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.

14051–14075 of 22168

  • HighFDA (Devices)·Z-2606-2023·2023-09-27

    DJO Surgical Reverse Shoulder System Components Recalled Due to Missing Sterilization

    Reverse shoulder implant components were shipped without final sterilization, potentially leading to infection and possible revision surgery if implanted. Encore Medical is recalling 64 units distributed across the US and internationally.

    Product
    DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder System (RSP) Glenoid, Neutral Head W/ Retaining Screw, 36mm, REF: 508-36-101
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Drugs)·D-1165-2023·2023-09-27

    TRP Natural Eyes Stye Relief sterile eye ointment recalled for lack of sterility assurance

    FDA is recalling TRP Natural Eyes Stye Relief sterile eye ointment due to lack of assurance of sterility. The product was distributed to two accounts in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-014-13.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-1175-2023·2023-09-27

    Humanrace Suncare SPF 30 Sunscreen Recalled for Subpotent Protection

    HUMANRACE is recalling Humanrace Suncare Ozone Face Protection Daily Moisturizer SPF 30 because the product does not contain the declared SPF level. Affected consumers should discontinue use immediately.

    Product
    Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30, packaged as a 53mL (1.8 fl oz.) bottle, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1167-2023·2023-09-27

    octiq Lubricating Eye Drops Recalled Due to Sterility Assurance Defect

    Innovus Pharmaceuticals recalled octiq Lubricating Eye Drops due to lack of assurance of sterility. The affected lot was distributed to accounts in Rhode Island and Colorado.

    Product
    octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus Pharmaceuticals, Inc., Englewood, CO 80112, Made in Jordan, NDC:57483-610-15.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2617-2023·2023-09-27

    PDS II Surgical Sutures Recalled for Tensile Strength Defect

    ETHICON is recalling specific lots of PDS II surgical sutures after internal testing confirmed some units did not meet tensile strength requirements. Approximately 868,363 units were distributed in the United States and globally.

    Product
    PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z416H-50, Z
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1157-2023·2023-09-27

    Sterile Eye Drops Recalled for Lack of Sterility Assurance TRP Natural Eyes

    TRP Natural Eyes sterile eye drops have been recalled because their sterility cannot be confirmed. About 8,000 units distributed to medical accounts in Rhode Island and Colorado are affected.

    Product
    TRP Natural Eyes, Eye Lid Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-417-19.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2604-2023·2023-09-27

    DJO Surgical Orthopedic Implants Recalled for Sterilization Failure

    DJO Surgical orthopedic implants (lot 878B1171) were shipped without sterilization and may cause infection if implanted, potentially requiring treatment, monitoring, or revision surgery. Contact your healthcare provider to verify your lot number.

    Product
    DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Drugs)·D-1156-2023·2023-09-27

    FDA Recalls TRP Natural Eyes Eye Drops for Sterility Concerns

    FDA is recalling TRP Natural Eyes Dryness Relief eye drops due to lack of assurance of sterility. Approximately 83,898 units were distributed to accounts in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Dryness Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-096-19.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-1153-2023·2023-09-27

    TRP Natural Eyes sterile eye drops recalled due to lack of sterility assurance

    AMMAN PHARMACEUTICAL INDUSTRIES is recalling TRP Natural Eyes Allergy Relief eye drops due to inability to assure sterility. The recalled lot includes 8,810 units distributed to accounts in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-097-19.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-1164-2023·2023-09-27

    TRP Natural Eyes Red Eye Relief eye drops recalled due to sterility concerns

    TRP Natural Eyes Red Eye Relief PF sterile eye drops are being recalled due to lack of assurance of sterility. Approximately 196,442 units distributed to accounts in Rhode Island and Colorado may be affected.

    Product
    TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-095-19.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2603-2023·2023-09-27

    Orthopedic knee implant component lacks final sterilization before shipment

    Encore Medical recalls 20 DJO Surgical Empowr Knee tibia baseplate components that were not sterilized before shipment. If implanted, these components may cause infection requiring treatment or revision surgery.

    Product
    DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2601-2023·2023-09-27

    Stryker ACM System Femoral Nozzle Recall for Potential Disassembly

    Stryker is recalling its ACM Advanced Cement Mixing System due to a defect in the Break-Away Femoral Nozzle that can disassemble or break off during surgical use, risking loss of device function and foreign material in the surgical site.

    Product
    Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-703-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1542-2023·2023-09-27

    Sauce Product Recalled for Undeclared Soy Allergen in Texas

    Somebody's Mother's Island Sauce is recalled due to undeclared soy. Consumers with soy allergies may have an allergic reaction if exposed to this product.

    Product
    Somebody's Mother's Island Sauce, Net Wt 9.5 oz (270g), UPC 5803100115
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2595-2023·2023-09-27

    Medline Iris Scissors Recalled Due to Detachable Tip Protector Risk

    Medline is recalling 324,451 sterile iris scissors because the tip protector may detach, exposing a sharp point that could puncture sterile packaging and compromise instrument sterility.

    Product
    MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1166-2023·2023-09-27

    TRP Natural Eyes Sterile Eye Ointment Recalled for Lack of Sterility Assurance

    TRP Natural Eyes Sterile Eye Ointment is recalled due to lack of assurance of sterility. The product was distributed to two accounts in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Twitching Relief, Sterile Eye Ointment, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-099-15.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2618-2023·2023-09-27

    Omnipod 5 App Software Error Prevented Control on Android Phones

    Omnipod 5 app users on certain Android phones encountered an error that prevented remote control of the insulin delivery system. The issue delayed therapy access but did not interrupt automatic insulin delivery, and was resolved by Insulet restoring cloud security settings.

    Product
    Omnipod 5 Automated Insulin Delivery System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-1155-2023·2023-09-27

    Eye Drops Recalled Due to Lack of Sterility Assurance

    TRP Natural Eyes sterile eye drops are being recalled because the manufacturer cannot assure the product maintains sterility. The recall involves 196,111 units distributed to retailers in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Dryness Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC:17312-178-15.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Food)·F-1521-2023·2023-09-27

    Honey Roasted Cashews Recalled for Undeclared Soy and Wheat Allergens

    Mount Franklin Foods is recalling three varieties of honey roasted cashews nationwide due to undeclared soy and wheat allergens caused by mislabeling.

    Product
    1. 7 Select Cashews Halves & Pieces Honey Roasted, Net Wt 3 oz, UPC 00052548723804 2. 7 Select Cashews Halves & Pieces Honey Roasted, Net Wt 5 oz, UPC 00052548723811 3. Circle K Honey Roasted Cashews, Net Wt 2 oz, UPC 194283102749
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2596-2023·2023-09-27

    Stryker ACM Bone Cement Mixer Nozzle May Break During Surgery

    Stryker ACM bone cement mixing system nozzles may break or disassemble during surgical use, causing loss of function and risk of material fragments in the surgical site. Users should stop using affected units.

    Product
    Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a constant high vacuum through the process. Catalog number: 0206-512-000.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2608-2023·2023-09-27

    Philips Patient Information Center iX Software Crashes Delay Patient Monitoring

    Philips Patient Information Center iX software versions 4.x may crash due to an Intel Graphics Driver error, causing a blank screen. Users must manually reboot the system, potentially delaying the detection of patient condition changes.

    Product
    Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) Patient Information Center iX Expand Product Number: 866390; (3) PIC iX Essentials Product Number: 867093; (4) PIC iX Essential
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2610-2023·2023-09-27

    TyTek Tension Pneumothorax Access Kit Recalled for Inadequate Placement Instructions

    Tytek Medical Inc is recalling the TyTek Tension Pneumothorax Access Kit (Model TM-303) because the instructions do not adequately identify the risks associated with needle decompression or clearly show proper placement site location.

    Product
    TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-303
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-1518-2023·2023-09-27

    Circle K Sweet & Spicy Mix recalled for undeclared soy and wheat allergens

    Mount Franklin Foods is recalling Circle K Sweet & Spicy Mix nationwide due to potential undeclared soy and wheat allergens caused by mislabeling. Consumers with soy or wheat allergies should not consume the product.

    Product
    Circle K Sweet & Spicy Mix, Net Wt 7 oz; UPC 194283104613
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·23293·2023-09-21

    H&M Men's Clasp Beaded Bracelets Recalled for High Lead Content

    H&M is recalling about 12,290 men's clasp beaded bracelets because the clasp contains lead levels exceeding the federal ban. Lead is toxic if ingested by young children and can cause adverse health effects.

    Product
    Men's clasp beaded bracelets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23291·2023-09-21

    DR Power Chipper Shredders Recalled Due to Laceration Hazard

    DR Power Chipper Shredders are being recalled because metal pieces can come loose and be ejected, or the hopper can detach, both creating laceration hazards. The firm has received 79 reports of parts coming loose and 3 reports of hopper detachment, with a total of 3 reported injuries.

    Product
    DR Power Chipper Shredders
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23793·2023-09-21

    Novaform ComfortGrande and DreamAway Mattresses Recalled for Mold Contamination

    FXI recalls about 48,000 Novaform mattresses from Costco due to mold contamination from water exposure during manufacturing. The mold poses a health risk to people with compromised immune systems or mold allergies. No injuries have been reported.

    Product
    Novaform ComfortGrande 14-inch and Novaform DreamAway 8-inch Mattresses
    Category
    Consumer Product
    Distribution
    Distributed nationwide