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.

24651–24675 of 50442

  • HighFDA (Food)·F-0052-2020·2019-10-23

    Jansal Valley Snack Mix Recalled for Incorrect Allergen Labeling

    Friendly Fruit Market is recalling Jansal Valley Energize Snack Mix because the label lists allergens that are not actually in the product.

    Product
    Jansal Valley brand Energize Snack Mix NET WT 5 OZ (142 G) in plastic clamshells, Ingredients: apricots, almonds, banana chips, coconut, cashews, dates, raisins, hazelnuts, pecans, pepitas, walnuts, papaya, pineapple. Contains: almonds, cashews, coconut, hazelnuts, pecans…
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-0138-2020·2019-10-23

    ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk

    ICU Medical is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filter air vents. The recall covers 6,400 units distributed in the U.S. and internationally.

    Product
    Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0139-2020·2019-10-23

    ICU Medical Recalls Plum Microbore Infusion Sets Due to Fluid Leakage Risk

    ICU Medical Inc is recalling 521 units of Plum Microbore Infusion Sets because air vents on inline filters may leak fluid. The recall covers nationwide and international distribution.

    Product
    Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set, 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0127-2020·2019-10-23

    ICU Medical Recalls Plum Microbore Infusion Sets Due to Fluid Leakage

    ICU Medical Inc is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filter air vents.

    Product
    Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock, 104 Inch. 1 unit per pouch; 50…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0146-2020·2019-10-23

    ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk

    ICU Medical Inc is recalling Sapphire Microbore Infusion Sets with Inline Filters due to a potential for fluid leakage out of air vents.

    Product
    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case. Not distributed in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0141-2020·2019-10-23

    Spectrum Chemical Recalls Fentanyl Citrate Due to Glass Contamination

    Spectrum Laboratory Products is recalling Fentanyl Citrate USP active pharmaceutical ingredient due to potential glass contamination. The product was distributed to compounding pharmacies and labs in four states.

    Product
    Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Food)·F-0036-2020·2019-10-23

    Gullah Gourmet Recalls Nana's Been a Nut Bread for Missing Walnut Labeling

    Gullah Gourmet, Inc. is recalling 673 bags of Nana's Been a Nut Bread because the ingredient statement does not list walnuts, posing a risk to consumers with walnut allergies.

    Product
    Nana's Been a Nut Bread NET WT. 11oz/311.74g cloth bag CONTAINS WHEAT AND SOY. MADE ON EQUIPMENT THAT MAKES PRODUCTS CONTAINING WHEAT, EGGS, MILK, SOY AND TREE NUTS. GULLAH BOURMET Inc. CHARLESTON, SC 29407 UPC 6 50305 01045 9
    Category
    Food
    Distribution
    16 states
  • HighFDA (Food)·F-0051-2020·2019-10-23

    Jansal Valley Snack Mix Recalled for Incorrect Allergen Labeling

    Friendly Fruit Market is recalling Jansal Valley Indulgent Snack Mix because the label lists allergens not actually in the product.

    Product
    Jansal Valley brand Indulgent Snack Mix NET WT 12 OZ (340 G) in plastic clamshells, Ingredients: apricots, almonds, banana chips, coconut, cashews, dates, raisins, hazelnuts, pecans, pepitas, walnuts, papaya, pineapple. Contains: almonds, cashews, soy. This product is packaged…
    Category
    Food
    Distribution
    9 states
  • HighNHTSA·19V755000·2019-10-23

    BMW Recalls 2020 330i and M340i for Trunk Release Cable Defect

    BMW is recalling 2020 330i and M340i vehicles because an improperly installed trunk release cable may prevent the trunk from opening from the inside.

    Product
    BMW — BMW 330I, M340I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0122-2020·2019-10-23

    Medtronic Euphoria Balloon Catheters Recalled for Stylette Removal Difficulties

    Medtronic is recalling Euphoria Rapid Exchange Balloon Dilatation Catheters because a slightly higher diameter stylette causes removal difficulties.

    Product
    Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0143-2020·2019-10-23

    ICU Medical Recalls Sapphire Microbore Infusion Sets Due to Leakage Risk

    ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filter air vents. The product was distributed in the U.S. and internationally.

    Product
    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case . Not distributed in the U.S.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0125-2020·2019-10-23

    OrthoPediatrics Recalls Adolescent Attachment Bolts Due to Interference Risk

    OrthoPediatrics Corp is recalling 211 units of Adolescent attachment bolts used with the Pediatric Nailing Platform. The recall is due to potential interference between the bolt and nail, which may delay surgical procedures.

    Product
    OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the intramedullary fixation rod) Part number: 01-1503-0032
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0147-2020·2019-10-23

    ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk

    ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filters. The recall covers units distributed nationwide and internationally.

    Product
    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0135-2020·2019-10-23

    ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk

    ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filters. The recall covers 4,600 units distributed nationwide and internationally.

    Product
    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0137-2020·2019-10-23

    ICU Medical Recalls Plum Microbore Infusion Sets Due to Fluid Leakage Risk

    ICU Medical Inc is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filters. The affected units were distributed nationwide and internationally.

    Product
    Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0145-2020·2019-10-23

    ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk

    ICU Medical Inc is recalling 7,920 units of Plum Microbore Infusion Sets because fluid may leak from the inline filters.

    Product
    Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, 107 Inch. 1 unit per pouch; 48 pouches per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0148-2020·2019-10-23

    Siemens Atellica CH 930 Analyzer Recalled for Erroneous Hemolysis and Lipemia Indices

    Siemens Healthcare Diagnostics is recalling 1,125 Atellica CH 930 Analyzers worldwide due to software errors that may produce incorrect hemolysis and lipemia indices.

    Product
    Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0151-2020·2019-10-23

    Xodus Medical Recalls Cautery Tip Cleaners Due to Sterile Barrier Concerns

    Xodus Medical Inc is recalling 255,000 Cautery Tip Cleaners because the sterile barrier of some devices may have been affected.

    Product
    Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0150-2020·2019-10-23

    Xodus Medical Recalls Electrosurgical Tip Cleaners Due to Sterile Barrier Concerns

    Xodus Medical Inc is recalling 460,000 Electrosurgical Tip Cleaners because the sterile barrier of some devices may have been affected.

    Product
    Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessory
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0159-2020·2019-10-23

    Olympus Berkeley Disposa-Filter Recall Due to Weld Defect

    Olympus is recalling Berkeley Disposa-Filters used with the VC-10 Vacuum Curettage System because an ultrasonic weld defect may cause the housing to separate.

    Product
    Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·20010·2019-10-22

    Blackhawk T-Series L2C Gun Holsters Recalled for Injury Hazard

    Federal Cartridge is recalling Blackhawk T-Series L2C gun holsters because the design can accidentally change a firearm's safety switch, posing an injury risk.

    Product
    Blackhawk T-Series L2C gun holsters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19E073000·2019-10-21

    H&H Sports Recalls VCAN V531 Motorcycle Helmets for Retention Failure

    H&H Sports Protection is recalling VCAN V531 motorcycle helmets sold on Amazon because the retention system may fail, allowing the helmet to separate from the head during a crash.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide