The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

8776–8800 of 29123

  • SevereUSDA FSIS·001-2021·2021-01-02

    Courage Production Recalls Polish Sausage for Undeclared Milk Allergen

    Courage Production, LLC. is recalling ready-to-eat Polish sausage products because they contain undeclared milk (mozzarella cheese), a known allergen.

    Product
    Courage Production, LLC. Recalls Ready-to-Eat, Fully Cooked Polish Sausage Products due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0607-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events during use.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0603-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Sheath Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events during use.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0606-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0611-2021·2020-12-30

    Cook Inc. Recalls Flexor Tuohy-Borst Side-Arm Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Tuohy-Borst Side-Arm Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events.

    Product
    Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC, Order Number G31138 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0598-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Sheath Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events during use.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0605-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, posing a risk of life-threatening adverse events.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0597-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0174-2021·2020-12-30

    Morton Grove Recalls Hydroxyzine Hydrochloride Oral Solution Due to Impurities

    Morton Grove Pharmaceuticals is recalling Hydroxyzine Hydrochloride Oral Solution because it failed impurity specifications, including an unknown degradant.

    Product
    Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0171-2021·2020-12-30

    SCA Pharmaceuticals Recalls Subpotent Vasopressin Injection Bags

    SCA Pharmaceuticals is recalling 654 bags of Vasopressin 20 Units in 0.9% Sodium Chloride because the drug was subpotent.

    Product
    Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dose Container, SCA Pharmaceuticals 8821 Knoedl Ct. Little Rock, AR 72205 Bar Code 70004093232
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0707-2021·2020-12-30

    ICU Medical Recalls ChemoLock Administration Sets Due to Molding Defect

    ICU Medical is recalling specific ChemoLock administration sets because a molding defect may cause leaks. This could lead to fluid path contamination or exposure to hazardous medications.

    Product
    31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3011; 40" (102 cm) Appx 4.9 ml, Admin Set w/ChemoLock, 20 Drop In-Line Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3020; ChemoLock Port w/Spiros, Red Cap, REF: CL-35; 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0608-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling 228 Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0600-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events during use.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0604-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G56222 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0601-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0596-2021·2020-12-30

    Flexor Check-Flo Introducer sheath separation recall due to potential life-threatening complications

    The FDA is recalling the Flexor Check-Flo Introducer because its sheath may separate at the proximal bond site, potentially causing serious complications such as embolization, vessel injury, or hemorrhage.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0181-2021·2020-12-30

    Maribel's Sweets Recalls Dark Chocolate Pearls Due to Undeclared Milk

    Maribel's Sweets, Inc. is recalling Cacao Market Marie Belle New York Dark Chocolate Pearls because the product contains undeclared milk.

    Product
    CACAO MARKET MARIE BELLE NEW YORK; Dark Chocolate Pearls; Ingredients: Cocoa bean, sugar, biscuit cereals (wheat flour, sugar, wheat malt, wheat starch, raising agent: E500ii, palm oil, salt, vanilla flavoring 17%, cocoa butter, emulsifier (soy lecithin), natural vanilla extract;
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Devices)·Z-0592-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling 383 Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events during use.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G56234 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0609-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Sheath Separation Risk

    Cook Inc. is recalling 631 Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0602-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0610-2021·2020-12-30

    Cook Inc. Recalls Flexor Tuohy-Borst Side-Arm Introducers Due to Separation Risk

    Cook Inc. is recalling 902 Flexor Tuohy-Borst Side-Arm Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.

    Product
    Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number G31133 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0653-2021·2020-12-30

    CryoLife Recalls CryoPatch SG Pulmonary Human Cardiac Patch Units

    CryoLife, Inc. is recalling two units of CryoPatch SG Pulmonary Human Cardiac Patch due to post-processing microbial culture test failures.

    Product
    CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0593-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducer Sheaths Due to Separation Risk

    Cook Inc. is recalling 458 Flexor Check-Flo Introducer sheaths because the proximal bond site may separate, potentially causing life-threatening adverse events such as embolization or hemorrhage.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0594-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, posing a risk of life-threatening adverse events.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0595-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G56235 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide