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.

39951–39975 of 50506

  • HighNHTSA·14V792000·2014-12-16

    Honda Recalls Acura RLX Vehicles for Headlight Film Defect

    Honda is recalling specific 2014-2015 Acura RLX and RLX Hybrid vehicles because headlight film may delaminate, reducing light output and increasing crash risk.

    Product
    ACURA — ACURA RLX, RLX HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15047·2014-12-16

    WindowTex Recalls Custom Roller Shades Due to Falling Hazard

    WindowTex is recalling about 6,800 custom roller shades because a steel pin can dislodge, causing the shade to fall and pose an injury risk.

    Product
    Roller Window Shades
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V788000·2014-12-15

    Honda Recalls 2015 Crosstour Vehicles for Side Air Bag Defect

    Honda is recalling 2015 Crosstour vehicles because the side curtain air bag inflator tube may be incorrectly manufactured, potentially affecting air bag performance in a crash.

    Product
    HONDA — HONDA CROSSTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V790000·2014-12-15

    Volkswagen Recalls 2015 Jetta Vehicles for Headlight Software Defect

    Volkswagen is recalling 2015 Jetta vehicles because a software error may cause low beam headlights to turn off when high beams are activated, reducing visibility.

    Product
    VOLKSWAGEN — VOLKSWAGEN JETTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V789000·2014-12-15

    MINI Cooper Recall for Transmission Software Rollaway Risk

    BMW is recalling 2014-2015 MINI Cooper vehicles because incorrect transmission software may allow the car to roll away if the driver exits without engaging Park.

    Product
    MINI — MINI COOPER S, COOPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15045·2014-12-12

    UVEX Recalls Bicycle Helmets Due to Chinstrap Anchor Failure Risk

    UVEX Sports is recalling 46,800 bicycle helmets because the chinstrap anchor can fail, causing the helmet to slide off and posing a head injury hazard.

    Product
    UVEX Bicycle Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0493-2015·2014-12-10

    Bard Access Systems Recalls Non-Sterile GuardIVa Antimicrobial Hemostatic IV Dressing

    Bard Access Systems is recalling non-sterile GuardIVa Antimicrobial Hemostatic IV Dressing units that could potentially be used clinically.

    Product
    GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0495-2015·2014-12-10

    Zimmer PSI Knee System Recalled for Potential Misalignment Design Flaw

    Zimmer CAS is recalling 15 PSI Knee System units due to a design flaw that could lead to misalignment during surgery.

    Product
    PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0494-2015·2014-12-10

    Aircraft Medical Recalls McGrath MAC2 Video Laryngoscope Blades

    Aircraft Medical Limited is recalling McGrath MAC2 Video Laryngoscope Blades because the retaining clip may be difficult to engage, increasing the risk of the blade disconnecting during intubation.

    Product
    McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items, each individually peel-pouched and EtO sterilized. Product Usage: Single Use, sterile video laryngoscope blade for use with McGRATH MAC Video Laryngoscopes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0591-2015·2014-12-10

    Premier Research Labs Recalls Quantum Gallbladder Support for Undeclared Wheat

    Premier Research Labs is recalling Quantum Gallbladder Support capsules because they contain undeclared wheat, a major food allergen.

    Product
    Quantum Gallbladder Support, 60 capsules in dark plastic container, each capsule is 460 mg or 427 mg each; Item Number 12411; UPC 0773512411
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0504-2015·2014-12-10

    Teleflex Medical Recalls Aquapak Nebulizer Adaptors Due to Sterility Concerns

    Teleflex Medical is recalling Aquapak Nebulizer Adaptors because packaging seals may be open or weak, potentially compromising the sterility of the devices.

    Product
    Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL, Product No. 403133; Aqaupak Nebulizer Adaptor 028, Sterile, Shelfpak, Product No. 031-28 & 031-28F, Aqaupak Nebulizer Adaptor 033, Sterile, Shelfpak, Product No. 031-33; Aqaupak Nebulizer…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0490-2015·2014-12-10

    Gambro Recalls Polyflux Dialyzers Due to Potential Packaging Tears

    Gambro Renal Products Inc is recalling Polyflux Revaclear and Max Dialyzers because potential tears in the packaging may compromise the sterile barrier.

    Product
    Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0505-2015·2014-12-10

    Teleflex Medical Recalls Aquapak Nebulizer Adaptors Due to Seal Integrity Concerns

    Teleflex Medical is recalling Aquapak nebulizer adaptors because packaging seals may be open or weak, potentially affecting the sterility of the device.

    Product
    Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product No. 404128; Aqauapak 428 SW, 440 ML W/028 Adaptor, Intl, Product No. 404428; Aquapak 728 SW, 760 ML W/028 Adaptor, Product No. 037-28; Aquapak SW/EAU Sterile…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0592-2015·2014-12-10

    Premier Research Labs Recalls BiliVen Supplements Due to Undeclared Wheat

    Premier Research Labs is recalling BiliVen capsules because they contain undeclared wheat, a major allergen.

    Product
    Premier Research Labs BiliVen, 60 capsules in dark plastic container, each capsule is 460 mg or 427 mg each);Item Number 2411
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0593-2015·2014-12-10

    Gourmet Warehouse Red Wine Marinade Recalled for Undeclared Allergens

    R and S Gourmet Warehouse is recalling Red Wine Marinade bottles because the product contains undeclared soy, wheat, and anchovies.

    Product
    Gourmet Warehouse, Red Wine Marinade, 16 fl.oz. (473 mL), Ingredient: Soy Sauce, Salt, Black Pepper, Cayenne Pepper, Garlic, Red Wine, Vinegar, Worcestershire Sauce, Onions and Spices, P.O. Box 22764, Hilton Head Island, SC 29925.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0594-2015·2014-12-10

    Gourmet Warehouse Island Jerk Marinade Recalled for Undeclared Allergens

    R and S Gourmet Warehouse is recalling Island Jerk Marinade because the product contains undeclared soy, wheat, and anchovies.

    Product
    Gourmet Warehouse, Island Jerk Marinade, 16 fl oz. (473 mL), Ingredient: Soy Sauce, Lemon Juice, Thyme, Allspice, Onion, Garlic, Cayenne Pepper, Salt, Savory Paprika, Spices, P.O. Box 22764, Hilton Head Island, SC 29925.
    Category
    Food
    Distribution
    6 states
  • HighCPSC·15046·2014-12-10

    GCI Outdoor Recalls Stadium Seats Due to Backrest Failure Risk

    GCI Outdoor is recalling about 6,000 BleacherBack stadium seats because the backrest can fail, posing a risk of injury. Consumers should stop using the seats and contact the company for a repair kit.

    Product
    Stadium seats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0489-2015·2014-12-10

    Gambro Recalls Polyflux Revaclear Dialyzers Due to Packaging Defects

    Gambro Renal Products Inc is recalling Polyflux Revaclear and Max Dialyzers because potential tears in the packaging may compromise the sterile barrier.

    Product
    Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0506-2015·2014-12-10

    Alcon Recalls INFINITI Vision System Ultrasound FMS Due to Tubing Debris

    Alcon is recalling INFINITI Vision System Ultrasound FMS units because pieces of tubing may be present in the aspiration line.

    Product
    INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE. Model Numbers: 8065741080, 8065741081, 8065741082, 8065741083, 8065741085, 8065741087, 8065741088, 8065741089, 8065741093, 8065741096, 8065741097, 8065741099, 8065750266, 8065750268…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0496-2015·2014-12-10

    Cure Medical Recalls Pediatric Urinary Catheters Due to Labeling Error

    Cure Medical is recalling pediatric urinary catheters because some boxes are mislabeled as size 8 but contain size 10 catheters, posing a risk of injury.

    Product
    Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate Box Label UPC (P10) *+M405P103F* Carton Label UPC (P10) *+M405P105H* The product is distributed individually or in intermediate boxes containing 30 individual…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·15712·2014-12-10

    Ethan Allen Recalls Harwood Floor Lamps Due to Electrical Shock Risk

    Ethan Allen is recalling Harwood floor lamps because a defect in the line cord insulation poses a risk of electrical shock. One incident of electrical shock has been reported.

    Product
    Harwood Floor Lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0492-2015·2014-12-10

    Ethicon Recalls PERMA-HAND Silk Suture Due to Sterility Assurance Concerns

    Ethicon is recalling PERMA-HAND silk sutures because the company cannot ensure the products meet the expected sterility assurance level.

    Product
    Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0491-2015·2014-12-10

    Integra Selector Kit Tubing Recalled for Potential Irrigation Fluid Leakage

    Integra LifeSciences is recalling 6,358 Selector Kit tubing units because they may leak irrigation fluid during use if not placed correctly on the handpiece.

    Product
    Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator system. One of the tubing lumen transmits irrigation fluid from the console to the handpiece of the system, and the other tubing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·084-2014·2014-12-10

    Real Foods LLC Recalls Chef Salads Due To Undeclared Anchovies

    Real Foods LLC is recalling Chef Salad with Ham and Turkey because the product contains anchovies, an undeclared allergen, and is mislabeled with the wrong dressing.

    Product
    Washington Firm Recalls Chef Salads with Ham and Turkey Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    2 states