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.

39601–39625 of 50506

  • HighFDA (Devices)·Z-1042-2015·2015-02-11

    Zimmer Persona Tibial Inserter Recalled for Potential Tip Fracture

    Zimmer, Inc. is recalling 1,091 Persona Tibial Articular Surface Inserters due to a potential fracture of the instrument tip, which could cause tissue damage or require revision surgery.

    Product
    Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0977-2015·2015-02-11

    Riba Foods Recalls Salpica Ballpark Nachos Due to Undeclared Wheat

    Riba Foods Inc is recalling Salpica 8 oz. Ballpark Nachos because the product may contain undeclared wheat. The recall affects 6,564 units distributed across 23 states.

    Product
    Salpica 8 oz. Ballpark Nacho; 6 units per case
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·F-0976-2015·2015-02-11

    Riba Foods Recalls Salpica Salsa Con Queso for Undeclared Wheat

    Riba Foods Inc is recalling Salpica Salsa Con Queso because the product may contain undeclared wheat. This poses a risk to individuals with wheat allergies or celiac disease.

    Product
    Salpica 11.5 oz., 16 oz., Salsa Con Queso; 12 units per case
    Category
    Food
    Distribution
    23 states
  • HighCPSC·15077·2015-02-11

    System Sensor Recalls Combination Carbon Monoxide and Smoke Detectors

    System Sensor is recalling i4 Series combination CO/smoke detectors because they may fail to detect carbon monoxide, posing a poisoning risk.

    Product
    i4 Series System Sensor combination carbon monoxide (CO)/smoke detectors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1038-2015·2015-02-11

    SCC Soft Computer Recalls SoftLab Laboratory Information System Versions

    SCC Soft Computer is recalling SoftLab versions 4.0.7.0 and 4.0.7.1 because the software fails to send abnormal flags for Reference Lab test results.

    Product
    SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0972-2015·2015-02-11

    Zilks Foods Recalls Green Chili Hummus Due to Undeclared Peanuts

    Zilks Foods is recalling 3,176 cups of Green Chili Hummus because the cumin ingredient may contain undeclared peanuts.

    Product
    Hummus; All-natural ZILKS HATCH GREEN CHILI HUMMUS GLUTEN FREE & NON-GMO NET WT. 8 OZ
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0971-2015·2015-02-11

    Zilks Foods Recalls Balsamic and Garlic Hummus for Undeclared Peanuts

    Zilks Foods is recalling 2,424 cups of Balsamic and Garlic Hummus due to potential undeclared peanuts in the cumin ingredient.

    Product
    Hummus; All-natural ZILKS BALSAMIC & GARLIC HUMMUS GLUTEN FREE & NON-GMO NET WT. 8 OZ
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0973-2015·2015-02-11

    Zilks Spinach and Artichoke Hummus Recalled for Undeclared Peanuts

    Zilks Foods is recalling Spinach & Artichoke Hummus because the cumin ingredient may contain undeclared peanuts.

    Product
    Hummus; All-natural ZILKS SPINACH & ARTICHOKE HUMMUS GLUTEN FREE & NON-GMO NET WT. 8 OZ
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1049-2015·2015-02-11

    Carl Zeiss Meditec FORUM Archive and Viewer Software Recall

    Carl Zeiss Meditec is recalling FORUM Archive and Viewer software versions 3.1 and 3.2 due to a defect that may lead to misinterpretation of optical coherence tomography data.

    Product
    FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928 (USB drive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1060-2015·2015-02-11

    Shape Medical Systems Recalls Cardiopulmonary Testing System Patient Interfaces

    Shape Medical Systems is recalling 564 disposable patient interfaces for the Shape-HF Cardiopulmonary Testing System because they may produce erroneous results, potentially leading to incorrect diagnosis and treatment.

    Product
    Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1039-2015·2015-02-11

    Baxter Integrated APD Set Recalled for Leakage Complaints

    Baxter Healthcare is recalling 8,640 units of Integrated APD Sets with Cassette 3-Prong due to leakage complaints. The sterile fluid path is used for peritoneal dialysis.

    Product
    Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product Usage: The recall device is indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD Systems in clinical and home use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1040-2015·2015-02-11

    Sedecal MobileDiagnost wDR X-ray systems recalled for unexpected movement

    Sedecal S.A. is recalling 283 MobileDiagnost wDR motorized portable diagnostic X-ray systems due to reports of unexpected movement.

    Product
    MobileDiagnost wDR motorized portable diagnostic X-ray systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1046-2015·2015-02-11

    Radiometer ABL90 FLEX Analyzer Recall for Calibration Data Errors

    Radiometer America Inc. is recalling ABL90 FLEX analyzers because they may not use the most recent calibration data, potentially leading to biased patient results.

    Product
    ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Food)·F-0969-2015·2015-02-11

    Zilks Roasted Red Pepper Hummus Recalled for Undeclared Peanuts

    Zilks Foods is recalling 4,008 cups of Roasted Red Pepper Hummus due to potential undeclared peanuts in the cumin ingredient.

    Product
    Hummus; All-natural ZILKS ROASTED RED PEPPER HUMMUS GLUTEN FREE & NON-GMO NET WT. 8 OZ
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1055-2015·2015-02-11

    BD 10 mL Syringes Recalled Due to Improperly Seated Stopper

    Becton Dickinson is recalling 564,000 units of 10 mL syringes because the stopper is not properly seated in the syringe.

    Product
    BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40 mm), not for skin injection; Catalog #305064 BD 10 mL Syringe Luer-Lok Tip with BD…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0968-2015·2015-02-11

    Zilks Hummus Recalled for Potential Undeclared Peanuts

    Zilks Foods is recalling 4,768 cups of hummus nationwide due to potential undeclared peanuts in the cumin ingredient.

    Product
    Hummus; All-natural ZILKS FAMOUS ORIGINAL HUMMUS GLUTEN FREE & NON-GMO NET WT. 8 OZ
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1052-2015·2015-02-11

    Zimmer Recalls Persona Tibial Articular Surface Provisional Shims Due to Cleaning Defect

    Zimmer, Inc. is recalling Persona Tibial Articular Surface Provisional Shims because repeated sonic cleaning can break the ball bearing retention feature, potentially leaving parts in the surgical wound.

    Product
    Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04. Product Usage: The Persona TASPs are sterilizable instruments Intended for multiple uses. The TASP components are used to aid the surgeon in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1041-2015·2015-02-11

    Roche Cobas b 221 Blood Gas Analyzer Recalled for Measurement Bias

    Roche Diagnostics is recalling 103 Cobas b 221 analyzers because bacterial contamination causes inaccurate glucose and lactate readings.

    Product
    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0974-2015·2015-02-11

    Zilks Hummus with Real Bacon Recalled for Potential Undeclared Peanuts

    Zilks Foods is recalling 3,808 cups of hummus with real bacon due to potential undeclared peanuts in the cumin ingredient.

    Product
    Hummus; All-natural ZILKS HUMMUS with REAL BACON GLUTEN FREE & NON-GMO NET WT. 8 OZ
    Category
    Food
    Distribution
    Distributed nationwide