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.

12151–12175 of 53080

  • HighFDA (Devices)·Z-2286-2023·2023-08-09

    Scican STATCLAVE G4 Chamber Autoclave Recall for Sterilization Risk

    Scican has recalled 3 STATCLAVE G4 tabletop autoclaves due to risk of incomplete sterilization if used with incompatible loads. Healthcare facilities should verify only compatible materials are sterilized.

    Product
    STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 622303
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0992-2023·2023-08-09

    Neonatal TPN Starter Bag Recall Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling Neonatal TPN Starter Bags because sterility cannot be assured and decontamination cycle validation data is lacking. The affected lot (36-254911) was distributed nationwide.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0401-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2273-2023·2023-08-09

    ACROBAT V Cardiac Stabilization System may fail to secure during surgery

    A latch defect in the ACROBAT V Vacuum Off-Pump System may prevent proper heart stabilization during cardiac surgery. Maquet Cardiovascular recalled 594 units distributed worldwide.

    Product
    ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2338-2023·2023-08-09

    Medline procedural kits recalled for ultrasound gel sterility concerns

    Medline is recalling 15,323 custom sterile and non-sterile procedural kits worldwide due to potential non-sterility of the Turkuaz ultrasound gel component. Kits were distributed between April 2020 and April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAPHY PACK, Model Number: DYNJ65963A; b. ARTHOGRAM TRAY, Model Number: PAIN1524B; c. ARTHROGRAM TRAY, Model Number: PAIN1524A; d. CARPAL TUNNEL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1313-2023·2023-08-09

    Pecan Products Recalled for Undeclared Allergens

    Houston Pecan Company is recalling certain 5-pound bags of pecan products that may contain undeclared tree nuts, peanuts, and wheat due to cross-contamination. Consumers with allergies to these ingredients should not consume these products.

    Product
    Medium Pecan Pieces 5 pound bag; Mammoth Pecan Halves 5 pound bag; Jr. Mammoth Pecan Halves 5 pound bag
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1333-2023·2023-08-09

    Raisins Recalled for Undeclared Tree Nuts, Peanuts, and Wheat

    Houston Pecan Company is recalling Dark and Gold Raisins in 5 pound bags due to potential undeclared tree nuts, peanuts, and wheat allergens from cross contamination. Products distributed in Texas and online are affected.

    Product
    Dark Raisins packaged in 5 pound bags; Gold Raisins packaged in 5 pound bags
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1349-2023·2023-08-09

    Gina Brand Sheeted Pizza Dough recalled for undeclared soy flour allergen

    Cassanos Inc is recalling Gina Brand Sheeted Pizza Dough in multiple sizes due to undeclared soy flour. Consumers with soy allergies are at risk of allergic reaction.

    Product
    Gina Brand Sheeted Pizza Dough: packaged as 8in, 10in, 12in (thin), 12in (regular), 14in, 16in (thin) and 16in (regular)
    Category
    Food
    Distribution
    9 states
  • HighFDA (Drugs)·D-1030-2023·2023-08-09

    Cardioplegia Solution 122 mEq K Recalled for Sterility Failure

    Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to lack of sterility assurance and missing validation data for decontamination. The product was distributed nationwide.

    Product
    CARDIOPLEGIA SOLUTION 122 mEq K, Modified St. Thomas Formula High Potassium, Total Volume = 1000 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0209-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1001-2023·2023-08-09

    FDA Recalls Neonatal TPN Starter Bag for Lacking Sterility Assurance

    Central Admixture Pharmacy Services recalls 68 neonatal TPN starter bags nationwide due to lack of validation data for decontamination cycles, posing a contamination risk.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0427-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2296-2023·2023-08-09

    Medline Procedural Kits Recalled for Potential Sterility Specification Failure

    Medline has recalled 63,823 custom procedural kits due to potential sterility specification failure of the ultrasound gel component. The affected kits were distributed worldwide from April 2020 through April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ902507B; b. ANGIO BASIN SET, Model Numbers: DYNJ46043D, DYNJ46043F; c. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609K…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0955-2023·2023-08-09

    Vancomycin IV Bags Recalled Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling 15,304 bags of vancomycin IV solution due to lack of validation data confirming proper sterilization of the product.

    Product
    vancomycin 1.25 g/250 mL added to 0.9% Sodium Chloride, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6074-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0947-2023·2023-08-09

    Rocuronium Injection Syringes Recalled for Sterility Assurance Deficiency

    FDA recalls 77,554 rocuronium syringes nationwide due to lack of sterility assurance and inadequate validation data for sterilization processes. The drug was repackaged by Central Admixture Pharmacy Services, Inc.

    Product
    rocuronium50 mg/5 mL (10 mg/mL), Syringes Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1310-2023·2023-08-09

    Greek Orzo Pasta Salad Recall Due to Undeclared Milk and Wheat

    Eat Good LLC is recalling Greek Orzo Pasta Salad because the label fails to declare milk and wheat allergens present in the product, posing a risk to consumers with allergies.

    Product
    Greek Orzo Pasta Salad is a food service refrigerated product, packaged in 5lb flexible plastic packages, 2/5lb. packages are packed in cardboard cases. The salads are removed from the package and sold by the pound from deli display cases at the grocery stores. Greek Orzo…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0979-2023·2023-08-09

    Heparin IV Bags Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 5,834 bags of heparin 5000 units/500mL IV bags nationwide due to insufficient validation of sterilization processes, creating potential contamination risk.

    Product
    heparin 5000 units/500mL added to 0.9% sodium chloride, 10 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7023-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2271-2023·2023-08-09

    Chest Stabilization Device Latch May Fail During Cardiac Surgery

    The ACCESSRAIL Platform Standard Blade may fail to latch securely, potentially causing loss of heart stabilization or device component release into patients during cardiac surgery.

    Product
    ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1328-2023·2023-08-09

    Banana Chips Recalled for Undeclared Tree Nuts, Peanuts, and Wheat

    Houston Pecan Company is recalling all 5-pound bags of banana chips purchased before May 25, 2023, due to potential undeclared tree nuts, peanuts, and wheat from cross-contamination.

    Product
    Banana Chips, Bananas, Coconut Oil, Refined Cane Sugar, Banana Flavor packaged in 5 pound bags
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1365-2023·2023-08-09

    Outshine Strawberry Fruit Bars Recalled for Undeclared Milk Allergen

    Dreyer's Grand Ice Cream is recalling Outshine No Sugar Added Strawberry Fruit Bars due to undeclared milk allergen. Consumers with milk allergies in affected states should not consume this product.

    Product
    Outshine No Sugar Added Strawberry Fruit Bars Brand name: Outshine; Unit size:14.7 fl oz carton with 6 bars; Container description: paper cartons; Total package size: 6 bars per case; Storage instructions: frozen
    Category
    Food
    Distribution
    17 states
  • HighFDA (Drugs)·D-1016-2023·2023-08-09

    FDA Recalls Cardioplegia Solution for Lack of Sterility Assurance

    The FDA has recalled Central Admixture Pharmacy Services' Cardioplegia Solution 40 mEq K due to insufficient validation data for sterilization processes. The 80-bag lot may not meet sterility standards required for cardiac use.

    Product
    CARDIOPLEGIA SOLUTION 40 mEq K, Warm Induction 4:1 High Potassium, IV Bag, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0002-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1330-2023·2023-08-09

    Red Tart Cherries Sweetened Recalled for Undeclared Allergens

    Houston Pecan Company is recalling Red Tart Cherries Sweetened in 5-pound bags due to potential cross-contamination with undeclared tree nuts, peanuts, and wheat allergens.

    Product
    Red Tart Cherries Sweetened packaged in 5 pound bags
    Category
    Food
    Distribution
    1 state
  • 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 (Food)·F-1314-2023·2023-08-09

    Almond Products Recalled for Undeclared Tree Nut and Peanut Allergens

    Houston Pecan Company is recalling multiple almond products due to potential undeclared tree nuts, peanuts, and wheat from cross-contamination. Affected 5-pound bags were sold in Texas and online prior to May 25, 2023.

    Product
    Whole Natural Almonds packaged in 5 pound bag; Whole Blanched Almonds packaged in 5 pound bag; Sliced Blanched Almonds packaged in 5 pound bag; Sliced Natural Almonds packaged in 5 pound bag; Almond Flour packaged in 5 pound bag; Smoked Almonds packaged in 5 pound bag; Slivered…
    Category
    Food
    Distribution
    1 state
  • 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 (Food)·F-1331-2023·2023-08-09

    Apple Rings Recalled for Undeclared Tree Nuts, Peanuts, Wheat

    Houston Pecan Company recalls Apple Rings in 5-pound bags due to potential undeclared allergens from cross-contamination with tree nuts, peanuts, and wheat.

    Product
    Apple Rings Sulfur Dioxide Added packaged in 5 pound bags; Apple Rings, 1/2 pound bag
    Category
    Food
    Distribution
    1 state
  • 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