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.

35376–35400 of 50504

  • HighFDA (Devices)·Z-1979-2016·2016-06-22

    Navilyst Medical Recalls Xcela Hybrid PICC Catheters with Valve Technology

    Navilyst Medical is recalling 157 units of Xcela Hybrid PICC catheters because they lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling.

    Product
    Xcela Hybrid PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965952420 & UPN H965952460, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1974-2016·2016-06-22

    Navilyst Recalls Xcela PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 105 Xcela PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1477-2016·2016-06-22

    CSM Bakery Chocolate Chip Cookies Recalled for Undeclared Peanut Allergen

    CSM Bakery Products NA is recalling 21-pound cases of Chocolate Chip Cookies due to undeclared peanut protein. The product was distributed across 19 U.S. states and Colombia.

    Product
    Chocolate Chip Cookie, Net Weight: 21 lbs (9.53 kgs).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1464-2016·2016-06-22

    CSM Bakery Products Recalls Mini Sugar Cookie Dough for Undeclared Peanut

    CSM Bakery Products NA is recalling 0.5 oz. TranSmart Mini Sugar Cookie Dough because it contains undeclared peanut protein. The product was distributed in 20 US states and Colombia.

    Product
    0.5 oz. TranSmart, Mini Sugar Cookie Dough, Net Weight 22.5 lbs (10.20 kg).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1990-2016·2016-06-22

    Stryker PowerPRO Cots Recalled for Smoke and High-Speed Retract Reports

    Stryker is recalling 770 PowerPRO ambulance cots due to reports of smoke from the foot end and unexpected high-speed retraction.

    Product
    Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Power-PRO" are powered ambulance cots are designed to support and transport a maximum weight of 700 lb. (318 kg) in pre-hospital and hospital environments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1449-2016·2016-06-22

    Cinnabon Caramel Pecan Cookies Recalled for Undeclared Peanut Allergen

    CSM Bakery Products NA is recalling Cinnabon Caramel Pecan cookies because they contain undeclared peanut protein, posing a risk to individuals with peanut allergies.

    Product
    Cinnabon Caramel Pecan, 3 oz. Cookie, Net Weight 23.45 lbs. (10.63 kg).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1513-2016·2016-06-22

    Clight Drink Mix Recalled for Undeclared Soy Ingredient

    Mondelez Puerto Rico is recalling Clight drink mix products because they contain soy lecithin but do not declare soy on the label.

    Product
    Label reads in part as: "Clight***Lim¿n*** Lemon ***CALORIE FREE ARTIFICIALLY FLAVORED DRINK MIX***TWO PACKAGES IN ONE***MAKES 1 LITER***NET: 0.49 oz*** Distributed by: Mondelez Puerto Rico, LLC, Montehiedra Office Center Suite 801, 9615 Ave. Los Romeros, San Juan PR…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1975-2016·2016-06-22

    Navilyst Recalls Xcela PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 568 Xcela PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    Xcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965251290 & H965457420, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1954-2016·2016-06-22

    Zimmer Biomet Recalls Specific Lots of Trabecular Metal Implants

    Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to potential issues with the foil pouches used for sterile integrity.

    Product
    REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 REV. SHELL LINER 10D 28X52 00701005228 REV. SHELL LINER 10D 28X54 00701005428 REV. SHELL LINER 10D 28X56 00701005628 REV. SHELL LINER 10D 28X58 00701005828 REV. SHELL LINER 10D…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1500-2016·2016-06-22

    Oasis Trading Recalls Chef's Quality Creamy Liquid Fry Oil Due to Foreign Material

    Oasis Trading Co., Inc. is recalling 8,399 containers of Chef's Quality Creamy Liquid Fry Oil because the bottles were reported to contain high density polyethylene resin trim rings.

    Product
    Chef's Quality Creamy Liquid Fry Oil, Net Wt. 35 LBS (15.87 kg), Distributed by: R.D. Enterprises, Inc., College Point, NY 11356, UPC 7 60695 00482 9
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1446-2016·2016-06-22

    CSM Bakery Recalls Unbaked Chocolate Chip Cookies Due to Undeclared Peanut

    CSM Bakery Products NA is recalling 34,525 cases of Unbaked Chocolate Chip Cookies because they contain undeclared peanut protein.

    Product
    ¿ Sheet Unbaked Message Cookie, 20/20 oz. Unbaked Chocolate Chip Cookies, Net Weight 25 lbs/11.34 kg.
    Category
    Food
    Distribution
    19 states
  • HighCPSC·16754·2016-06-22

    Ecovent Recalls Room Sensors Due to Electrical Shock Hazard

    Ecovent is recalling about 600 room sensors because the cover can come off, exposing high-voltage components and posing an electrical shock hazard.

    Product
    Ecovent room sensors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1465-2016·2016-06-22

    CSM Bakery Products Recalls TranSmart Sugar Cookies Due to Undeclared Peanut

    CSM Bakery Products is recalling TranSmart Sugar Cookies because they contain undeclared peanut protein. The recall covers 34,525 cases distributed across 20 U.S. states and Colombia.

    Product
    TranSmart, Sugar Cookie, 240 1.5 oz. Cookies, Net Weight: 22.5 lbs/10.21 kg.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1470-2016·2016-06-22

    CSM Bakery Products Recalls TranSmart Chocolate Chip Cookies for Undeclared Peanut

    CSM Bakery Products NA is recalling TranSmart Chocolate Chip Cookies because they contain undeclared peanut protein. The recall covers 34,525 cases distributed across 20 US states and Colombia.

    Product
    TranSmart, Chocolate Chip Cookie, 240 1.5oz cookies, Net Weight 22.5 lbs/10.21 kg.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1511-2016·2016-06-22

    Clight Drink Mix Recalled for Undeclared Soy Ingredient

    Mondelez Puerto Rico is recalling Clight drink mix products in four flavors because they contain soy lecithin but do not declare soy on the label.

    Product
    Label reads in part as: "Clight***Mandarina*** Tangerine***CALORIE FREE ARTIFICIALLY FLAVORED DRINK MIX***TWO PACKAGES IN ONE***MAKES 1 LITER***NET: 0.49 oz*** Distributed by: Mondelez Puerto Rico, LLC, Montehiedra Office Center Suite 801, 9615 Ave. Los Romeros, San Juan PR…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1982-2016·2016-06-22

    Navilyst Medical Recalls BioFlo PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 438 BioFlo PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 & UPN H965458840, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1969-2016·2016-06-22

    Navilyst Recalls Vaxcel PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling Vaxcel PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces the incidence of hemolysis during blood sampling.

    Product
    Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M001454570, Rx ONLY, 2) 5F, UPN M001454620 & UPN M001454720, Rx ONLY & 3) 6F, UPN M001454770, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1971-2016·2016-06-22

    Navilyst Vaxcel PICC Catheters Recalled for Hemolysis Risk During Blood Sampling

    Navilyst Medical is recalling 210 Vaxcel PICC catheters manufactured before July 15, 2014, due to a lack of specification changes that reduce hemolysis during blood sampling.

    Product
    Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001455910, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1950-2016·2016-06-22

    Zimmer Biomet Recalls Specific Lots of Trabecular Metal Implants

    Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to a defect in the foil pouches used for sterile integrity.

    Product
    POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATELLA 38MM X 10MM - 00587806538 POROUS PATELLA 41MM X 10MM - 00587806541
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1483-2016·2016-06-22

    CSM Bakery Recalls Frozen Oatmeal Raisin Cookie Dough for Undeclared Peanut

    CSM Bakery Products NA is recalling frozen pre-cut oatmeal raisin cookie dough because it contains undeclared peanut protein.

    Product
    Oatmeal Raisin, Frozen Pre-cut Cookie Dough, Net Weight 23.44 lbs/10.63 kgs and 24.61 lbs (11.16 kgs)
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1968-2016·2016-06-22

    Navilyst Medical Recalls Vaxcel PICC Catheters with PASV Valve

    Navilyst Medical is recalling Vaxcel PICC catheters with PASV valves manufactured before July 15, 2014, due to a lack of specification changes that reduce hemolysis during blood sampling.

    Product
    Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M001454580, Rx ONLY, 2) 5F, UPN M001454630, Rx ONLY & 3) 6F, UPN M001454780, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for…
    Category
    Medical Device
    Distribution
    Distributed nationwide