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.

13201–13225 of 53086

  • HighFDA (Devices)·Z-1580-2023·2023-05-24

    Breathing circuit swivel elbow recalled for inadequate sterilization instructions

    Smiths Medical is recalling DuraLife Swivel Elbow breathing circuit devices due to inadequate sterilization instructions. The device instructions lack cleaning methods, autoclave cycle duration, and reuse specifications.

    Product
    DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0630-2023·2023-05-24

    Piperacillin and Tazobactam Injection Recalled Due to Sterility Assurance Issue

    Approximately 936,680 vials of Piperacillin and Tazobactam for Injection are being recalled nationwide due to lack of assurance of sterility. All affected lots remain within their expiration dates.

    Product
    Piperacillin and Tazobactam for Injection, UPS, 3.375 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-079-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0625-2023·2023-05-24

    Piperacillin and Tazobactam Injection Recalled for Sterility Assurance Failure

    Meitheal Pharmaceuticals is recalling Piperacillin and Tazobactam for Injection due to lack of sterility assurance. The recalled product may pose an infection risk to patients if used.

    Product
    Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-004-51
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0579-2023·2023-05-24

    Heparin Sodium and Dextrose Injection Recalled Due to Subpotency

    B. Braun Medical Inc. is recalling 1,380 units of Heparin Sodium in Dextrose injection because the product is subpotent with lower anti-factor IIa potency than specified.

    Product
    HEPARIN SODIUM IN DEXTROSE — HEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0601-2023·2023-05-24

    Ampicillin and Sulbactam Injectable Recalled for Sterility Assurance Defect

    The FDA has recalled Ampicillin and Sulbactam for Injection due to lack of assured sterility. Approximately 119,340 vials distributed nationwide within the United States are affected.

    Product
    Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-081-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0580-2023·2023-05-24

    Ampicillin for Injection Recall Due to Sterility Assurance Concerns

    Astral SteriTech is recalling 70,040 vials of Ampicillin for Injection nationwide due to lack of assurance of sterility in the manufacturing process.

    Product
    Ampicillin for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-220-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0627-2023·2023-05-24

    Piperacillin and Tazobactam Injection Recalled for Lack of Sterility Assurance

    Astral SteriTech recalls 223,590 vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assured sterility. Patients and healthcare providers should stop use and consult their provider.

    Product
    Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-217-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1585-2023·2023-05-24

    Philips Incisive CT system foot switch poses entrapment risk during unload

    The Philips Incisive CT system's foot switch may trap the operator's foot during the unload function, causing injury. The FDA has issued a Class II recall affecting 46 units worldwide.

    Product
    Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0619-2023·2023-05-24

    Injectable Ceftriaxone Recalled for Lack of Sterility Assurance

    Astral SteriTech is recalling 243,825 vials of Ceftriaxone for Injection due to inability to assure sterility. The medication was distributed nationwide and poses a contamination risk.

    Product
    Ceftriaxone for Injection, USP, 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-097-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1599-2023·2023-05-24

    Urine Analysis Diagnostic Device Software Issue Prevents Carryover Detection

    Beckman Coulter is recalling UA WIN 10 diagnostic kits because an optional software flag for detecting sample carryover was enabled but not displayed, preventing proper investigation of potential test contamination.

    Product
    UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0894-2023·2023-05-24

    Trader Joe's Genova Pesto Recalled for Undisclosed Milk and Walnut Allergens

    Trader Joe's Genova Pesto is recalled due to labeling error: the product contains milk and walnuts but the label does not disclose these allergens. Affected product was distributed in Arizona, California, Florida, and Washington.

    Product
    Top Label: TRADER JOE'S GENOVA PESTO NET WT. 7 OZ. (198g) Side Label: TRADER JOE'S HUMMUS DIP NET WT. 7 OZ (98g) CONTAINS: SESAME. DIST. & SOLD EXCLUSIVELY BY: TRADER JOE'S, MONROVIA, CA 91016 UPC 0015 7353
    Category
    Food
    Distribution
    4 states
  • HighFDA (Drugs)·D-0642-2023·2023-05-24

    Vancomycin Injectable Solution Recalled Due to Lack of Sterility Assurance

    Apollo Care, LLC is recalling 413 bags of Vancomycin 2g injectable solution (Lot #AC-016638, expiration 05/27/2023) distributed in Missouri due to lack of assurance of sterility.

    Product
    VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-204-50
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0616-2023·2023-05-24

    Ceftriaxone Injectable Antibiotic Recalled Nationwide for Sterility Assurance Deficiency

    Astral SteriTech's 66,125-vial ceftriaxone injection is being recalled nationwide due to lack of assurance of sterility in manufacturing. The product is distributed across the United States.

    Product
    Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-094-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0624-2023·2023-05-24

    Piperacillin and Tazobactam for Injection Recalled Due to Sterility Assurance Failure

    Astral SteriTech recalls approximately 893,950 vials of piperacillin and tazobactam injection nationwide because the manufacturer cannot assure the product was properly sterilized.

    Product
    Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-003-31
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0611-2023·2023-05-24

    Ceftriaxone injection vials recalled for lack of sterility assurance

    Astral SteriTech is recalling approximately 66,250 vials of Ceftriaxone for Injection due to lack of sterility assurance. The injectable antibiotic poses a potential contamination risk if used.

    Product
    Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-211-42
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0639-2023·2023-05-24

    Injectable Vancomycin Recalled Due to Lack of Sterility Assurance

    Apollo Care LLC is recalling 1,113 bags of VANComycin injectable solution due to lack of assurance of sterility. The recalled product was distributed in Missouri.

    Product
    VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-264-25
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-0891-2023·2023-05-24

    Duke's Bayou Remoulade Sauce Mislabeled as Gluten-Free Despite Wheat Content

    Duke's Southern Sauces Bayou Remoulade sauce is mislabeled as gluten-free but contains wheat in its soy sauce ingredient. Consumers relying on the false gluten-free label could be harmed.

    Product
    Duke's SOUTHERN SAUCES BAYOU REMOULADE NET WT. 10 FL OZ (296 ml) GLUTEN FREE INGREDIENTS:***SOY SAUCE (WHEAT, SOYBEANS, AND SALT)***CONTAINS SOY, WHEAT, EGGS SAUER BRANDS, INC. RICHMOND, VA 23220 UPC x 52500 08582 7
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0596-2023·2023-05-24

    Ampicillin and Sulbactam for Injection Recalled Due to Sterility Concerns

    Ampicillin and Sulbactam for Injection is being recalled nationwide due to lack of assurance of sterility. Approximately 58,770 vials manufactured by Astral SteriTech Private Ltd. are affected.

    Product
    Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-241-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1581-2023·2023-05-24

    DuraLife Breathing Circuit Extension Tube Recall Due to Inadequate Sterilization Instructions

    Smiths Medical is recalling 2,101 DuraLife Autoclavable Silicone Extension Tubes due to inadequate sterilization instructions. The product documentation does not specify cleaning methods, autoclave cycle duration, or the number of reuse cycles allowed per patient.

    Product
    DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing circuits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0638-2023·2023-05-24

    Vancomycin Injectable Drug Recalled Due to Lack of Sterility Assurance

    Apollo Care, LLC is recalling 1,113 bags of Vancomycin 1.25g injection in 250 mL of 0.9% Sodium Chloride solution due to lack of assurance of sterility. The recall affects product distributed in Missouri.

    Product
    VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-284-25
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0606-2023·2023-05-24

    Cefepime for Injection Recalled Due to Sterility Assurance Concerns

    The FDA is recalling Cefepime for Injection 2 grams per vial due to inability to assure product sterility. No illnesses have been reported.

    Product
    Cefepime for Injection, USP 2 grams per vial, Rx only, Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-009-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0589-2023·2023-05-24

    Ampicillin Injection Recalled for Lack of Sterility Assurance

    Astral SteriTech has recalled approximately 7,214 bottles of Ampicillin for Injection due to lack of assurance of sterility. The product was distributed nationwide within the United States.

    Product
    Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-088-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0643-2023·2023-05-24

    VANComycin Injectable Recalled for Lack of Sterility Assurance

    Apollo Care, LLC is recalling a VANComycin injectable medication due to lack of assurance of sterility. The affected lot was distributed in Missouri only.

    Product
    VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-224-50
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0621-2023·2023-05-24

    Piperacillin and Tazobactam for Injection Recalled for Lack of Sterility Assurance

    Astral SteriTech is recalling approximately 1.3 million vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility during manufacturing.

    Product
    Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-576-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·23V365000·2023-05-24

    Loose Seat Belt Attachment in Winnebago and Itasca Motorhomes

    Winnebago and Itasca recall certain 2020-2023 motorhomes due to improperly tightened seat belt attachments that may fail to restrain occupants in a crash. Dealers will tighten fasteners free of charge.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA INSPIRE, ADVENTURER, VISTA, SHELL
    Category
    Vehicle
    Distribution
    Distributed nationwide