patient results.

    Product
    VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0779-2021·2021-01-13

    Medline Recalls Non-X-Ray Detectable Surgical Sponges in Convenience Kits

    Medline Industries is recalling 88 surgical convenience kits because the cylindrical sponge component is not x-ray detectable. The affected products were distributed only in Canada.

    Product
    Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0803-2021·2021-01-13

    Roche CoaguChek XS Prof Meters Recalled for Potential Unit Misinterpretation

    Roche is recalling CoaguChek XS Prof meters because they may display results in incorrect units, potentially leading to misinterpretation of warfarin monitoring data.

    Product
    CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Catalog: 04837975001 Units could consist of any of the following strip configurations: 6 count, 24 count, 2x 24…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0802-2021·2021-01-13

    DePuy Pinnacle Hip Cups Recalled for Potential Cross-Threaded Apex HE Fixation

    DePuy Orthopaedics is recalling Pinnacle Hip Cups because the Apex HE screw may thread through the cup shell without stopping, potentially protruding internally.

    Product
    Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0783-2021·2021-01-13

    Medline Cardiac Pack Recall for Non-X-Ray Detectable Sponge Component

    Medline Industries is recalling Cardiac Pack - LF kits because the cylindrical sponge component is not x-ray detectable. The affected units were distributed only in Canada.

    Product
    Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0804-2021·2021-01-13

    Roche CoaguChek XS PST Meters Recalled for Potential Unit Misinterpretation

    Roche is recalling CoaguChek XS PST meters because they may display blood-clotting results in the wrong units. Users should verify their meter is set to INR.

    Product
    CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 04837738001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0193-2021·2021-01-13

    Rich Products Cake Truffles Recalled for Undeclared Wheat

    Rich Products Corp is recalling 589 cases of Cake Truffles because the product contains undeclared wheat.

    Product
    OUR SPECIALTY; Cake Truffles; Variety; Chocolate; Cookies 'N Creme; NO: Artificial Colors, Flavors, or High Fructose Corn Syrup; Net Wt. 19.5 oz(1 LB 3.5 oz) (552 g)
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0774-2021·2021-01-13

    Boston Scientific Recalls AXIOS Stent Delivery System Due to Fitting Detachment Risk

    Boston Scientific is recalling 32 units of the AXIOS Stent and Electrocautery - Enhanced Delivery System because a fitting may detach, risking peritonitis.

    Product
    AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0767-2021·2021-01-13

    Linet Eleganza 5 Adjustable Bed Recalled for Side Rail Malfunction

    Linet Spol. S.r.o. is recalling 518 Eleganza 5 adjustable beds because a side rail component may malfunction, causing the rail to fail to lock or become stuck in the upper position.

    Product
    Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1GE512055-45, c) 1GE512055-85, and d) 1GE512055-95 - Product Usage: Eleganza 5 is a positionable bed for intensive care. Its purpose is to support patient and to facilitate treatment and manipulation with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21067·2021-01-13

    Juratoys Recalls Janod Toy Trumpets Due to Choking Hazard

    Juratoys is recalling Janod Toy Confetti Trumpets because small plastic pieces can come loose and pose a choking hazard to children.

    Product
    Janod Toy Confetti Trumpets
    Category
    Consumer Product
    Distribution
    Distributed nationwide