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.

38976–39000 of 50506

  • HighFDA (Drugs)·D-524-2015·2015-04-29

    Attix Pharmaceuticals Recalls Artemether Due to Penicillin Cross-Contamination Risk

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

    Product
    Artemether 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-1485-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Specification Defects

    Wright Medical Technology is recalling 102 units of the Crosscheck Plating System because specific dimensions are out of specification, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Right, REF CCP-LPX0R. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-751-2015·2015-04-29

    Attix Pharmaceuticals Recalls Letrazole Due to Penicillin Cross-Contamination Risk

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

    Product
    Letrazole 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-1490-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Specification Defects

    Wright Medical Technology is recalling 167 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-863-2015·2015-04-29

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

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

    Product
    Procainamide 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-503-2015·2015-04-29

    Adenosine API Recalled for Potential Penicillin Cross Contamination

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

    Product
    Adenosine 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-1517-2015·2015-04-29

    Hospira PCA 3 Infusion Pump Recalled for Door Design Flaw

    Hospira is recalling 8,214 PCA 3 infusion pumps because the clear plastic door design allows excessive flexing, permitting unauthorized access to medication vials.

    Product
    The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits.
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Drugs)·D-732-2015·2015-04-29

    Attix Pharmaceuticals Recalls Indocyanine Green Due to Penicillin Cross-Contamination Risk

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

    Product
    Indocyanine Green 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-1497-2015·2015-04-29

    Wright Medical Crosscheck Plating System Recalled for Dimensional Defects

    Wright Medical Technology is recalling 138 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-935-2015·2015-04-29

    Tolvaptan API Recalled for Potential Penicillin Cross Contamination

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

    Product
    Tolvaptan 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-1464-2015·2015-04-29

    DiaSorin Recalls PRO-Trac II Tacrolimus ELISA Kits Due to Instability

    DiaSorin is recalling 451 PRO-Trac II Tacrolimus ELISA kits because instability may cause falsely elevated patient results.

    Product
    DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-839-2015·2015-04-29

    Attix Pharmaceuticals Recalls Phenolphthalein Due to Penicillin Cross-Contamination Risk

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

    Product
    Phenolphthalein 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-2015-2015·2015-04-29

    Ricos Tostaditos Vegetal Skins Recalled for Undeclared Wheat and Soy Oil

    Ricos Tostaditos, Inc. is recalling 300 bags of Ricos Tostaditos Vegetal Skins due to undeclared wheat and soy oil allergens.

    Product
    RICOS Tostaditos Vegetal Skins Imitation Rinds Chicharron Vegetal Crispy and Delicious Net Wt. 3/4 oz. (21g)
    Category
    Food
    Distribution
    4 states
  • HighFDA (Drugs)·D-786-2015·2015-04-29

    Attix Pharmaceuticals Recalls Methotrexate Due to Penicillin Cross-Contamination Risk

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

    Product
    Methotrexate USP 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-860-2015·2015-04-29

    Attix Pharmaceuticals Recalls Pregelatinized Starch Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Pregelatinized Starch pharmaceutical ingredients due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Pregelatinized Starch 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-650-2015·2015-04-29

    Attix Pharmaceuticals Recalls Epinephrine Ingredient Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling epinephrine active pharmaceutical ingredient distributed to compounding pharmacies and research organizations due to potential penicillin cross-contamination.

    Product
    Epinephrine 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-1488-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Dimensional Defects

    Wright Medical Technology is recalling 148 units of the Crosscheck Plating system because specific dimensions are out of specification, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 2mm Step, Left, REF CCP-LPX2L. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-570-2015·2015-04-29

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

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

    Product
    Celecoxib 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-660-2015·2015-04-29

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

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

    Product
    Ethambutol 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 (Devices)·Z-1515-2015·2015-04-29

    Abbott OptiMedica Catalys Precision Laser System Recalled for Corneal Scoring Risk

    Abbott Medical Optics is recalling 202 OptiMedica Catalys Precision Laser Systems because loss of suction during cataract surgery may cause corneal scoring.

    Product
    OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1470-2015·2015-04-29

    Churchill Medical Systems Recalls 4-inch Microbore Trifurcated Extension Sets

    Churchill Medical Systems is recalling 2,200 units of 4-inch Microbore Trifurcated Extension Sets due to a potential leak caused by insufficient bonding between the needleless device and female luer.

    Product
    4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2016-2015·2015-04-29

    Ricos Tostaditos Vegetal Skins Recalled for Undeclared Wheat and Soy Oil

    Ricos Tostaditos, Inc. is recalling 150 bags of Ricos Tostaditos Vegetal Skins because the product contains undeclared wheat and soy oil.

    Product
    RICOS Tostaditos Vegetal Skins Imitation Rinds Chicharron Vegetal Hot Crispy and Delicious Net Wt. 3/4 oz. (21g)
    Category
    Food
    Distribution
    4 states
  • HighFDA (Drugs)·D-648-2015·2015-04-29

    Attix Pharmaceuticals Recalls Enalapril Maleate Due to Penicillin Cross-Contamination Risk

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

    Product
    Enalapril Maleate 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-884-2015·2015-04-29

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

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

    Product
    Roflumilast 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