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.

43301–43325 of 50511

  • HighFDA (Drugs)·D-671-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Test Cyp 25 mg-e(2) Blend

    Clinical Specialties Compounding Pharmacy is recalling Test Cyp 25 mg-e(2) blend 12 mg/ml due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Test Cyp 25 mg-e(2) blend 12 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-1622-2013·2013-07-10

    Maquet YUNO Mobile Operating Table Recall for Extension Device Handle Issue

    Maquet is recalling YUNO mobile operating tables and extension devices because the handle design may allow operator skin to enter a gap.

    Product
    MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The YUNO OTN is used to support and position patients for surgical procedures immediately before, during and after the surgical phase. The table top is radio translucent and enables intraoperative use of…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-1591-2013·2013-07-10

    Food Concepts Recalls Big Country Breakfast Due to Salmonella Risk

    Food Concepts is recalling Big Country Breakfast because it contains texturized soy protein recalled by CHS, Inc. for possible salmonella contamination.

    Product
    BIG COUNTRY BREAKFAST, CASE WEIGHT 26 LBS., MANUFACTURED BY: FOOD CONCEPTS, LEBANON, TN 37087
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1666-2013·2013-07-10

    SpineFrontier Recalls InSpan Inserter Assemblies Due to Set Screw Deformation

    SpineFrontier, Inc. is recalling InSpan Inserter assemblies because a set screw may become deformed. The recall covers 61 units distributed worldwide.

    Product
    InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V303000·2013-07-10

    Ford Recalls 2013 C-Max Hybrids for Head Injury Safety Standard Failure

    Ford is recalling 2013 C-Max hybrid vehicles without panoramic roofs because they failed to meet federal head injury safety standards. Dealers will install energy absorbers to reduce injury risk in crashes.

    Product
    FORD — FORD redundant C-MAX HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1654-2013·2013-07-10

    HealthLink Biopsy Punches Recalled for Lack of Sterilization

    Clorox Healthcare Holdings is recalling HealthLink Biopsy Punches because they were not sterilized. The recall affects 1,044,600 units distributed in the US, Canada, Mexico, and New Zealand.

    Product
    HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1618-2013·2013-07-10

    Bard StatLock CV Plus Stabilization Devices Recalled for Assembly Error

    Bard Access Systems is recalling StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly that may cause skin irritation or catheter mis-orientation.

    Product
    StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock¿ device provides stabilization for compatible medical tubes and catheters.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1652-2013·2013-07-10

    Braemar Recalls Lithium Thionyl Battery Packs for ER920 Wireless Event Recorders

    Braemar, Inc. is recalling 3,286 non-rechargeable lithium thionyl battery packs used with ER920 Wireless Series Arrhythmia Event Recorders due to a battery-related incident.

    Product
    Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-624-2013·2013-07-10

    Baxter Recalls Sodium Chloride Injection Due to Sterility Concerns

    Baxter Healthcare is recalling specific lots of 0.9% Sodium Chloride Injection due to a manufacturing defect that may compromise sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1640-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls Reprocessed Medical Devices

    Surgical Instrument Service And Savings, Inc. is recalling 34 reprocessed medical devices because the sterile barrier seal became compromised, allowing product to fall out of the pouch.

    Product
    - ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 - Carpal Tunnel Release Blade Assembly, (White) Ref. 81010 Lot 123263, 122406, 122482, 123043, 122518, 122511 - ENDO-SCRUB 2, (1) Sheath, 0 Degree, For K. Storz, Medtronic Sharpsite AC…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1630-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls 73 Medical Devices with Compromised Sterile Seals

    Surgical Instrument Service And Savings, Inc. is recalling 73 surgical instruments and accessories because their sterile seals may be compromised, allowing product to fall out of the pouch.

    Product
    - Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 122447 - Cannulated Drill Bit, Quick Coupling, For 3.5 & 4mm Cannulated Screws, 1.35mm Cannulation 2.7mm x 160mm Ref. 310.67 Lot 122289 - Hall MicroChoice, Oscillating Blade, Fine, Flat, Stainless…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1593-2013·2013-07-10

    Food Concepts Recalls Ragin' Cajun Due to Salmonella Risk

    Food Concepts is recalling 76 cases of Ragin' Cajun because it contains texturized soy protein recalled for possible salmonella contamination.

    Product
    RAGIN' CAJUN, WEIGHT 32 LBS, MANUFACTURED BY: FOOD CONCEPTS, LEBANON, TN 37087
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1577-2013·2013-07-10

    Cheryls Peanut Butter Cookies Recalled for Undeclared Allergen

    Cheryls is recalling Fudge Buttercream Frosted Peanut Butter cookies because some were packaged in Cinnamon Pumpkin wrappers, creating an undeclared peanut allergen risk.

    Product
    Fudge Buttercream Frosted Peanut Butter cookies, some of which were mislabeled by being wrapped in Buttercream Frosted Cinnamon Pumpkin cookie wrappers, 1.6oz (45g) in size, 1 cookie per package, 100 cookies per case.
    Category
    Food
    Distribution
    47 states
  • HighFDA (Devices)·Z-1617-2013·2013-07-10

    Biosense Webster Recalls 20-Pole LASSO Nav Catheter Eco Due to Calibration Error

    Biosense Webster is recalling 10 units of the 20-Pole LASSO Nav Catheter Eco because incorrect calibration causes the CARTO 3 System to display them as 10-Pole devices.

    Product
    20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.
    Category
    Medical Device
    Distribution
    3 states
  • HighNHTSA·13E037000·2013-07-08

    Kuryakyn Recalls Handlebar Risers for Honda Goldwing Motorcycles

    Kuryakyn is recalling handlebar risers for Honda Goldwing GL1800s because mounting screws may break, potentially causing the handlebars to separate and increasing crash risk.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13E036000·2013-07-05

    Thermo King Recalls Precedent S-600 Refrigeration Units Due to Bracket Defect

    Thermo King is recalling Precedent S-600 transportation refrigeration units manufactured in April and May 2013 because the lifting bracket may break, posing a risk of injury if the unit falls.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V296000·2013-07-05

    Ameritrans M2 Series Bus Recalled for Wheelchair Lift Fire Risk

    Ameritrans is recalling one 2013 M2 Series bus because a wheelchair lift cable may not clear the lift, potentially causing a short circuit and fire.

    Product
    AMERITRANS — AMERITRANS M2 SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1597-2013·2013-07-03

    RF Technologies Recalls Code Alert Advanced 4-Way Care Solution Due to Firmware Error

    RF Technologies is recalling 167 Code Alert Advanced 4-Way Care Solution units because a firmware error may delay alarm transmission to the server.

    Product
    Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1566-2013·2013-07-03

    Sara Lee Bakery Buns Recalled for Possible Metal Fragments

    BIMBO Bakeries USA is recalling Sara Lee Hearty & Delicious White Bakery Buns due to possible metal fragments from a faulty manufacturing part.

    Product
    8 Bakery Buns Sara Lee Hearty & Delicious White Sara Lee, Downers Grove, IL 60515
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1557-2013·2013-07-03

    BIMBO Bakeries Recalls Sara Lee Sesame Seed Buns Due to Metal Fragments

    BIMBO Bakeries USA is recalling Sara Lee Colonial Party Pack Sesame Seed Enriched Buns due to possible metal fragments from a faulty manufacturing part.

    Product
    Colonial Party Pack Sesame Seed Enriched Buns - 12 count Sara Lee, Downers Grove, IL 60515
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1556-2013·2013-07-03

    BIMBO Bakeries Recalls Colonial Party Pack Enriched Buns for Metal Fragments

    BIMBO Bakeries USA is recalling 1,689 units of Colonial Party Pack Enriched Buns due to possible metal fragments from a faulty manufacturing part.

    Product
    Colonial Party Pack Enriched Buns - 12 count Sara Lee, Downers Grove, IL 60515
    Category
    Food
    Distribution
    4 states