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.

24976–25000 of 50443

  • HighFDA (Devices)·Z-2411-2019·2019-09-04

    Becton Dickinson Recalls Jamshidi Bone Marrow Biopsy Needles Due to Sterility Concerns

    Becton Dickinson is recalling 700 units of Jamshidi Crown Bone Marrow biopsy needles because product pouches may not be sealed properly, potentially compromising sterility.

    Product
    8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2401-2019·2019-09-04

    Siemens SOMATOM go.Up CT Systems Recalled for Falling Injector Holder

    Siemens is recalling three SOMATOM go.Up CT systems because the injector holder could fall off with the injector and storage box.

    Product
    SOMATOM go.Up; Models ##11061628 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-2419-2019·2019-09-04

    Stryker Endintrak 2 Hook Blade Recall Due to Compromised Sterile Seal

    Stryker GmbH is recalling 76 units of the Endintrak 2 Hook Blade because the sterile bag seal may be compromised, potentially affecting sterility.

    Product
    Endintrak 2 Hook Blade, Catalog Number 4058-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2372-2019·2019-09-04

    Bard Equistream Hemodialysis Catheter Recalled for Molded Tip Breakage

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

    Product
    EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903230, 14.5F, Straight ,23cm length, BARD, UDI: 00801741013706
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2395-2019·2019-09-04

    Bard Hemodialysis Catheter Recalled Due to Molded Tip Breakage

    Bard Peripheral Vascular Inc is recalling 140 units of GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397500, 14.5F, straight, 50cm length, BARD, UDI: 00801741012358
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2363-2019·2019-09-04

    Abbott Recalls Alinity ci Series System Control Modules Due to Software Error

    Abbott is recalling Alinity ci series System Control Modules because a software issue may cause incorrect test results after a system stop.

    Product
    Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2403-2019·2019-09-04

    Siemens SOMATOM go.All CT Scanner Injector Holder Recall

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

    Product
    SOMATOM go.All; Models #11061638 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-2368-2019·2019-09-04

    Bard Equistream Hemodialysis Catheter Recalled for Tip Breakage

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

    Product
    EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr. Alphacurve Catheter with Standard Kit, 19 cm length, BARD, UDI# 00801741013799
    Category
    Medical Device
    Distribution
    53 states
  • HighCPSC·19199·2019-09-04

    Artizen Oils Recalls Wintergreen and Birch Essential Oils for Packaging Defect

    Artizen Oils is recalling wintergreen and birch essential oils because the bottles lack required child-resistant caps, posing a poisoning risk to young children.

    Product
    Artizen Oils Wintergreen and Birch 100 percent Pure & Natural Therapeutic Grade Essential Oils
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2382-2019·2019-09-04

    Bard Equistream Hemodialysis Catheter Recalled for Tip Damage

    Bard Peripheral Vascular Inc is recalling Equistream XK 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:5913420, 16F, Straight, 42cm length, BARD, UDI: 00801741013881
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Food)·F-2108-2019·2019-09-04

    PreGel Lemon 50 Recalled for Undeclared Milk Allergen

    PreGel America, Inc. is recalling PreGel Lemon 50 because a complaint indicated the presence of undeclared milk, which is not listed on the ingredient statement.

    Product
    PreGel Lemon 50 4.4 lb (2kg) bag, Ingredients: dextrose, citric acid, mono and diglycerides of fatty acids, propane -1,2-diol esters of fatty acids, maltodextrins, carboxymethylcellulose, guar gum, flavors, dehydrated lemon juice, xanthan gum Manufactured by: PreGel America…
    Category
    Food
    Distribution
    28 states
  • HighFDA (Food)·F-2109-2019·2019-09-04

    Olive Bakery Red Bean Bread Recalled for Wheat Mislabeling

    Olive Bakery is recalling 41 packages of Red Bean Bread because the label lists flour but fails to declare wheat, a major allergen.

    Product
    Red Bean bread package contains two bread pastries filled with red bean paste filling, packaged 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…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2111-2019·2019-09-04

    Olive Bakery Recalls White Bean Bread for Wheat Allergen Mislabeling

    Olive Bakery is recalling White Bean bread because the label lists flour but fails to declare wheat, a major allergen. The product was distributed in Oregon and Washington.

    Product
    White Bean bread is filled with white bean paste filling and topped with black sesame seeds, two pieces 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…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2383-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

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

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393190, 14.5F, Straight, 19cm length, BARD, UDI: 00801741012174
    Category
    Medical Device
    Distribution
    53 states
  • HighCPSC·19776·2019-09-04

    John Deere Recalls XUV835 Gator Utility Vehicles Due to Throttle Hazard

    John Deere is recalling about 19,730 XUV835 Gator utility vehicles because the throttle cable sheathing can melt, causing the throttle to stick and posing a crash hazard.

    Product
    John Deere XUV835 Gator utility vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2092-2019·2019-09-04

    Whole Foods Recalls 365 Organic Pecan Oatmeal for Undeclared Allergen

    Whole Foods Market is recalling 365 Organic Maple & Brown Sugar Pecan Instant Oatmeal cups due to undeclared pecans. The product was distributed in Washington, Idaho, and Oregon.

    Product
    365 Organic Maple & Brown Sugar Pecan Instant Oatmeal 2.3 oz (65 g) microwaveable cups that are sold individually
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2399-2019·2019-09-04

    Siemens SOMATOM go.Now CT Systems Recalled for Injector Holder Risk

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

    Product
    SOMATOM go.Now; Models #11061610 & 11061618 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-2371-2019·2019-09-04

    Bard Hemodialysis Catheter Recalled Due to Tip Breakage During Placement

    Bard Peripheral Vascular Inc is recalling 1,356 EQUISTREAM Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during the placement procedure.

    Product
    EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903190, 14.5F, Straight ,19cm length, BARD, UDI# 00801741013690
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Food)·F-2116-2019·2019-09-04

    Olive Bakery Cream Horns Recalled for Undeclared Wheat and Soy Allergens

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

    Product
    Cream Horns packages contain one bread pastry filled with non-dairy whipped cream filling. Product is packaged 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…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2389-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling 104 units of GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396280, 14.5F, Alphacurve, 28cm length, BARD, UDI: 00801741012266
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2375-2019·2019-09-04

    Bard Equistream Hemodialysis Catheter Recalled for Molded Tip Defects

    Bard Peripheral Vascular Inc is recalling 39 units of Equistream Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5904270, 14.5F, Straight ,27cm length, BARD, UDI: 00801741013775
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Food)·F-2114-2019·2019-09-04

    Olive Bakery Mocha Cream Bread Recalled for Allergen Mislabeling

    Olive Bakery is recalling Mocha Cream bread packages in Oregon and Washington because the labels fail to declare wheat, almond, and soy lecithin.

    Product
    Mocha Cream bread packages contain two bread pastries and each filled with a coffee filling with almonds on the outside. 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 (Devices)·Z-2404-2019·2019-09-04

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

    Siemens is recalling 12 SOMATOM go.Top CT scanners because the injector holder could fall off. The devices are distributed in 20 US states.

    Product
    SOMATOM go.Top; Models #11061640 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-2422-2019·2019-09-04

    Stryker Endotrac EPF/EGR Triangle Blade Recall for Compromised Sterile Seal

    Stryker GmbH is recalling 21 Endotrac EPF/EGR Triangle Blades because the sterile bag seal integrity may be compromised, posing a risk of contamination.

    Product
    Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide