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.

11276–11300 of 53044

  • HighFDA (Drugs)·D-0064-2024·2023-10-25

    Compounded Intranasal Lidocaine-Oxymetazoline Solution Recalled Due to Sterility Assurance

    Pine Pharmaceuticals is recalling 860 syringes of intranasal lidocaine-oxymetazoline solution distributed nationwide due to lack of sterility assurance. Lot 67808 expired 10/23/2023.

    Product
    Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0065-2024·2023-10-25

    Foscarnet Sodium Injectable Recalled Due to Lack of Sterility Assurance

    Pine Pharmaceuticals is recalling Foscarnet Sodium 2.4mg/0.1 mL injectable syringes nationwide due to lack of assurance of sterility. No illnesses or injuries have been reported.

    Product
    Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0053-2024·2023-10-25

    Calcium Gluconate Ophthalmic Irrigation Solution Recall Due to Sterility Concerns

    Pine Pharmaceuticals is recalling Calcium Gluconate Ophthalmic Irrigation Solution 1% (Lot #69802) due to lack of sterility assurance. The 128 bags distributed nationwide may pose infection risk if used.

    Product
    Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0125-2024·2023-10-25

    Wrist and Thumb Orthosis Recalled for Undeclared Latex

    North Coast Medical Inc is recalling the Gladiator Wrist & Thumb Orthosis because the thumb strap may contain latex that is not declared on the product label. People with latex allergies are at risk.

    Product
    Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654 (Large/Left), NC86655 (Large/Right), NC86656 (X-Large/Left), and NC86657 (X-Large/Right)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Drugs)·D-0057-2024·2023-10-25

    Cefuroxime Injectable Syringes Recalled for Lack of Sterility Assurance

    Pine Pharmaceuticals is recalling 4,972 syringes of Cefuroxime injectable medication due to lack of assurance of sterility. The compounded antibiotic was distributed nationwide.

    Product
    Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0116-2024·2023-10-25

    DeRoyal Head and Neck Surgical Kits Recalled for Damaged Syringe Luer Tip

    DeRoyal Industries is recalling 32 surgical procedure kits containing syringes with potentially damaged luer tips that could compromise the sterile packaging barrier. The kits were distributed in Pennsylvania.

    Product
    DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0050-2024·2023-10-25

    Compounded Bevacizumab Injectable Syringes Recalled for Sterility Assurance

    Pine Pharmaceuticals is recalling approximately 2,862 syringes of compounded Bevacizumab 1.25 MG/0.05 ML Solution for Injection due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0295-2024·2023-10-25

    Safeway Recalls Diced Organic Butternut Squash for E. Coli O45

    Safeway Fresh Foods is recalling 32-oz. Diced Organic Butternut Squash distributed exclusively to Costco in Washington DC, Maryland, Pennsylvania, and Virginia due to potential E. coli O45 contamination.

    Product
    Sunnyside Farms, diced Organic Butternut Squash , 32-oz. , plastic tray, 6 trays per case, Perishable Keep Refrigerated .
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0115-2024·2023-10-25

    HydroPICC Catheter Kit Recalled for Missing Safety Warnings

    Access Vascular recalls HydroPICC 5Fr Dual Lumen Maximal Barrier Kits due to incorrect Instructions For Use missing warnings about adult-use only and vessel sizing risks. No adverse events reported.

    Product
    HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0122-2024·2023-10-25

    Functional MRI Software Bug May Cause DICOM Export Data Mismatch

    A software bug in Functional MR V1.0 can cause file contents and descriptions to not match when exporting multiple regions of interest in DICOM format, potentially leading to misinterpretation of clinical imaging data.

    Product
    Functional MR V1.0
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0058-2024·2023-10-25

    FDA Recalls Compounded Moxifloxacin Syringes for Lack of Sterility Assurance

    Pine Pharmaceuticals recalls 2,176 syringes of compounded moxifloxacin nationwide due to inadequate sterility assurance. The product was distributed to healthcare providers and patients.

    Product
    Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0054-2024·2023-10-25

    Calcium Gluconate Inhalation Solution Recalled Due to Sterility Concerns

    Pine Pharmaceuticals is recalling Calcium Gluconate 2.5% inhalation solution due to lack of sterility assurance. Patients should stop using affected syringes and contact their healthcare provider.

    Product
    Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0114-2024·2023-10-25

    HydroPICC Catheter Kit Recall: Missing Critical Use-Restriction Warnings

    Access Vascular is recalling HydroPICC Dual Lumen Catheter kits with incorrect instruction documents that omit critical warnings about adult-only use and vessel sizing. No adverse events have been reported.

    Product
    HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0059-2024·2023-10-25

    Compounded Lidocaine-Phenylephrine Injectable Recalled Due to Sterility Assurance Issues

    Pine Pharmaceuticals is recalling 9,673 vials of compounded lidocaine-phenylephrine injectable due to lack of assurance of sterility. Affected lots were distributed nationwide.

    Product
    Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0051-2024·2023-10-25

    Vancomycin Intraocular Injection Recalled Due to Sterility Assurance Failure

    Pine Pharmaceuticals is recalling 26 vials of Vancomycin 1 MG/0.1 ML intraocular injection (Lot #69985) due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0055-2024·2023-10-25

    FDA Recalls Compounded Ophthalmic Solution Due to Sterility Concerns

    Pine Pharmaceuticals recalls Tropi-Phen ophthalmic solution due to lack of sterility assurance. The 15 mL droppers were distributed nationwide and customers should not use affected lots.

    Product
    Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0294-2024·2023-10-25

    Mint chip ice cream recalled for undeclared wheat, soy, and coconut

    Katie's Korner Inc. is recalling 35 units of 3-gallon mint chip ice cream due to undeclared wheat, soy, and coconut. Consumers with allergies to these ingredients should not consume the product.

    Product
    3 Gallon, plastic container of mint chip flavored ice cream
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0061-2024·2023-10-25

    Calcium Chloride IV Solution Recalled Due to Sterility Assurance Concerns

    Pine Pharmaceuticals recalls Calcium Chloride IV Solution for Intravenous Injection, 20 mg/mL (lot 70101), due to lack of assurance of sterility. Approximately 130 units were distributed nationwide.

    Product
    Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0297-2024·2023-10-25

    Sweet Corn Pancakes recalled for undeclared wheat, soy, and yellow #5 allergens

    Tama Corporation recalls PAISA Sweet Corn Pancakes for undeclared wheat, soy, and yellow #5 allergens. Consumers with allergies to these substances should not consume the product.

    Product
    PAISA Sweet Corn Pancakes, Cachapas de Maiz, NET WT. 24 Oz., 5 units, KEEP REFRIGERATED
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0286-2024·2023-10-25

    Sweet Potatoes Recalled Due to Processing Equipment Failure

    Moody Dunbar Inc recalls HEB and Sysco brand sweet potatoes because a sterilization monitoring chart malfunctioned during production, preventing verification of adequate heat treatment.

    Product
    Sweet Potatoes sold under the brand names: HEB CUT SWEET POTATOES IN LIGHT SYRUP NET WT. 29 OZ (1 LB 13 OZ) 822g MADE WITH PRIDE AND CARE FOR HEB, SAN ANTONIO, TEXAS 78204 UPC 0 41220 45933 9 & SYSCO Classic Cut Sweet Potatoes NET WT/PESO NETO 108 OZ (6 LB 12 OZ) 3.06 kg…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0113-2024·2023-10-25

    Stryker Tornier Reversed Glenoid Baseplate Recalled for Manufacturing Defect

    One lot of Stryker Tornier Perform Reversed Glenoid Baseplate components was manufactured with incorrect 6mm spacers instead of 3mm, preventing proper assembly. The defect affects 30 units distributed across ten US states.

    Product
    stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0112-2024·2023-10-25

    Monoject tuberculin syringes incompatible with certain IV connectors

    Cardinal Health is recalling Monoject tuberculin syringes because the conical tip is incompatible with certain needleless IV connectors.

    Product
    Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0056-2024·2023-10-25

    Intraocular Moxifloxacin Injection Recalled Due to Sterility Assurance Issues

    Pine Pharmaceuticals is recalling 2,484 syringes of Moxifloxacin intraocular injection nationwide due to lack of sterility assurance in the compounded product.

    Product
    Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0296-2024·2023-10-25

    Kraft Singles American Cheese Recalled for Plastic Film Fragment Risk

    Heinz is recalling Kraft Singles American Cheese because thin plastic film fragments may remain on cheese slices after unwrapping. Affected product was distributed nationwide and in Puerto Rico.

    Product
    Kraft Singles American Pasteurized Prepared Cheese product, 24 individually wrapped slices in flexible film per pack, net wt. per pack 16oz, keep refrigerated. Single pack is sold at retail. Case UPC 0 00 2100007180 7; Single Pack UPC 0 2100061526 1: Each case contains 27…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·23V715000·2023-10-25

    Porsche 911 GT3 air bag control unit may deploy unnecessarily in crash

    Porsche is recalling certain 2021-2024 911 models equipped with optional full bucket seats due to a potential air bag control defect. Unnecessary air bag deployment during a crash could increase injury risk.

    Product
    PORSCHE — PORSCHE 911 GT3, 911 TURBO, 911 TURBO S, 911 GT3 RS
    Category
    Vehicle
    Distribution
    Distributed nationwide