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.

24951–24975 of 50443

  • HighFDA (Devices)·Z-2476-2019·2019-09-11

    Roche cobas e 601 Module Recalled for Inaccurate Results

    Roche Diagnostics is recalling cobas e 601 modules due to a quality issue with high pressure solenoid valves that may cause inaccurate test results.

    Product
    cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2438-2019·2019-09-11

    BD Kiestra InoqulA Software Version 20.3.IVD Recalled for Specimen Mismatch Risk

    Becton Dickinson & Co. is recalling 4 units of BD Kiestra InoqulA Software Version 20.3.IVD due to an anomaly that may cause specimen and plate mismatches.

    Product
    BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2469-2019·2019-09-11

    B. Braun Medical Recalls Epidural Tuohy Needle Filters Due to Membrane Damage

    B. Braun Medical is recalling 540 units of CE17TKN epidural Tuohy needle filters because the filter membrane is damaged, preventing the device from achieving its intended filter capacity.

    Product
    CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2471-2019·2019-09-11

    B. Braun Medical Recalls Con Epi Tray Due to Filter Membrane Damage

    B. Braun Medical is recalling 200 units of Con Epi Trays because damage to the filter membrane prevents the device from achieving its required filter capacity.

    Product
    CE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT Catalog # 339187
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2472-2019·2019-09-11

    B. Braun Medical Recalls Accu-Bloc Perifix Kits Due to Filter Damage

    B. Braun Medical is recalling 3,820 units of Accu-Bloc Perifix Kits because damage to the filter membrane prevents the device from achieving its intended filter capacity.

    Product
    CE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2477-2019·2019-09-11

    Roche Recalls Cobas 8000 Analyzer Modules Due to Valve Quality Issue

    Roche Diagnostics is recalling 19 Cobas 8000 Modular Analyzer Series units due to a quality issue with high pressure solenoid valves.

    Product
    Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2467-2019·2019-09-11

    B. Braun Recalls Spinal and Epidural Trays Due to Filter Damage

    B. Braun Medical is recalling 200 units of spinal and epidural trays because the filter membrane is damaged, preventing the device from achieving required filter capacity.

    Product
    ES1827KN SPINAL/EPIDURAL TRAY NRFIT Catalog # 339115
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-2107-2019·2019-09-11

    Nice! Espresso Trail Mix Recalled for Undeclared Sulfites

    Suntree Snack Foods is recalling Nice! Espresso Trail Mix because it contains undeclared sulfites, a common allergen.

    Product
    Nice! Espresso Trail Mix, Net Wt 2.5 Oz (70g) Pouch. Distributed by Sun Tree Snack Foods, LLC, Ambient Storage
    Category
    Food
    Distribution
    0 states
  • HighCPSC·19204·2019-09-10

    Ragdoll & Rockets Recalls Children's Loungewear for Flammability Violation

    Ragdoll & Rockets is recalling about 14,100 units of children's loungewear because the items fail to meet federal flammability standards for sleepwear, posing a risk of burn injuries.

    Product
    Children's loungewear
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19200·2019-09-10

    Healing Solutions Recalls Essential Oils for Child-Resistant Packaging Failure

    Healing Solutions is recalling Wintergreen and Birch essential oils because the bottles lack required child-resistant caps, posing a poisoning risk to young children.

    Product
    Healing Solutions Wintergreen and Birch 100 percent Pure Therapeutic Grade Essential Oils
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19203·2019-09-10

    DIANA Stormrider Gen 2 Air Rifles Recalled for Unexpected Discharge Risk

    DIANA is recalling Stormrider Gen 2 air rifles because they can unexpectedly discharge even when the safety is engaged, posing a risk of serious injury or death.

    Product
    DIANA® Stormrider Gen 2 Air Rifles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V648000·2019-09-09

    Mercedes-Benz Recalls 2020 GLE Models for Missing Head Restraint Manual Info

    Mercedes-Benz is recalling 2020 GLE 350 and GLE 450 vehicles because the owner's manuals lack instructions for adjusting third-row head restraints, violating federal safety standards.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE 350, GLE 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V644000·2019-09-06

    GM Recalls 2019 Chevrolet Express and GMC Savana for Seatbelt Warning Defect

    General Motors is recalling 2019 Chevrolet Express and GMC Savana vehicles because the seatbelt-unfastened warning light may fail to illuminate for five seconds after ignition.

    Product
    GMC — GMC, CHEVROLET SAVANA, EXPRESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V646000·2019-09-06

    Temsa Recalls Buses Due to Inadequate Emergency Exit Window Labels

    Temsa is recalling 2013-2020 TS35C, TS35E, and TS45 buses because emergency exit window labels may not clearly describe how to open them quickly.

    Product
    TEMSA — TEMSA TS35C, TS45, TS35E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V642000·2019-09-06

    GM Recalls 2018 Chevrolet Malibus Due to Engine Software Error

    General Motors is recalling 2018 Chevrolet Malibus with 1.5L turbo engines because a software error may disable fuel injectors, causing the engine to stall.

    Product
    CHEVROLET — CHEVROLET MALIBU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19201·2019-09-05

    STIHL PolyCut Mowing Heads Recalled Due to Injury Hazard

    STIHL is recalling about 73,000 PolyCut mowing heads because loose bolts can cause the unit to come apart, posing an injury risk.

    Product
    STIHL PolyCut ™ Mowing Heads
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19779·2019-09-05

    Walker Edison Recalls Children's Bunk Beds Due to Fall Hazards

    Walker Edison Furniture is recalling about 1,200 children's bunk beds because support boards can break, posing fall and injury hazards.

    Product
    Children's bunk beds
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2113-2019·2019-09-04

    Olive Bakery Cream Bread Recalled for Allergen Mislabeling

    Olive Bakery is recalling cream bread packages because the label fails to declare wheat and soy lecithin, posing a risk to consumers with allergies.

    Product
    Cream bread packages contain two bread pastries filled with custard filling. They are packaged together in a clear plastic bag with a fold down stick seal. No net weight or nutritional information is included on the label. The packaging contains white printing label and…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2379-2019·2019-09-04

    Bard Equistream XK Hemodialysis Catheter Recall for Tip Defects

    Bard Peripheral Vascular Inc is recalling Equistream XK Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913270, 16F, Straight, 27cm length, BARD, UDI: 00801741013850
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2405-2019·2019-09-04

    Siemens SOMATOM go.Top CT Scanner Recall for Falling Injector Holder

    Siemens is recalling SOMATOM go.Top CT scanners because the injector holder could fall off with the injector and storage box.

    Product
    SOMATOM go.Top; Models #11061648 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2377-2019·2019-09-04

    Bard Equistream XK Hemodialysis Catheter Recalled for Tip Defect

    Bard Peripheral Vascular Inc is recalling Equistream XK Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913190, 16F, Straight, 19cm length, BARD, UDI: 00801741013836
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Food)·F-2110-2019·2019-09-04

    Olive Bakery Green Bean Bread Recalled for Undeclared Wheat Allergen

    Olive Bakery is recalling Green Bean bread because the label lists flour but fails to declare wheat, a major allergen.

    Product
    Green Bean bread topped with black sesame seeds, packaged together in a clear plastic bag with a fold down stick seal. No net weight or nutritional information is included on the label. The packaging contains white printing label and reads in part: ***Olive bakery…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2119-2019·2019-09-04

    Olive Bakery Sweet Potato Bread Recalled for Wheat Mislabeling

    Olive Bakery is recalling three packages of Sweet Potato Bread because the label lists flour but fails to declare wheat, a major allergen.

    Product
    Sweet Potato bread packages contain two bread pastries filled with white bean paste filling topped with black sesame seeds and cinnamon. They are packaged together in a clear plastic bag with a fold down stick seal. No net weight or nutritional information is included on the…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2380-2019·2019-09-04

    Bard Equistream XK Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling 46 units of Equistream XK Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913350, 16F, Straight, 35cm length, BARD, UDI: 00801741013874
    Category
    Medical Device
    Distribution
    53 states