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.

14301–14325 of 53090

  • HighFDA (Drugs)·D-0277-2023·2023-02-22

    Caspofungin Injectable Medication Recalled for Sterility Assurance Issues

    Sentara Infusion Services is recalling Caspofungin 50mg injectable bags dispensed nationwide due to lack of sterility assurance. Patients should consult their healthcare provider.

    Product
    CASPOFUNGIN 50MG IN NS 100ML, used with a HOMEPUMP, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1130-2023·2023-02-22

    HydroPICC Catheter Recall Due to Incorrect Expiration Dates on Select Lots

    Select lots of HydroPICC 4Fr catheters are mislabeled with expiration dates that exceed their actual expiration. Affected units should not be used.

    Product
    HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0352-2023·2023-02-22

    Starbucks Vanilla Frappuccino Recalled for Potential Glass Contamination

    PepsiCo is recalling Starbucks Vanilla Frappuccino bottles nationwide due to potential glass contamination. Consumers should not consume affected bottles.

    Product
    Starbucks frappuccino Vanilla. Chilled Coffee Drink. 13.7 Fl Oz (405mL). UPC 0 12000-81331 3. Starbucks Coffee Company. For comments or questions, call 1-800-211-8307.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0293-2023·2023-02-22

    Fluconazole 200mg injection recalled due to sterility concerns

    Sentara Infusion Services is recalling Fluconazole 200mg injectable solution due to lack of sterility assurance. The recall affects 13 bags distributed nationwide to patients.

    Product
    FLUCONAZOLE 200MG NS 100ML, antifungal, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0327-2023·2023-02-22

    Abelcet Injectable Drug Recalled Due to Bacterial Contamination

    A sterile injectable drug, Abelcet, is being recalled due to bacterial contamination detected in a nationwide shipment. The recall affects 31,879 vials with lot number 1203A.

    Product
    Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN 46268; Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 57665-101-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0303-2023·2023-02-22

    Meropenem Injectable Antibiotic Recalled Due to Lack of Sterility Assurance

    Sentara Infusion Services is recalling 91 bags of meropenem injectable antibiotic due to lack of sterility assurance. The product was dispensed nationwide to patients.

    Product
    MEROPENEM (a) 1000MG IN NS 250ML, (b) 2GM IN NS 100ML, (c) 500mg IN NS 125ML, antibiotic, Rx Only, use with home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0323-2023·2023-02-22

    Vancomycin Intravenous Solution Recalled Due to Sterility Assurance Issue

    Sentara Infusion Services is recalling Vancomycin 700 MG and 1000 MG intravenous solution formulations due to lack of sterility assurance. Eighteen bags were distributed nationwide.

    Product
    VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1114-2023·2023-02-22

    Surgical Breast Biopsy Kits Recalled Due to Non-Sterile Outer Wrapping

    Medline Industries is recalling 60 units of its Breast Biopsy Kit nationwide because the outer wrapping is not sterile. Only the kit's contents maintain sterility.

    Product
    Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0285-2023·2023-02-22

    Intravenous hydration solution recalled for lack of sterility assurance

    Sentara Infusion Services is recalling D5W1/2NS W/ 77MEQ OF SOD ACETATE 1000ML intravenous hydration solution due to lack of sterility assurance. Eight bags were dispensed to patients nationwide.

    Product
    D5W1/2NS W/ 77MEQ OF SOD ACETATE 1000ML, Hydration, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1117-2023·2023-02-22

    Surgical convenience kits recalled due to sterile packaging failure

    Medline Industries is recalling 138 surgical convenience kits nationwide because the outer packaging does not maintain sterility. Only the contents inside the kit wrapper are sterile, creating a contamination risk.

    Product
    Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY, Reorder Number MNS9065
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0266-2023·2023-02-22

    Injectable drug vials recalled for particulate matter contamination

    McGuff Compounding Pharmacy Services is recalling Thiamine Hydrochloride and Riboflavin injection vials due to presence of foreign substances in some units.

    Product
    Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 2 mL Sterile Single Use Vial, Preservative-Free, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0276-2023·2023-02-22

    MicroPort Recalls Evolution MP Tibial Bases Due to Wrong Size in Packaging

    MicroPort Orthopedics is recalling lot 1916715 of EVOLUTION MP Tibial Bases (size 7) due to a packaging error where the wrong-sized implant component was found in a package. A confirmed incident involved discovery during surgery.

    Product
    EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1128-2023·2023-02-22

    Surgical Convenience Kits Recalled Due to Non-Sterile Outer Packaging

    Medline and Centurion Medical Products are recalling surgical convenience kits because the outer packaging has perforations that prevent sterility, leaving only the contents inside the kit wrapping sterile.

    Product
    Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850; b) MEDLINE SHOULDER SUSPENSION II-LF, Reorder Number DYNJSHOULDER2; c) MEDLINE TRAY BONE MARRO ASC LTX SAFE, Reorder Number P429589A; d) MEDLINE LUMBAR TRAY, Reorder Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0281-2023·2023-02-22

    Cefoxitin injectable bags recalled nationwide for sterility assurance failure

    Cefoxitin injectable antibiotic (1GM and 2GM) prepared by Sentara Infusion Services is being recalled nationwide due to lack of sterility assurance. Affected patients should contact their pharmacy immediately.

    Product
    CEFOXITIN (a) 1GM IN NS 50ML,(b) 2GM IN NS 100ML, used with a home pump. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0351-2023·2023-02-22

    El Tapatio Queso Fresco Cheese Recalled Due to Missing Ingredient Statement

    El Tapatio Queso Fresco cheese is being recalled because the product lacks a required ingredient statement on its packaging. This prevents consumers, especially those with food allergies, from identifying potential allergens.

    Product
    El Tapatio Queso Fresco, Mexican Style Crumbling Cheese. Item 5204. UPC 0 83846-10158 2. Net Wt. 10 oz. (283g). Keep Refrigerated. Manufacture for: La Hispamex Food Products, Inc., Cicero, IL 60804.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1113-2023·2023-02-22

    Neonatal PICC Surgical Kits Recalled for Non-Sterile External Packaging

    Medline Industries is recalling CENTURION MEDICAL PRODUCTS neonatal PICC surgical kits because the perforated bag fails to maintain sterility on the exterior packaging. Only contents inside are sterile.

    Product
    Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PICC TRAY, Reorder Number CVI4685
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V112000·2023-02-22

    Roadtrek Recreational Vehicle Cooktop Recall: Gas Leak Fire Risk

    Roadtrek is recalling certain 2021-2022 recreational vehicles equipped with SDS2 2-burner cooktops because internal burner tubes may fracture and leak gas, creating a fire hazard.

    Product
    ROADTREK — ROADTREK ZION SLUMBER, PLAY SLUMBER, ZION, ZION SRT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0324-2023·2023-02-22

    Vitamin K Injectable Syringes Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling Vitamin K (Phytonadione) 2.5mg injectable syringes distributed nationwide due to lack of sterility assurance. Patients should contact their healthcare provider.

    Product
    VITAMIN K(PHYTONADIONE) 2.5MG(0.25ML) SYRINGE, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0317-2023·2023-02-22

    Tobramycin 660mg Injectable Antibiotic Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling Tobramycin 660mg injectable antibiotic used for home infusion therapy due to lack of sterility assurance. Two bags were dispensed to patients nationwide.

    Product
    TOBRAMYCIN 660MG IN NS 66ML, antibiotic, Rx Only, use with homepump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1132-2023·2023-02-22

    Olympus colonovideoscope recalled for potential microbial contamination from veterinary use

    An Olympus EVIS EXERA III colonovideoscope was used in veterinary endoscopy before being designated as a medical facility loaner, creating potential for microbial contamination.

    Product
    EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0307-2023·2023-02-22

    FDA recalls Milrinone injectable medication due to lack of sterility assurance

    Sentara Infusion Services recalls 83 bags of Milrinone injectable medication nationwide due to lack of sterility assurance. Patients should contact their healthcare provider immediately.

    Product
    Milrinone (a) 104MG IN 0.45% NS 130ML,(b) 108MG IN 0.45% NS 135ML, (c) 120MG IN 0.45% NS 150ML, (d) 136MG IN 0.45% NS 170ML, (e) 144MG IN 0.45% NS 180ML, (f) 160MG IN 0.45% NS 200ML, (g) 168MG IN 0.45% NS 210ML, (h) 192MG IN 0.45% NS 240ML, (i) 44MG IN 0.45% NS 55 ML, (j) 52MG…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0280-2023·2023-02-22

    Cefepime injectable antibiotic bags recalled due to sterility concerns

    Sentara Infusion Services is recalling 71 bags of Cefepime injectable antibiotic due to lack of sterility assurance. Patients who received affected doses should consult their healthcare provider.

    Product
    CEFEPIME, (a) 2GM IN NS 100ML (b)8GM IN NS 400ML (c) 12GM IN NS 600ML, used with a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0287-2023·2023-02-22

    Daptomycin Injectable Antibiotic Recalled Due to Sterility Assurance Failure

    Sentara Infusion Services is recalling daptomycin injectable antibiotic bags due to lack of sterility assurance. The 17 affected bags were dispensed nationwide and pose a potential infection risk.

    Product
    DAPTOMYCIN (a) 400MG IN NS 20ML, (b) 550MG IN NS 27.5ML, antibiotic, Rx only, used with a home pump. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·23V107000·2023-02-21

    Par Nado Recalls Alto Travel Trailers Due to Gas Leak Risk

    Par Nado is recalling 2021-2024 Alto travel trailers because burner tubes may fracture, causing a gas leak that could lead to fire.

    Product
    SAFARI CONDO — SAFARI CONDO ALTO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V108000·2023-02-21

    2023 Infiniti QX60 Second-Row Seat May Fail to Lock Properly

    The second-row adjustable seat may extend past its stopper and fail to lock in certain 2023 Infiniti QX60 vehicles. This defect could prevent proper occupant restraint during a crash, increasing injury risk.

    Product
    INFINITI — INFINITI QX60
    Category
    Vehicle
    Distribution
    Distributed nationwide