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.

24076–24100 of 50442

  • HighFDA (Food)·F-0548-2020·2020-01-22

    Wegmans Recalls Lobster Stuffed Haddock Due to Undeclared Soy

    Wegmans is recalling Lobster Stuffed Haddock because the product contains undeclared soy. Consumers in seven states should check their refrigerators or freezers.

    Product
    Lobster Stuffed Haddock; Wegmans Ready to Cook Lobster Stuffed Haddock, 8 oz; Oven ready tray; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0543-2020·2020-01-22

    Wegmans Recalls Crab Stuffed Portobella for Undeclared Soy

    Wegmans is recalling Crab Stuffed Portobella mushrooms due to undeclared soy. The product was sold in seven states.

    Product
    Crab Stuffed Portobella; Wegmans Ready to Cook Portobella Mushroom with Crab Stuffing, Sold by the lb; Unit size varies; Oven ready tray; Package size varies; Keep Refrigerated
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0806-2020·2020-01-22

    Carestream Recalls Kodak DirectView DR3000/3500 X-Ray Systems for U-Arm Movement

    Carestream Health is recalling 79 Kodak DirectView DR3000/3500 diagnostic x-ray systems due to a potential safety issue involving unintended movement of the U-Arm.

    Product
    Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for examination of various anatomical regions. The DR Operator Console is the user interface. All operator functions except positioning the Bucky…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0798-2020·2020-01-22

    CooperSurgical Recalls Advanced Endosee Cannulas Due to Unsealed Pouches

    CooperSurgical is recalling 460 boxes of Advanced Endosee Cannulas because some sterile pouches may be unsealed, potentially compromising sterility.

    Product
    ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a sterile, single-use cannula that is part of the Advanced Endosee System. The cannula contains a light source and a camera…
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Food)·F-0560-2020·2020-01-22

    Tobago Keys Seafood and Grilling Sauces Recalled for Undeclared Fish Allergen

    Endorphin Farms, Inc. is recalling Tobago Keys brand sauces due to mislabeling that resulted in an undeclared fish allergen.

    Product
    Tobago Keys brand Coral Ridge Seafood Dipping Sauce 12 FL.OZ. (355 ml) and Peruvian Gold Grilling Sauce 12 FL.OZ (355 ml)
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0540-2020·2020-01-22

    Wegmans Recalls Crab Stuffed Flounder Due to Undeclared Soy

    Wegmans is recalling Ready to Cook Crab Stuffed Flounder because the product contains undeclared soy. Consumers should not eat the product.

    Product
    Crab Stuffed Flounder; Wegmans Ready to Cook Crab Stuffed Flounder; 7oz; Oven Ready Tray; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0551-2020·2020-01-22

    Wegmans Recalls Crabmeat Stuffed Mushrooms for Undeclared Soy

    Wegmans is recalling Ready to Cook Crabmeat Stuffed Mushrooms sold in seven states because they contain undeclared soy.

    Product
    Crabmeat Stuffed Mushrooms; Wegmans Ready to Cook Crabmeat Stuffed Mushrooms, Sold by the lb; Unit size varies; Oven Ready Tray; Package size varies; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Drugs)·D-0758-2020·2020-01-22

    Recall of Assurance Infusion Morphine Injection for Sterility Concerns

    Assurance Infusion is recalling Morphine 4mg/mL Injection in 20mL syringes due to lack of sterility assurance. The recall affects specific lots distributed nationwide.

    Product
    MORPHINE 4MG/ML INJ in 20mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0538-2020·2020-01-22

    Wegmans Recalls Crab Pretzel Twists Due to Undeclared Soy

    Wegmans is recalling Ready to Pretzel Twist with Crab Stuffing because the product contains undeclared soy. Consumers with this product should not eat it.

    Product
    Crab Pretzel Twist; Wegmans Ready to Pretzel Twist with Crab Stuffing, 1 each; 14oz; Oven ready tray; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0802-2020·2020-01-22

    Flexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components

    Flexicare Medical Ltd. is recalling BriteBlade Pro laryngoscope blades because internal spring, washer, and bearing components may become loose and separate from the device.

    Product
    BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0536-2020·2020-01-22

    Wegmans Recalls Ready-to-Cook Crab Stuffing for Undeclared Soy

    Wegmans is recalling Ready to Cook Crab Stuffing sold in seven states because the product contains undeclared soy.

    Product
    Crab Stuffing; Wegmans Ready to Cook Crab Stuffing, Sold by the lb; Unit size varies; Oven ready tray; package size varies, Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0544-2020·2020-01-22

    Wegmans Recalls Crab Stuffed Sea Bass for Undeclared Soy

    Wegmans is recalling Crab Stuffed Sea Bass because the product contains undeclared soy. Consumers with soy allergies should not eat the product.

    Product
    Crab Stuffed Sea Bass; Wegmans Ready to Cook Sea Bass with Crab Stuffing, 6 oz; Oven Ready Tray; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0808-2020·2020-01-22

    St. Jude Medical Recalls Confirm Rx Insertable Cardiac Monitors

    St. Jude Medical is recalling 2,906 Confirm Rx Insertable Cardiac Monitors because a software defect caused inappropriate low battery indicators.

    Product
    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0545-2020·2020-01-22

    Wegmans Recalls Seafood Lobster Dip for Undeclared Soy

    Wegmans is recalling Seafood Lobster Dip sold in multiple states because the product contains undeclared soy.

    Product
    Seafood Lobster Dip; Wegmans Lobster Dip, Sold by the lb; Unit size varies; Oven ready tray; Package size varies; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0537-2020·2020-01-22

    Wegmans Recalls Crab Stuffed Hot Peppers Due to Undeclared Soy

    Wegmans is recalling Ready to Cook Crab Stuffed Hot Peppers because they contain undeclared soy. The product was sold in seven states.

    Product
    Crab Stuffed Hot Peppers; Wegmans Ready to Cook Crab Stuffed Hot Peppers, Sold by the lb; Unit size varies; Oven ready tray; Package size varies; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0541-2020·2020-01-22

    Wegmans Recalls Crab Stuffed Tilapia for Undeclared Soy

    Wegmans is recalling Crab Stuffed Tilapia because the product contains undeclared soy. The recall affects stores in seven states.

    Product
    Crab Stuffed Tilapia; Wegmans ready to Cook Tilapia Stuffed with Crab; 8 oz; Oven ready tray; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0804-2020·2020-01-22

    Flexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components

    Flexicare Medical Ltd. is recalling BriteBlade Pro laryngoscope blades because internal components may become loose and separate, posing a risk of entering the patient's oral cavity.

    Product
    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0539-2020·2020-01-22

    Wegmans Recalls Crab Stuffed Hatch Chile Peppers Due to Undeclared Soy

    Wegmans is recalling Crab Stuffed Hatch Chile Peppers because they contain undeclared soy. Consumers should not eat the product.

    Product
    Crab Stuffed Hatch Chile; Wegmans Ready to Cook Hatch Chile Peppers with Crab Stuffing, Sold by the lb; Unit size varies; Oven ready tray; Package size varies; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0815-2020·2020-01-22

    Cook Inc. Recalls Dawson-Mueller Drainage Catheters Due to Leakage Risk

    Cook Inc. is recalling specific lots of Dawson-Mueller Drainage Catheters because they were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly.

    Product
    Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-25-P-58-CLDM-HC, UL T7.0-35-25-P-5S-CLDM-HC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0803-2020·2020-01-22

    Flexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components

    Flexicare Medical Ltd. is recalling BriteBlade Pro laryngoscope blades because internal spring, washer, and bearing components may become loose and separate from the device.

    Product
    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055788724138(17)230801(10)180900072 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0552-2020·2020-01-22

    Wegmans Recalls Lobster Stuffed Tilapia for Undeclared Soy

    Wegmans is recalling Lobster Stuffed Tilapia because the product contains undeclared soy. Consumers with soy allergies should not eat the product.

    Product
    Lobster Stuffed Tilapia; Wegmans Ready to Cook Lobster Stuffed Tilapia, 7 oz; Unit size 7oz; Oven Ready Tray; Package size 7oz; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0542-2020·2020-01-22

    Wegmans Recalls Salmon with Crab Stuffing Due to Undeclared Soy

    Wegmans is recalling Salmon with Crab Stuffing because the product contains undeclared soy. Consumers should not eat the product and should return it to the store.

    Product
    Salmon with Crab Stuffing; Wegmans Salmon Topped with Crab Stuffing; 8 oz; Oven ready tray; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0550-2020·2020-01-22

    Wegmans Recalls Lobster Stuffed Mushrooms for Undeclared Soy

    Wegmans is recalling Lobster Stuffed Mushrooms because they contain undeclared soy. The product was sold in seven states.

    Product
    Lobster Stuffed Mushrooms; Wegmans Ready to Cook Lobster Stuffed Mushrooms, Sold by the lb; Unit size varies; Oven ready tray; Package size varies; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0816-2020·2020-01-22

    Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillators Due to Keypad Oxidation

    Physio-Control is recalling 29,952 LIFEPAK 15 Monitor/Defibrillators worldwide because oxidation on the keypad may prevent the device from delivering a shock.

    Product
    LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad.
    Category
    Medical Device
    Distribution
    Distributed nationwide