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.

39026–39050 of 50506

  • HighFDA (Devices)·Z-1477-2015·2015-04-29

    Churchill Medical Systems Recalls 4-inch Trifurcated Sets Due to Leaking Risk

    Churchill Medical Systems is recalling 2,650 units of 4-inch trifurcated sets with Bionectors and check valves due to a potential for leaking caused by insufficient bonding.

    Product
    4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-609-2015·2015-04-29

    Attix Pharmaceuticals Recalls Dacarbazine Due to Penicillin Cross Contamination Risk

    Attix Pharmaceuticals is recalling Dacarbazine active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Dacarbazine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-938-2015·2015-04-29

    Attix Pharmaceuticals Recalls Tranexamic Acid Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Tranexamic Acid active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Tranexamic Acid active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2028-2015·2015-04-29

    Dairy Farmers of America Recalls Borden Good 2 Gether Snack Trays

    Dairy Farmers of America is recalling Borden Good 2 Gether Mild Cheddar Cheese & Pretzels snack trays due to a potential hard plastic fragment hazard.

    Product
    Borden Good 2 Gether, Mild Cheddar Cheese & Pretzels, UPC: 5300001111, Net Wt 2 0z (57 g), Dist. By DFA Dairy Farmers of America, PO Box 909700, Kansas City, MO 64190.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1491-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Dimensional Defects

    Wright Medical Technology is recalling 301 units of the Crosscheck Plating System because dimensional specifications are out of range, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, MTP NX Plate, Right, Recon, REF CCP-MPN2R. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-914-2015·2015-04-29

    Attix Pharmaceuticals Recalls Tamsulosin Base Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Tamsulosin Base active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Tamsulosin Base active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-703-2015·2015-04-29

    Attix Pharmaceuticals Recalls Heparin Sodium Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Heparin Sodium active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Heparin Sodium active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1500-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Specification Defects

    Wright Medical Technology is recalling 92 units of the Crosscheck Plating system because dimensional specifications are out of range, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, Y-PLATE CX, REF CCP-YPX1. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2017-2015·2015-04-29

    Rising Moon Organics Garlic and Veggie Ravioli Recalled for Listeria

    Carmel Food Group is recalling Rising Moon Organics Garlic and Veggie Ravioli because the spinach used in manufacturing was found to contain Listeria monocytogenes.

    Product
    Rising Moon Organics Garlic and Veggie Ravioli; Net Wt 8 oz. (227g) UPC 7 85030 00011 3 Distributed by Rising Moon Organics 313 Iron Horse Way Providence, RI 02908
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-909-2015·2015-04-29

    Sumatriptan Succinate Recalled for Potential Penicillin Cross Contamination

    Attix Pharmaceuticals is recalling Sumatriptan Succinate active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Sumatriptan Succinate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1467-2015·2015-04-29

    Churchill Medical Systems Recalls 6-Inch Trifurcated Extension Sets for Leaking Risk

    Churchill Medical Systems is recalling 5,200 6-inch trifurcated extension sets due to a potential leak caused by insufficient bonding between the needleless device and female luer.

    Product
    6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1518-2015·2015-04-29

    Hospira LifeCare PCA Infusion System Recalled for Door Design Flaw

    Hospira is recalling 38,882 LifeCare PCA infusion systems because the clear plastic door design allows excessive flexing, permitting unauthorized access to medication vials.

    Product
    The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or patients, to (self) Administer analgesia within clinician programmed and/or hospital defined medication limits.
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1476-2015·2015-04-29

    Churchill Medical Systems Recalls Bifurcated Sets Due to Leaking Risk

    Churchill Medical Systems is recalling 1,050 bifurcated sets with check valves and Bionectors due to a potential for leaking caused by insufficient bonding.

    Product
    Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-608-2015·2015-04-29

    D-Cycloserine API Recalled for Potential Penicillin Cross-Contamination

    Attix Pharmaceuticals is recalling D-Cycloserine active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    D-Cycloserine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-866-2015·2015-04-29

    Attix Pharmaceuticals Recalls Procarbazine HCl Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Procarbazine HCl active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Procarbazine HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-550-2015·2015-04-29

    Attix Pharmaceuticals Recalls Budesonide API Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling budesonide active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Budesonide active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-519-2015·2015-04-29

    Attix Pharmaceuticals Recalls Ammonium Tetrathiomolybdate Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Ammonium Tetrathiomolybdate active pharmaceutical ingredient due to potential penicillin cross-contamination from repackaging in a shared facility.

    Product
    Ammonium Tetrathiomolybdate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-616-2015·2015-04-29

    Attix Pharmaceuticals Recalls Darunavir API Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling all lots of Darunavir active pharmaceutical ingredient distributed between January 2012 and February 2015 due to potential penicillin cross-contamination.

    Product
    Darunavir active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1482-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Spec Failures

    Wright Medical Technology is recalling 51 units of the Crosscheck Plating System because dimensional specifications are out of range, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Left, REF CCP-HSX1L. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-652-2015·2015-04-29

    Attix Pharmaceuticals Recalls Estradiol Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Estradiol active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Estradiol active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-695-2015·2015-04-29

    Attix Pharmaceuticals Recalls Furosemide Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling furosemide active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Furosemide active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1468-2015·2015-04-29

    Churchill Medical Systems Recalls Bifurcated Extension Sets Due to Leaking Risk

    Churchill Medical Systems is recalling 100 Bifurcated Extension Sets because a defect may cause leaking. The sets are used to administer medical fluids.

    Product
    Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1458-2015·2015-04-29

    Spacelabs Pediatric Flow Sensor Kit Recalled for Inaccurate Low Flow Readings

    Del Mar Reynolds Medical is recalling Spacelabs Pediatric Flow Sensor Kits because they report inspiratory and expiratory tidal volumes lower than the actual volumes delivered to patients.

    Product
    Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventilators. Designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1463-2015·2015-04-29

    Thermedx Fluid Management System P4000 Recalled for Software Bugs

    Thermedx LLC is recalling 127 Fluid Management System P4000 units due to software bugs that could affect the accuracy of fluid deficit measurements.

    Product
    Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic procedures.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Drugs)·D-492-2015·2015-04-29

    Attix Pharmaceuticals Recalls 4-Aminopyridine Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling 4-Aminopyridine active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    4-Aminopyridine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide