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.

10926–10950 of 53043

  • HighFDA (Devices)·Z-0360-2024·2023-11-29

    Avanos BALLARD Closed Suction System mislabeled for DEHP content

    Certain lots of AVANOS BALLARD Closed Suction System for Adults were labeled as DEHP-free but contain DEHP in tubing components. These units are used for mechanical ventilation and distributed in the US and South Africa.

    Product
    AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0373-2024·2023-11-29

    Biomet Compress Device Segmental Anchor Plugs Recalled for Metal Burrs

    Biomet has recalled certain Compress Device Segmental Anchor Plugs (16 MM) due to metal burrs in the transverse holes. These burrs may prevent the drill or pins from passing through, potentially extending surgical time.

    Product
    Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178406
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0393-2024·2023-11-29

    Philips MRI systems recalled for potential gradient coil fire hazard

    Philips is recalling 102 Intera 1.5T MRI systems worldwide due to a potential gradient coil failure that could produce smoke and fire. The affected devices are identified by product numbers 781195 and 781295.

    Product
    Intera 1.5T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0358-2024·2023-11-29

    Blood Gas Analyzer Cartridges Recalled for Potential Oxygen Measurement Errors

    The FDA is recalling GEM Premier 3000 PAK cartridges manufactured by Instrumentation Laboratory because they may incorrectly report high oxygen levels in patients with low blood oxygen, potentially delaying critical treatment.

    Product
    GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0361-2024·2023-11-29

    Ventlab AirFlow Manual Resuscitators Recalled for CO2 Rebreathing Risk

    SunMed Holdings is recalling Ventlab AirFlow manual resuscitators nationwide due to a backwards leak in the integrated manometer that allows CO2 rebreathing. Users should immediately discontinue use and contact the manufacturer.

    Product
    Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult Resuscitator REF #s: AF1140MB-M5, AF1140MB-D5, AF5142OB, AF5142MB, AF5142MB-D235, AF1142MBP, AF5142MBP, AF5140MB, AF5140MB-2…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0390-2024·2023-11-29

    Philips Achieva 1.5T MRI Device Recalled for Gradient Coil Fire Risk

    Philips is recalling 68 Achieva 1.5T MRI machines due to potential gradient coil component failure that could produce smoke and fire. No injuries have been reported.

    Product
    Achieva 1.5T Conversion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0349-2024·2023-11-29

    BD Alaris Pump Infusion Sets Contain Undisclosed DEHP

    BD Alaris Pump infusion sets labeled as DEHP-free actually contain di(2-ethylhexyl) phthalate. The worldwide recall affects multiple catalog numbers distributed throughout the US and internationally.

    Product
    BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore Tubing, Catalog # 10010483; BD AlarisTM Pump Infusion Set 1.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog # 10010453; BD…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0464-2024·2023-11-29

    Asenzya Hot & Spicy Cajun Style Seasoning recalled for undeclared sesame

    Asenzya Hot & Spicy Cajun Style Seasoning may contain undeclared sesame allergen. The recall affects 6,930 pounds distributed in Wisconsin.

    Product
    Asenzya Hot & Spicy Cajun Style Seasoning, Item 121331. Net Wt 15 lbs. Distributed by: Asenzya 7616 South Sixth Street, Oak Creek, WI 53154.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0330-2024·2023-11-29

    Choleodochoscope Models Recalled Due to Unvalidated Air Drying Process

    Aizu Olympus choleodochoscopes with unvalidated air drying processes may retain water in the channel after repair, risking microbial contamination and patient infection. Affected models: CHF-BP30, CHF-CB30L, CHF-P60.

    Product
    Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0111-2024·2023-11-29

    Hand Sanitizer Recalled for Excess Acetal and Acetaldehyde Contamination

    Integrity Biochem hand sanitizer recalled due to contamination with acetal and acetaldehyde at levels above FDA standards. The product was distributed to one Oklahoma distributor.

    Product
    Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)- drum. Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-052-03
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0365-2024·2023-11-29

    SafeSpot Manual Resuscitators Recalled for CO2 Rebreathing Risk

    SunMed Holdings is recalling SafeSpot manual resuscitators with integrated manometers due to a backwards leak that allows CO2 rebreathing. The defect affects multiple accessory configurations distributed nationwide.

    Product
    Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. SafeSpot Infant Resuscitator REF #s: SS3200OBPC-T, SS3204MB-D12, SS3200MB-2, SS3200MB-D1, SS3200OBP, SS3200MB-MMC, SS3200MBP-M00, SS3200MB-PW, SS3200MBP-2I…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0332-2024·2023-11-29

    Rhinolaryngoscope Models Recalled for Unvalidated Air Drying Process

    Aizu Olympus rhinolaryngoscopes (models ENF-T3, ENF-VT2, ENF-VT3) are recalled. The air-drying process for the instrument channel was not validated, and water remaining in some devices after repair poses contamination and infection risk.

    Product
    Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). Model Numbers: ENF-T3, ENF-VT2, ENF-VT3.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0397-2024·2023-11-29

    EXALT Model D Single-Use Duodenoscope Recalled for Lens Fluid Ingress

    Boston Scientific is recalling EXALT Model D Single-Use Duodenoscopes due to fluid ingress in the lens, which causes poor image quality during procedures.

    Product
    EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0372-2024·2023-11-29

    Surgical Anchor Plug Devices Recalled for Potential Metal Burrs

    Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent surgical drill passage and extend surgery time.

    Product
    Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178404
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0328-2024·2023-11-29

    Ultrasonic Bronchoscopes Recalled Due to Inadequate Drying Validation

    Aizu Olympus is recalling 823 ultrasonic bronchoscopes (models BF-UC180F, BF-UC190F) because the channel air drying process was not validated, and some repaired units retained water that could cause contamination and infection.

    Product
    Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the airways, trancheobronchial tree, esophagus and surrounding organs Model Numbers: BF-UC180F, BF-UC190F.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0350-2024·2023-11-29

    BD Gravity Infusion Sets Labeled DEHP-Free But Contain DEHP

    BD gravity blood infusion sets labeled as free of DEHP (di(2-ethylhexyl) phthalate) actually contain the substance. The recall affects products distributed worldwide through July 31, 2026.

    Product
    BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER SmartSiteTM VALVE NONVENTED, Catalog # 42081E.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0368-2024·2023-11-29

    Curaplex Manual Resuscitators Recalled for Potential CO2 Rebreathing Risk

    SunMed Holdings is recalling Curaplex manual resuscitators with integrated manometers due to a backwards leak in the patient valve that allows carbon dioxide rebreathing. All units manufactured from September 2018 to present and distributed nationwide are affected.

    Product
    Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF # 2442-BVMPAD; 2. Curaplex Child Premium BVM with Bag Reservoir, Manometer…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0391-2024·2023-11-29

    Philips Achieva 1.5T MRI Systems Recalled for Gradient Coil Fire Risk

    Philips is recalling Achieva 1.5T MRI systems because the gradient coil component could fail and produce smoke or fire. The recall affects 2 units distributed worldwide.

    Product
    Achieva 1.5T Initial System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0322-2024·2023-11-29

    Medtronic Mo.Ma Ultra Cerebral Protection Device manifold stickers mislabeled

    Medtronic has recalled the Mo.Ma Ultra Proximal Cerebral Protection Device due to mislabeled manifold stickers. Both sides of affected units were labeled identically, potentially causing confusion about which ports control the proximal versus distal balloons.

    Product
    Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0326-2024·2023-11-29

    Alinity c Iron Reagent Recalled for Falsely Elevated Test Results

    The FDA is recalling Alinity c Iron Reagent lots due to inaccurate results. The reagent produces falsely elevated patient iron values and may prevent proper quality control verification.

    Product
    Alinity c Iron Reagent, Reference Number 08P3920
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0338-2024·2023-11-29

    Tracheal Fiberscope Airway Management Devices Recalled for Inadequate Channel Drying

    Aizu Olympus is recalling 65 tracheal fiberscope units worldwide due to an unvalidated air drying process. Moisture remaining in device channels after repair could allow contamination and pose an infection risk.

    Product
    Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: LF-DP, LF-GP, LF-TP.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0352-2024·2023-11-29

    Roche Tina-quant D-Dimer Test System Recalled for Inaccurate Results

    Roche is recalling Tina-quant D-Dimer Test System kits because they produce elevated results when used with lithium-heparin plasma samples, potentially affecting diagnostic accuracy.

    Product
    Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0344-2024·2023-11-29

    Transnasal Esophagovideoscope Recalled Due to Unvalidated Drying Process

    Aizu Olympus is recalling the Transnasal Esophagovideoscope (Model PEF-V) because the channel air drying process was not validated, resulting in some units with wet channels that could cause infection.

    Product
    Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-V.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0386-2024·2023-11-29

    Surgical implant anchor plugs may contain metal burrs affecting insertion

    Biomet's Compress Device Short Anchor Plugs may contain metal burrs in the transverse holes, which can prevent proper insertion of surgical tools and extend surgery time. The affected devices are distributed nationwide and internationally.

    Product
    Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178566
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0110-2024·2023-11-29

    Hand Sanitizer Recalled for Chemical Contamination Above Specifications

    Integrity Biochem 70% alcohol hand sanitizer recalled due to acetal and acetaldehyde contamination above USP limits. The 55-gallon drums distributed in Oklahoma may not meet safety standards.

    Product
    Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-047-03
    Category
    Drug
    Distribution
    1 state