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.

14226–14250 of 53090

  • HighFDA (Devices)·Z-1136-2023·2023-02-22

    Siemens Biograph Vision PET Scanner Gantry Locking Mechanism Recall

    Siemens recalls Biograph Vision PET scanners worldwide for a potential defect in the gantry locking mechanism that secures the equipment during scanning and service.

    Product
    SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0306-2023·2023-02-22

    Metronidazole injectable antibiotic recalled due to sterility concerns

    Sentara Infusion Services is recalling 30 bags of Metronidazole 500mg injectable antibiotic distributed nationwide due to lack of sterility assurance. Patients using the product should contact their healthcare provider.

    Product
    METRONIDAZOLE 500MG 100ML, antibiotic, Rx Only, use with a 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-0298-2023·2023-02-22

    INTRALIPID 18GM Parenteral Nutrition Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling 7 bags of INTRALIPID 18GM, a parenteral nutrition solution, due to lack of sterility assurance. The product was dispensed to patients nationwide.

    Product
    INTRALIPID 18GM, TPN, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0275-2023·2023-02-22

    Ampicillin IV Infusion Bags Recalled for Lack of Sterility Assurance

    Sentara Home Infusion Pharmacy Services is recalling 14 bags of Ampicillin 8GM in NS 400ML due to lack of sterility assurance. The affected batches were distributed nationwide to patients.

    Product
    AMPICILLIN 8GM IN NS 400ML, antibiotic, used with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0309-2023·2023-02-22

    Mycamine 100mg Intravenous Preparation Recalled for Sterility Assurance Deficiency

    Sentara Infusion Services recalled Mycamine 100mg intravenous solution nationwide due to lack of sterility assurance. Patients should contact their healthcare provider.

    Product
    MYCAMINE 100MG IN NS 100ML, antifungal, Rx Only, use with a homepump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1126-2023·2023-02-22

    Surgical Instrument Trays Recalled for Compromised Outer Bag Sterility

    Medline Industries recalls CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAYS due to a perforated outer bag that fails to maintain sterility. While the inner contents remain sterile, the compromised outer bag could contaminate instruments during surgical procedures.

    Product
    Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAY, Reorder Number SUT10675
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1118-2023·2023-02-22

    Surgical Convenience Kits Recalled Due to Compromised Sterility of External Wrapping

    Medline Industries is recalling 630 surgical convenience kits because the perforated bag design fails to maintain sterility of the outer wrapping, though internal contents remain sterile.

    Product
    Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number DYNDA2524 b) CENTURION MEDICAL PRODUCTS DIALYSIS ON/OFF BUNDLE, Reorder Number DT22705A c) CENTURION MEDICAL PRODUCTS ULTRASOUND PIV BUNDLE, Reorder Number IV8635D d) CENTURION MEDICAL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1119-2023·2023-02-22

    Surgical kits recalled due to compromised sterile wrapping

    Medline Industries is recalling multiple CENTURION MEDICAL PRODUCTS surgical kits because perforated packaging compromises the sterile barrier. Only contents inside the kit wrapping maintain sterility.

    Product
    Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, Reorder Number CVI2105; b) CENTURION MEDICAL PRODUCTS VASECTOMY KIT, Reorder Number MNS11975; c) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT11670; d)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0267-2023·2023-02-22

    Injectable Vitamin B Vials Recalled for Particulate Matter Contamination

    McGuff Compounding Pharmacy recalls 255 vials of thiamine and riboflavin injection nationwide due to foreign substances found in some vials.

    Product
    Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 30 mL Sterile Multiple Use Vial, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Services, Inc…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0297-2023·2023-02-22

    Antibiotic Injectable Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling an antibiotic injectable medication due to lack of sterility assurance. Seven bags were dispensed to patients nationwide with a Beyond Use Date of December 2022.

    Product
    IMIPENEM/CILASTATIN 2000MG IN NS 400ML, antibiotic, Rx Only, use with a Curlin Pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 63323-0322-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0273-2023·2023-02-22

    Amikacin Injectable Antibiotic Lacks Sterility Assurance, Nationwide Recall

    Sentara Infusion Services is recalling 7 bags of Amikacin 450MG injectable antibiotic due to lack of sterility assurance. The product was dispensed nationwide to patients receiving IV infusions.

    Product
    Amikacin 450MG IN NS 45ML, Antibiotic, used in a HOMEPUMP, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300 Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0315-2023·2023-02-22

    Piperacillin/Tazobactam Injectable Antibiotic Recalled Due to Lack of Sterility Assurance

    Sentara Infusion Services is recalling Piperacillin/Tazobactam antibiotic injections due to lack of sterility assurance. The 78-unit recall affects patients nationwide.

    Product
    PIPERACILLIN / TAZOBACTAM (a) 4.5GM IN NS 100 ML, (b)18GM IN NS 267M, (c) 27GM IN NS 400ML, (d) 3.375 GM IN NS 50ML, (e) 36 GM IN NS 533 ML, antibiotic, Rx only, use with a Curlin or home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0294-2023·2023-02-22

    Ganciclovir Injectable Solution Recalled Due to Lack of Sterility Assurance

    Sentara Infusion Services is recalling Ganciclovir (Cytovene) injectable solutions due to lack of sterility assurance. The medication was dispensed to patients nationwide.

    Product
    GANCICLOVIR ( CYTOVENE) (a)1480MG IN NS 296ML, (b) 740 MG IN NS 336 ML, antiviral, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0277-2023·2023-02-22

    Orthopedic Implant Bolts Recalled Due to Breakage Risk in Bone Correction

    OrthoPediatrics has recalled Orthex Large Bone Shoulder Bolts due to breakage risk that may disrupt bone correction and healing. Affected units were distributed in the United States and internationally.

    Product
    Orthex Large Bone Shoulder Bolt, model no. AS-17
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1112-2023·2023-02-22

    Medline CABG surgical convenience kits recalled due to sterility issue

    Medline is recalling 80 units of MEDLINE CABG PACK surgical convenience kits (Lot #22HMH432) nationwide because the perforated bag design cannot maintain sterility of the outer packaging wrapping.

    Product
    Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA2827
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0291-2023·2023-02-22

    Ertapenem Injectable Antibiotic Bags Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling 22 bags of Ertapenem (Invanz) injectable antibiotic due to lack of sterility assurance. The product was dispensed nationwide to patients receiving home infusion therapy.

    Product
    Ertapenem (Invanz) 1GM NS 100ML, antibiotic, use with home pump, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1122-2023·2023-02-22

    Medline Surgical Shoulder Suspension Kits Recalled for Sterility Compromise

    Medline is recalling 1,280 SHOULDER SUSPENSION surgical kits nationwide due to a defective perforated bag that fails to maintain sterility on the kit's exterior, potentially compromising the sterile contents inside.

    Product
    Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reorder Number DYNJSHOULDER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0299-2023·2023-02-22

    KYTRIL Antiemetic Syringes Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling KYTRIL 350mcg syringes distributed nationwide due to lack of sterility assurance. Patients who received affected units should contact their healthcare provider.

    Product
    KYTRIL 350MCG IN 3.5ML NS SYRINGE, antimetic, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0354-2023·2023-02-22

    Ube Cheesecake Recalled for Undeclared Coconut Allergen

    Hood Famous Bake Shop is recalling Ube Cheesecake products because coconut is listed in ingredients but not declared in the allergen statement, posing a risk to consumers allergic to coconut.

    Product
    Ube (Purple Yam) Cheesecake Coconut Butter Biscuit Crust (4oz) - UPC 6 60845 37067 8. Ube (Purple Yam) Cheesecake Coconut Butter Biscuit Crust (2 lbs.) - UPC 6 60845 37068 5
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1111-2023·2023-02-22

    Medline surgical convenience kits recalled for inadequate exterior sterility

    Medline is recalling surgical convenience kits because the perforated bag does not maintain sterility of the kit's exterior wrapping. Only the contents inside the wrapping are sterile.

    Product
    Surgical convenience kits labeled as: MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0272-2023·2023-02-22

    FDA Recalls 0.9% Sodium Chloride Solution for Lack of Sterility Assurance

    Sentara Infusion Services is recalling 114 bags of 0.9% Sodium Chloride intravenous solution due to lack of sterility assurance. The product was distributed nationwide with Beyond Use dates of December 24–31, 2022.

    Product
    0.9% Sodium Chloride, used as a diluent or hydration, packaged volume of (a)1000ML (b)2000ML (c) 720ML, used with Curlin pump, no pump or gravity. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1133-2023·2023-02-22

    iTotal Identity Impactor Handle surgical screws may loosen during procedures

    Conformis Inc. is recalling the iTotal Identity Impactor Handle due to potential loose screws that could fall into patients during surgical procedures. Approximately 70 units from lot D221301 were distributed across multiple U.S. states.

    Product
    iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0308-2023·2023-02-22

    Morphine Sulfate Intravenous Solutions Recalled Due to Sterility Assurance Failure

    Sentara Infusion Services is recalling Morphine Sulfate intravenous infusion solutions (1 mg/mL and 5 mg/mL) distributed nationwide due to lack of sterility assurance. The products may not be sterile, creating a potential risk of infection.

    Product
    MORPHINE Sulfate (a) 1MG/ML IN NS 350ML, (b) 5MG/ML IN NS 200ML, pain, Rx Only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0319-2023·2023-02-22

    FDA Class II: TPN solution bags lack sterility assurance

    Sentara Infusion Services is recalling 111 bags of TPN (Total Parenteral Nutrition) solution due to lack of sterility assurance. Products were dispensed nationwide to patients.

    Product
    TPN 107gm/AA, 200gm/DEX, 50gm/LIP 2250mL, (b) 108GM/AA, 330GM/DEX 3000ML, (c) 108GM/AA, 330GM/DEX, 60GM/LIP 3000ML, (d) 37GM/AA, 160GM/DEX 1450ML, (e) 37GM/AA, 160GM/DEX, 25GM/LIP 1450ML, (f) 74-100GM OF PROTEIN B4197 74 Gm, (g) 75GM/AA, 200GM/DEX, 43GM/LIP 2500ML, (h) 90GM/AA…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0311-2023·2023-02-22

    Nalbuphine Syringes Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling 31 nalbuphine syringes (1.5mg and 2.5mg) dispensed nationwide due to lack of sterility assurance. Patients should contact their healthcare provider.

    Product
    NALBUPHINE (a) 1.5MG IN 1.5ML NS, (b) 2.5MG IN 2.5ML NS, SYRINGE, pain, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide