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.

16001–16025 of 53092

  • HighFDA (Devices)·Z-1681-2022·2022-09-14

    ChemoLock Infusion Ports Recalled for Unintended Disconnection Risk

    ICU Medical recalls ChemoLock chemotherapy infusion ports for potential unintended disconnection due to spring variation, which may delay therapy and expose patients to caustic substances.

    Product
    Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX 1.5ml,ChemoLock BAG SPIKE WITH ADDITIVE PORT/CL-13; ChemoLock Port/CL2100; ChemoLock Port, 5 Units/CL2100-5; ChemoLock Port/CL2100T; Clave Bag…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1700-2022·2022-09-14

    Select Bakery cake recalled for undeclared soy allergen

    Select Bakery Old Fashion Strawberry Creme Cake is being recalled due to undeclared soy. The affected product was distributed in Georgia, North Carolina, and South Carolina.

    Product
    Select Bakery Old Fashion Strawberry Creme Cake Net Wt. 3 Oz (85g) Select Bakery, Inc., Rockwell, N.C. 28138 UPC 0 28598 10013 1
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1692-2022·2022-09-14

    PICC and Central Line Packs Exposed to Unvalidated Sterilization Cycles

    American Contract Systems is recalling PICC line and central line packs due to exposure to multiple sterilization cycles without validation. Two units were distributed to healthcare facilities in 13 U.S. states.

    Product
    Various PICC Line, Central Line Packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1693-2022·2022-09-14

    ENT Surgical Packs Recalled Due to Sterilization Validation Failure

    American Contract Systems recalls various ENT surgical packs that may not have been properly sterilized due to multiple sterilization cycles without adequate validation. The packs were distributed to healthcare facilities in 13 states.

    Product
    Various ENT Packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1700-2022·2022-09-14

    Neurology Surgical Packs Recalled for Sterilization Validation Failure

    American Contract Systems recalls 37 units of neurology surgical packs distributed across 13 US states due to exposure to multiple sterilization cycles without proper validation.

    Product
    Various neurology packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Food)·F-1686-2022·2022-09-14

    King's Hawaiian Pretzel Buns Recalled for Potential Bacterial Contamination

    King's Hawaiian pretzel hamburger buns, slider buns, and pretzel bites are recalled nationwide. An ingredient used in manufacturing may contain Cronobacter sakazakii or Clostridium botulinum.

    Product
    King's Hawaiian 10.5 oz. Pretzel Hamburger Buns (UPC 73435000365), 10.2 oz. Pretzel Bites (UPC 73435000525.), and 11 oz. Slider Buns (UPC 73435000372 ) packed in plastic bags. Distributed by King s Hawaiian Bakery West, Inc., 19161 Harborgate Way, Torrance, CA 90501
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1689-2022·2022-09-14

    Angiography Packs Recalled Due to Sterilization Validation Failure

    American Contract Systems, Inc. is recalling 57 angiography packs and trays that were exposed to multiple sterilization cycles without proper validation for repeated sterilization exposure.

    Product
    Various Angiography packs/trays
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Food)·F-1702-2022·2022-09-14

    Select Bakery Walnut Creme Cake Recall: Undeclared Soy and Sulfites

    Select Bakery is recalling Old Fashion Walnut Creme Cake because it contains undeclared soy and sulfites not listed on the label. People with allergies to soy or sulfites should not consume this product.

    Product
    Select Bakery Old Fashion Walnut Creme Cake Net Wt. 3 Oz (85g) Select Bakery, Inc., Rockwell, N.C. 28138 UPC 0 28598 10028 5
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1707-2022·2022-09-14

    Piantedosi Frozen Dinner Rolls Recalled for Bacterial Contamination

    Piantedosi Baking Co. is recalling Soft Dinner Roll No Seeds 24-packs due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. The recall affects 18,119 frozen trays distributed across 15 states.

    Product
    Soft Dinner Roll No Seeds Unsliced 24-pack (033474400960)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-1705-2022·2022-09-14

    Eye Surgery Packs Recalled Due to Improper Sterilization Validation

    American Contract Systems is recalling various eye and cataract surgery packs distributed to US health systems because the products were exposed to multiple sterilization cycles without validation. Unvalidated sterilization may compromise device sterility.

    Product
    Various eye packs, cataract packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Food)·F-1689-2022·2022-09-14

    Select Bakery Cheerwine bakery product recall for undeclared allergens and additives

    Select Bakery is recalling Cheerwine net weight 3 oz bakery products due to undeclared soy, Red #40, and sulfites. Products were distributed in Georgia, North Carolina, and South Carolina.

    Product
    Select Bakery Cheerwine Net Wt. 3 oz (85g) Select Bakery, Inc., Rockwell, N.C. 28138 UPC 0 28598 10033 9
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1704-2022·2022-09-14

    D&C Pack Recall Due to Sterilization Validation Failure

    American Contract Systems is recalling D&C packs that were exposed to multiple sterilization cycles without proper validation. The sterilization failure may compromise device sterility.

    Product
    D&C pack
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Drugs)·D-1491-2022·2022-09-14

    Guaifenesin and Dextromethorphan Cough Syrup Recalled for Manufacturing Control Deviations

    Plastikon Healthcare LLC is recalling Guaifenesin and Dextromethorphan cough syrup cups distributed nationwide due to manufacturing processes that were not adequately controlled.

    Product
    GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6980-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·22V686000·2022-09-14

    2022 Ford F-150 Parking Light Flickering Defect Recall

    Ford is recalling 2022 F-150 trucks and 2022-2023 Bronco Sport vehicles due to a lighting control module defect causing parking light flickering when headlights are activated. The flickering reduces visibility and increases crash risk.

    Product
    FORD — FORD F-150, BRONCO SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1710-2022·2022-09-14

    Frozen SPR Rolls Recalled for Cronobacter and Botulinum Contamination

    Piantedosi Baking Co. is recalling SPR Roll 12-packs due to potential contamination with Cronobacter sakazakii and Clostridium botulinum bacteria. Affected products were distributed across 15 states.

    Product
    SPR Roll 12-pack (033474501339)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Drugs)·D-1493-2022·2022-09-14

    CORRECTDOSE Children's Pain Relief and Fever Reducer Acetaminophen Recalled for Manufacturing Control Violations

    CORRECTDOSE Children's Fever Reducer (160 mg/5 mL acetaminophen) has been recalled due to manufacturing control deviations. The recall affects 1,464 units distributed nationwide.

    Product
    CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-311-05 UPC 8 60003 67145 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1713-2022·2022-09-14

    Frozen Burger Rolls Recalled for Potential Bacterial Contamination

    Piantedosi Baking Co. is recalling B & W Sweet Burger Roll 12-packs due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. The affected products were distributed across 15 U.S. states.

    Product
    B & W Sweet Burger Roll 12-pack (033474502947)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-1703-2022·2022-09-14

    C-Section Surgical Packs recalled for improper sterilization validation

    American Contract Systems recalls C-section surgical packs that were exposed to multiple sterilization cycles without validation. The sterilization integrity of the 24 affected units cannot be assured.

    Product
    Various C-section packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Food)·F-1698-2022·2022-09-14

    Bakery cakes recalled due to undeclared soy allergen in three states

    Select Bakery is recalling Old Fashion Pineapple Creme Cake (3 oz) due to undeclared soy. The voluntary recall affects products distributed in Georgia, North Carolina, and South Carolina.

    Product
    Select Bakery Old Fashion Pineapple Creme Cake Net Wt. 3 Oz (85g) Select Bakery, Inc., Rockwell, N.C. 28138 UPC 0 28598 10012 4
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1696-2022·2022-09-14

    Port Insertion Packs Recalled Due to Unvalidated Sterilization

    American Contract Systems is recalling Various Port Insertion Packs that were exposed to multiple sterilization cycles without proper validation. The devices may not meet sterility standards.

    Product
    Various Port Insertion Packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1697-2022·2022-09-14

    Breast Abdominoplasty Pack Recalled for Inadequate Sterilization Cycle Validation

    American Contract Systems, Inc. is recalling Breast Abdominoplasty Packs that were exposed to multiple sterilization cycles without validation that the process could safely maintain instrument sterility through repeated exposures.

    Product
    Breast Abdominoplasty Pack
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Drugs)·D-1498-2022·2022-09-14

    Difluprednate Eye Drops Recalled for Defective Container Compromising Sterility

    CIPLA is recalling 3,468 bottles of Difluprednate Ophthalmic Emulsion nationwide due to defective protective caps that could expose the dropper tip and compromise sterility. No injuries have been reported.

    Product
    Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1687-2022·2022-09-14

    Undersized Dilator in Balloon Catheter Insertion Kit Recalled

    Datascope Corporation is recalling certain lots of an Insertion Kit for intra-aortic balloon catheters due to undersized dilators. The defect affects 10,427 units distributed in the U.S. and internationally.

    Product
    Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1688-2022·2022-09-14

    VYGON Dressing Change Kit Recalled for Potential Seal Integrity Issues

    Stradis Healthcare is recalling VYGON DRESSING CHANGE W/MAXISWAB kits due to potential incomplete seals that could compromise product sterility. Affected consumers should stop using recalled kits.

    Product
    VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
    Category
    Medical Device
    Distribution
    1 state