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.

40801–40825 of 50511

  • HighFDA (Devices)·Z-2062-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP CTS Coagulation Instruments

    Instrumentation Laboratory is recalling 572 ACL TOP CTS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP CTS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V449000·2014-07-23

    Forest River Recalls 2013-2014 RVs with Defective Microwaves

    Forest River is recalling specific 2013-2014 recreational vehicles because the installed Frigidaire microwaves may start heating on their own, posing a fire risk.

    Product
    FOREST RIVER — FOREST RIVER SUNSEEKER, CEDAR CREEK, PATHFINDER, GEORGETOWN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2070-2014·2014-07-23

    Excelsior Medical Recalls Sterile Triple Lead Tubing Sets Due to Leak Risk

    Excelsior Medical is recalling sterile triple lead tubing sets because a molding defect may allow fluid leaks or air entry during use.

    Product
    Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. To be used with the Pharm-Assist Dispensing Pump. Used for drug reconstitution and/or fluid transfer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2029-2014·2014-07-23

    Terumo Sarns Centrifugal Pump Recalled for Pumphead Leaks

    Terumo is recalling specific lots of Sarns Disposable Centrifugal Pumps because leaks were detected on the pumphead during set-up and priming.

    Product
    Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2186-2014·2014-07-23

    Zing Nutrition Bars Recalled for Undeclared Milk

    NW Nutritional Foods LLC is recalling Zing Nutrition Bars because they contain undeclared milk despite being labeled as dairy-free or vegan.

    Product
    There are two different labels for this product same UPC codes. Version #1 individual bars: 100% natural Zing Complete Nutrition, CHOCOLATE COCONUT, Gluten, Soy & Dairy Free, NET WT. 1.76 OZ. (50g). Version # 1 display carton: Zing Complete Nutrition, Gluten, Soy &…
    Category
    Food
    Distribution
    46 states
  • HighFDA (Food)·F-2192-2014·2014-07-23

    Schnucks Bakery Devil's Food Cake Recalled for Undeclared Pecan Allergen

    Schnucks Markets is recalling Devil's Food Cakes because the label fails to list pecan pieces, a tree nut allergen.

    Product
    Schnucks Bakery 8" Devil's Food Cake, net wt. 2 lb 13 oz, UPC: 04131831186. Also packaged as Schnucks Bakery Half Devil's Food Cake, net wt. 1 lb 7 oz plastic, UPC: 04131831078 Schnuck Markets, Inc., St. Louis, MO.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2064-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 500 CTS Coagulation Instruments

    Instrumentation Laboratory is recalling ACL TOP 500 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 500 CTS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2045-2014·2014-07-23

    Smith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach

    Smith & Nephew is recalling 259 units of SUTUREFIX Ultra Anchor XL devices because a breach in the sterile barrier compromised the device's sterility.

    Product
    SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2185-2014·2014-07-23

    Zing Dark Chocolate Hazelnut Bars Recalled for Undeclared Milk

    NW Nutritional Foods LLC is recalling Zing Dark Chocolate Hazelnut bars because they contain undeclared milk despite being labeled as dairy-free or vegan.

    Product
    There are 2 different labels for this same product with the same UPC. Label #1 Individual Bars: 100% natural Zing Complete Nutrition, DARK CHOCOLATE HAZELNUT, Gluten, Soy & Dairy Free, NET WT. 1.76 OZ. (50g), Manufactured For: Zing Bars Seattle, WA 98125. Label #1…
    Category
    Food
    Distribution
    46 states
  • HighFDA (Food)·F-2188-2014·2014-07-23

    Zing Nutrition Bars Recalled for Undeclared Milk

    NW Nutritional Foods LLC is recalling Zing Nutrition Bars labeled 'dairy free' because they contain undeclared milk.

    Product
    Individual Bars: 100% Natural Zing Nutrition Bar, CASHEW CRANBERRY ORANGE, Gluten, Dairy & GMO Free, NET WT. 1.76 OZ (50g), Manufactured For: Zing Bars Seattle, WA 98125. Display Carton: Zing Complete Nutrition, Gluten, Soy & Dairy Free, 100% natural CASHEW CRANBERRY…
    Category
    Food
    Distribution
    46 states
  • HighFDA (Devices)·Z-2028-2014·2014-07-23

    Terumo Sarns Centrifugal Pump Recalled for Pumphead Leaks

    Terumo is recalling Sarns Disposable Centrifugal Pumps because leaks were detected on the pumphead during set-up and priming.

    Product
    Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2189-2014·2014-07-23

    Betty Lou's Chocolate Dream Greens Recalled for Undeclared Milk

    Betty Lou's, Inc. is recalling Just Great Stuff Chocolate Dream Greens bars due to undeclared milk, a contaminant of the dark chocolate ingredient.

    Product
    Just Great Stuff Chocolate Dream Greens, 42 g bar, The bars are individually wrapped and packed in a display containing 12 bars. The displays are shrink wrapped.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2048-2014·2014-07-23

    Smith & Nephew Recalls SUTUREFIX Ultra S Suture Due to Sterility Breach

    Smith & Nephew is recalling SUTUREFIX Ultra S sutures because the sterile barrier is compromised, posing a risk of infection.

    Product
    SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2055-2014·2014-07-23

    Stryker Communications Recalls SHAPE Arm Brackets for Boom Systems

    Stryker Communications is recalling 953 SHAPE Arm brackets used in operating rooms because the monitor mount may detach if specific hardware is missing.

    Product
    BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as component of kit part number 0682000976, and the Arm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2053-2014·2014-07-23

    Stryker SHAPE Arm Dual SH2 Recalled for Potential Monitor Detachment

    Stryker Communications is recalling SHAPE Arm Dual SH2 brackets because the monitor mount may detach if specific hardware is missing.

    Product
    SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400254 and the Arm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2056-2014·2014-07-23

    Stryker Communications Recalls SHAPE Arm Brackets for Potential Monitor Detachment

    Stryker Communications is recalling 953 SHAPE Arm brackets because the monitor mount may detach if a lock washer and screw are missing.

    Product
    BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682000977, and the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2061-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 700 Coagulation Instruments

    Instrumentation Laboratory is recalling 633 ACL TOP 700 automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 700, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2063-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 700 LAS Coagulation Instruments

    Instrumentation Laboratory is recalling 99 ACL TOP 700 LAS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 700 LAS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2059-2014·2014-07-23

    Mindray V-Series Patient Monitoring System Recalled for ECG Interpretation Errors

    Mindray is recalling 113 V-Series Patient Monitoring Systems due to software issues causing false ECG measurements and incorrect interpretive statements.

    Product
    V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2049-2014·2014-07-23

    Smith & Nephew Recalls SUTUREFIX Ultra S Sutures Due to Sterility Breach

    Smith & Nephew is recalling 763 units of SUTUREFIX Ultra S Double Loaded Sutures because the sterile barrier was breached, compromising the device's sterility.

    Product
    SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 700 CTS Coagulation Instruments

    Instrumentation Laboratory is recalling 266 ACL TOP 700 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 700 CTS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14236·2014-07-22

    Oeuf Recalls Sparrow Cribs Due to Entrapment Hazard

    Oeuf LLC is recalling about 14,000 Sparrow cribs because slats and top rails can detach, posing an entrapment hazard to children.

    Product
    Sparrow Cribs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·047-2014·2014-07-22

    Sara Lee Foodservice Recalls Smoked Sausage Due to Undeclared Soy Allergen

    Sara Lee Foodservice is recalling smoked sausage products because they contain undeclared soy protein, a known allergen. No adverse reactions have been reported.

    Product
    Wisconsin Firm Recalls Sausage Product Due To Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide