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.

7926–7950 of 22104

  • HighFDA (Food)·F-0624-2025·2025-03-19

    Green Chile Bean Burritos Recalled for Undeclared Milk Allergen

    Mi Ranchito Foods is recalling Green Chile Bean Burritos because milk is not listed in the ingredient statement, posing a risk for consumers with milk allergies.

    Product
    Green Chile Bean Burrito, 15 days refrigerated at 33 45 degrees Fahrenheit. 120 days frozen at or below 32 degrees Fahrenheit. Packaged in cellophane wrapper. Net wt. 10 ounces, UPC #21856 11136. Mi Ranchito Foods, Inc. 606 Central Avenue, Bayard, NM 88023
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1313-2025·2025-03-19

    TruScan Body dental scanner recalled due to scanning malfunction

    TruAbutment Inc. recalls 61 units of the TruScan Body dental scanner (CN38-SB) due to defects that may prevent proper or accurate scanning.

    Product
    Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software Version: N/A
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Food)·F-0610-2025·2025-03-19

    Genova Solid White Tuna Recalled for Potential Botulism Contamination

    Chicken of the Sea recalls Genova branded solid white tuna nationwide due to improperly secured easy-pull lids that may allow Clostridium botulinum contamination.

    Product
    Genova branded Solid white Tuna; In Olive Oil; Wild Caught; NET WT. 5 OZ (142g) RD WT. 4 OZ (113g); Distributed by Tri-Union Seafoods, LLC.; El Sugundo, CA 90245 U.S.A. UPC# 48000 00215,
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1324-2025·2025-03-19

    Philips Spectral CT on Rails software recall due to scanning and movement issues

    Philips is recalling one unit of Spectral CT on Rails software version 5.1.0 due to multiple software problems causing scanning issues, image errors, and unintended device movement.

    Product
    Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1321-2025·2025-03-19

    ZOLL Powerheart G5 AED devices may fail self-test in extreme environments

    ZOLL is recalling Powerheart G5 AED devices that may fail their self-test when exposed to extreme temperature or humidity, potentially affecting proper device operation.

    Product
    Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrilla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1328-2025·2025-03-19

    Stryker CinchLock anchor recalled due to pullwire breakage

    Stryker is recalling its CinchLock Flex Knotless Anchor due to an increase in pullwire breakage complaints. The broken pullwire may remain in the implant body after deployment.

    Product
    Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0261-2025·2025-03-19

    Drug Recall: Alprostadil Affected by Manufacturing Practice Deviations

    Alprostadil 3.0 gm is being recalled due to manufacturing practice deviations. Limited distribution affects product with lot number HAALC0020922 (expiration August 2025).

    Product
    Alprostadil Container Description: Amber color bottle
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0276-2025·2025-03-19

    Kids by babyganics mineral sunscreen recalled for chemical contamination

    Kids by babyganics SPF 50 mineral sunscreen spray is being recalled due to chemical contamination. Consumers using affected batches should stop use immediately.

    Product
    Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ spray bottles, Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403, UPC 813277019923 and UPC 813277019916
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0614-2025·2025-03-19

    Trader Joe's Canned Yellowfin Tuna Recalled for Improperly Sealed Lids

    Trader Joe's Solid Light Yellowfin Tuna is being recalled because the easy-pull lid may not be properly secured, potentially allowing botulism contamination. Approximately 14,147 cases nationwide are affected.

    Product
    Trader Joe's branded Solid Light Yellowfin Tuna in olive oil, Pole & Line Caught; NET WT. 5 OZ (142g) DR WT. 4 OZ (113g); Dist & Sold Exclusively By: Trader Joe's, Monrovia, CA 91816; UPC# 51403
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0264-2025·2025-03-19

    Latanoprost medication recalled due to manufacturing practice deviations

    Aspen Biopharma Labs is recalling Latanoprost medication due to manufacturing practice deviations. The voluntary recall affects product distributed to distributors in Hong Kong and Florida.

    Product
    Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-1297-2025·2025-03-19

    GE Healthcare Revolution CT Systems: Coolant Fluid Leak Creates Slip Hazard

    GE Healthcare Revolution Apex and Revolution CT series systems may leak coolant fluid onto the floor near the gantry. The blue-colored, non-toxic fluid poses a slip and fall hazard if not noticed.

    Product
    GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0269-2025·2025-03-19

    Duloxetine 60mg Capsule Recall Due to Manufacturing Impurity

    Breckenridge Pharmaceutical recalls 11,100 bottles of Duloxetine 60mg capsules distributed nationwide due to the presence of N-nitroso-duloxetine impurity exceeding FDA recommended interim limits from manufacturing deviations.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0263-2025·2025-03-19

    Chemotherapy drug Chlorambucil recalled for manufacturing process deviations

    Aspen Biopharma Labs is voluntarily recalling Chlorambucil due to manufacturing process deviations. The product was distributed to distributors in Hong Kong and Florida.

    Product
    Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-1327-2025·2025-03-19

    Blood Pump Recalled for Potential Fluid Leakage During Clinical Use

    Spectrum Medical is recalling Quantum Perfusion blood pumps due to potential fluid leakage during priming or clinical use. The issue affects approximately 1,487 units distributed nationwide.

    Product
    Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-VT Software Version: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1329-2025·2025-03-19

    Z1 Femoral Hip System Recalled Over Stem Inserter Design Issue

    Zimmer, Inc. is recalling 35 units of the Z1 Femoral Hip System due to a potential design issue with the Z1 Offset Stem Inserter that could cause fracturing of the distal tip.

    Product
    Z1 Femoral Hip System, Product Number 611777612
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1308-2025·2025-03-19

    Hemostatic Forceps Recalled Due to Clamp Breakage in Surgical Use

    Aesculap Inc is recalling 19,979 hemostatic forceps across 18 models because clamps can break when instruments are used outside of design specifications.

    Product
    Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJ501R, Phaneuf Hysterectomy Forceps ANG 205MM; (3) REF BJ511R, Holzbach Hyst Forceps CVD245MM; (4) REF BJ520R, Heaney Hyst Forceps Grooved 205MM; (5) REF BJ52
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0615-2025·2025-03-19

    Trader Joe's Canned Albacore Tuna Recalled for Potential Botulism Contamination

    Trader Joe's Solid White Albacore Tuna is being recalled because the easy-pull lid may not be properly secured, risking contamination with botulism bacteria.

    Product
    Trader Joe's branded Solid White Albacore Tuna in olive oil; NET WT. 5 OZ (142g) DR WT. 4 OZ (113g); Dist & Sold Exclusively By: Trader Joe's, Monrovia, CA 91816; UPC# 99287
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1300-2025·2025-03-19

    GE Healthcare Revolution CT systems coolant leak creates slipping hazard

    Certain GE Healthcare Revolution CT and Apex series systems may leak coolant fluid near the gantry base, creating a potential slip-fall hazard if left unnoticed.

    Product
    GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0274-2025·2025-03-19

    Walgreens Acne Control Cleanser recalled for benzene contamination

    Walgreens Acne Control Cleanser with 10% benzoyl peroxide is being recalled nationwide due to benzene contamination. The affected lot (23-09328, exp. 09/2025) was distributed across the U.S.

    Product
    Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL, Made in Canada. UPC#: 1 9560203602 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1322-2025·2025-03-19

    ZOLL Powerheart G5 AED Self-Test May Fail Under Extreme Environmental Conditions

    ZOLL is recalling certain Powerheart G5 AED units that may fail their self-test when exposed to extreme temperatures or humidity. The affected devices could fail to function properly in emergencies.

    Product
    Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9) G5S-80-L (10) G5S-90A; Software Version: NA Product Description: The Powerheart G5 automa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1315-2025·2025-03-19

    Cartilage Transplant System Disposable Kits Recalled for Missing Component

    DePuy Mitek is recalling COR Disposable Kit cartilage transplant systems because some units lack the pin in the graft loader component. The manufacturing defect may prevent proper device function during surgical use.

    Product
    COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0271-2025·2025-03-19

    Duloxetine Capsules Recalled for N-Nitroso Impurity Exceeding FDA Limits

    Breckenridge Pharmaceutical is recalling 11,125 bottles of Duloxetine 20mg capsules nationwide due to N-nitroso-duloxetine impurity above FDA-recommended limits. The impurity was detected during quality control testing.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1299-2025·2025-03-19

    GE Healthcare CT Systems May Leak Coolant Fluid on Floor

    GE Healthcare Revolution CT and Apex series systems can leak coolant fluid onto the floor near the gantry, creating a slip and fall hazard. The blue-colored fluid is non-corrosive and not hot, but poses injury risk if not noticed.

    Product
    GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1311-2025·2025-03-19

    Multiple hemostatic forceps models recalled due to clamp breakage risk

    Aesculap is recalling 1,147 hemostatic forceps due to clamp breakage risk when used beyond design specifications. Units were distributed nationwide and internationally to healthcare providers.

    Product
    Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD 215MM; (2) REF FB459R, Glover ATR.CLAMP CVD 245MM; (3) REF FB461R, Glover ATR.CLAMP 195MM; (4) REF FB462R, Glover ATR.CLAMP 210MM; (5) REF FB469R, Leland-Jones Peripheral CLMPSTR 195MM;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1319-2025·2025-03-19

    ZOLL Powerheart G5 AED May Fail Self-Test in Extreme Environmental Conditions

    ZOLL is recalling certain Powerheart G5 AED models that may fail their self-test function when exposed to extreme temperature or humidity. Affected devices might not function properly in emergencies.

    Product
    Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C, (9) G5A-41C, (10) G5A-85C, (11) G5A-90C (12) G5A-80-L; Software Version: NA Product Description: The
    Category
    Medical Device
    Distribution
    Distributed nationwide