The Recall Desk

State

Montana product recalls

20,308 recalls have nationwide distribution and so reach Montana. 0 additional recalls listed Montana specifically in their distribution scope.

About recalls in Montana

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Montana consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

12001–12025 of 20308

  • SevereFDA (Devices)·Z-2281-2023·2023-08-09

    Impella RP Flex cardiac pump recalled for thrombus formation risk

    The Impella RP Flex cardiac pump has been recalled due to a higher-than-expected rate of blood clot formation. Blood clots may reduce cardiac support or cause hemolysis.

    Product
    Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1026-2023·2023-08-09

    IV Transplant Solution Recalled Due to Inadequate Sterilization Validation

    Central Admixture Pharmacy Services is recalling 12 IV bags of Transplant Solution nationwide (Lot 36-252141) because the sterilization decontamination cycles lack proper validation, creating a sterility assurance deficiency.

    Product
    TRANSPLANT SOLUTION, Plasma-Lyte A - 75 ml, MSA/MSG 0.92 Molar -60 ml, dextrose 70% 21.3 ml; IV Bag, Total Volume = 165 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0014-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2258-2023·2023-08-09

    Philips CT scanner heat exchanger box may detach and cause injury

    The metal mounting box on the rotating scanner of the Incisive CT system may become detached and contact other components, potentially injuring users or causing system shutdown.

    Product
    Incisive CT-Computed Tomography X-Ray System Model: 728143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1052-2023·2023-08-09

    FDA Recalls Hydromorphone Injectable Solution Due to Sterility Validation Failure

    The FDA has recalled 3,824 bags of hydromorphone injectable solution due to lack of validated sterilization processes. The affected product may not meet required sterility assurance standards.

    Product
    HYDROmorphone added to 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 100 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2300-2023·2023-08-09

    Medline Procedural Kits Recalled for Potential Sterility Defect in Ultrasound Gel

    Medline Industries is recalling custom procedural kits because the ultrasound gel component may not meet sterility specifications. The kits were distributed nationwide and internationally from 2020 to 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. AAA PACK, Model Number: DYNJ44847I; b. ABDOMINAL VASCULAR PACK, Model Number: DYNJ82578; c. ABDOMINAL VASCULAR-LF, Model Numbers: DYNJ905291B, DYNJ905291C; d.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0999-2023·2023-08-09

    Neonatal TPN Starter Bags Recalled for Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 84 bags of neonatal TPN starter bags due to lack of sterility assurance and missing validation data for decontamination cycles.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0405-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2335-2023·2023-08-09

    Custom Sterile Procedural Kits Recalled for Potential Sterility Specification Failure

    Medline is recalling 6,340 custom sterile and non-sterile procedural kits because the ultrasound gel component may not meet sterility specifications, creating contamination risk in surgical applications.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CUSTOM GYN, Model Number: DYNJ63257C; b. GYN EXP LAPAROTOMY, Model Number: DYNJ906578C; c. INTRAUTERINE TRNSFUSION -LF, Model Number: DYNJ9048708I; d.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1029-2023·2023-08-09

    Cardioplegia Solution Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 144 bags of Cardioplegia Solution nationwide because validation data for sterilization cycles is lacking.

    Product
    CARDIOPLEGIA SOLUTION, 106 mEq K, Modified St. Thomas Solution High Potassium High Sodium Bicarbonate, IV Bag, Total Volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0204-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2259-2023·2023-08-09

    Incisive CT Computed Tomography System: Metal Mounting Box May Detach

    A metal mounting box in the Incisive CT scanner may become expelled, potentially injuring users or causing the system to shut down. Philips is recalling 20 affected units distributed internationally.

    Product
    Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2279-2023·2023-08-09

    Image intensifier detachment hazard in OEC fluoroscopy imaging systems

    GE OEC field upgrade kits for fluoroscopy systems may have image intensifiers that detach during movement, potentially falling and causing injuries.

    Product
    Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800, OEC 9800, and OEC 9900 Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2327-2023·2023-08-09

    Procedural Kits with Ultrasound Gel May Not Meet Sterility Specifications

    Medline Industries is recalling 144 custom procedural kits containing Turkuaz Ultrasound Gel because the sterile gel component may not meet required sterility specifications.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-FLAP HARVEST PACK, Model Number: DYNJ58575C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0975-2023·2023-08-09

    FDA Recalls oxyTOCIN IV Bags Over Sterility Assurance Failure

    FDA recalled 751 bags of oxyTOCIN added to Lactated Ringer's IV solution nationwide due to lack of validation data for decontamination cycles, which left sterility assurance unconfirmed.

    Product
    oxyTOCIN 15 units added to Lactated Ringer's 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC:72196-6037-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1050-2023·2023-08-09

    Fentanyl Injectable Solution Recalled for Unvalidated Sterilization Cycles

    Central Admixture Pharmacy Services is recalling 848 bags of fentanyl injection nationwide due to lack of validated sterilization processes that assure product sterility. Multiple lots distributed to healthcare facilities are affected.

    Product
    fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1033-2023·2023-08-09

    Cardioplegia Solution Recalled Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services has recalled 80 bags of Cardioplegia Solution (NDC 72196-0210-1) distributed nationwide due to lack of sterility assurance and insufficient validation data for decontamination cycles.

    Product
    CARDIOPLEGIA SOLUTION, 70 mEq K, Modified St. Thomas Formula low potassium, IV Bag, Total Volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0210-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0985-2023·2023-08-09

    Neonatal TPN Starter Bags Recalled Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services recalls 128 neonatal TPN starter bags distributed nationwide due to lacking validation of decontamination procedures, creating inability to assure product sterility.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0400-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1006-2023·2023-08-09

    Neonatal TPN Starter Bags Recalled Over Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling 108 Neonatal TPN Starter Bags (Lot 36-256338) due to lack of assurance of sterility and insufficient validation data for decontamination cycles.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0406-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1065-2023·2023-08-09

    Morphine Injectable Syringes Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 720 syringes of morphine due to lack of validation data for sanitization cycles, which creates uncertainty about product sterility. The product was distributed nationwide.

    Product
    morphine in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2040-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1073-2023·2023-08-09

    ePHEDrine Injectable Syringes Recalled Over Sterility Assurance Gaps

    Central Admixture Pharmacy Services is recalling 8,942 ePHEDrine syringes nationwide due to lack of validation data for sterilization procedures, creating a potential sterility risk for injectable medications.

    Product
    ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2267-2023·2023-08-09

    Olympus SPiN Drive Triple Needle Brush Recalled for Sensor Malfunction

    Olympus Corporation recalls the Always-On Tip Tracked Triple Needle Brush due to electromagnetic sensor tracking malfunction that impairs navigation functionality during endobronchial procedures, potentially causing procedural delays.

    Product
    Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2282-2023·2023-08-09

    Covidien Cytosponge Cell Collection Device Recall Due to Sponge Detachment Risk

    Covidien is recalling certain Cytosponge Cell Collection Devices and Kits because the sponge may detach from the string during removal, potentially causing device fragments, obstruction, and aspiration in patients.

    Product
    Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2266-2023·2023-08-09

    Endobronchial Cytology Needles Recalled for Electromagnetic Sensor Malfunction

    Olympus is recalling endobronchial navigation needles because an electromagnetic sensor malfunction can disable navigation guidance during medical procedures, potentially causing procedural delays.

    Product
    Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2295-2023·2023-08-09

    Medline Procedural Kits Recalled: Ultrasound Gel Sterility Concerns

    Medline recalls sterile and non-sterile procedural kits containing ultrasound gel that may not meet sterility specifications. 29,126 units distributed in US and internationally.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAM TRAY, Model Number: DYNJ33638J; b. BLOCK TRAY, Model Number: DYNJRA1543; c. BMT- NERVE PERIPH PK, Model Number: DYNJRA1247; d. CVOR ANGIOGRA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1066-2023·2023-08-09

    FDA Recalls PHENYLephrine Syringes Due to Sterility Validation Failure

    FDA is recalling 81,073 PHENYLephrine syringes manufactured by Central Admixture Pharmacy Services. The manufacturer lacks validation data for its sterilization processes, so the syringes may not be sterile.

    Product
    PHENYLephrine in 0.9% sodium chloride, 1000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0987-2023·2023-08-09

    NORepinephrine IV Bags Recalled for Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling NORepinephrine 4 mg/250 mL IV bags due to lack of sterility assurance caused by insufficient validation of decontamination cycles. The affected lots were distributed nationwide.

    Product
    NORepinephrine 4 mg/250 mL added to 0.9% sodium chloride 16 mcg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8097-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0997-2023·2023-08-09

    Neonatal TPN Starter Bags Recalled Due to Sterility Validation Failure

    Central Admixture Pharmacy Services is recalling 356 neonatal TPN starter bags due to lack of validation data for decontamination cycles. The sterility of the affected lots cannot be assured.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0404-1
    Category
    Drug
    Distribution
    Distributed nationwide