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.

35426–35450 of 50504

  • HighFDA (Devices)·Z-1962-2016·2016-06-22

    Arthrex Recalls BioSync Anatomic Cotton Wedges Due to Polystyrene Particulate

    Arthrex, Inc. is recalling 138 BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices were distributed in 15 states.

    Product
    BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Food)·F-1447-2016·2016-06-22

    CSM Bakery TransSmart Brownie Cookies Recalled for Undeclared Peanut

    CSM Bakery Products NA is recalling TransSmart Brownie Cookies because they contain undeclared peanut protein. Consumers should not eat the product.

    Product
    TransSmart, Brownie Cookie, 300 1.2oz Cookies, Net Weight 22.5 lbs/10.22 kg.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1456-2016·2016-06-22

    CSM Bakery Recalls Macadamia Nut Cookies Due to Undeclared Peanut

    CSM Bakery Products NA is recalling frozen Macadamia Nut Cookies with White Drops because they contain undeclared peanut protein.

    Product
    Macadamia Nut Cookie with White Drops, TranSmart, Frozen Pre-cut Cookie Cough, Net Weight 22.5 lbs (10.22 kgs).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1521-2016·2016-06-22

    Harris Teeter Recalls 12 Inch Message Cookies Due to Undeclared Peanut

    Harris Teeter is recalling 12 Inch Message Cookies because they contain undeclared peanut protein. Consumers should not eat the product.

    Product
    12 Inch Message Cookies, UPC 0007203695587, 1 Pk (Pack 24/1 Ct)
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-1523-2016·2016-06-22

    Harris Teeter Recalls 12 Count Sugar Cookies for Undeclared Peanut Allergen

    Harris Teeter is recalling 12 Count Sugar Cookies because they contain undeclared peanut protein. Consumers with peanut allergies should not eat these products.

    Product
    12 Count Sugar Cookies, UPC 0007203695601, 12 Ct (Pack 25/12 Ct)
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1953-2016·2016-06-22

    Zimmer Trabecular Metal Implants Recalled for Sterility Concerns

    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
    TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR GRN SZ 5 12MM - 00588606512 TM MONO TIB STR GRN SZ 5 14MM - 00588606514 TM MONO TIB STR GRN SZ 5 17MM - 00588606517 TM MONO TIB STR GRN SZ 6 10MM - 00588606610 TM MONO TIB STR GRN SZ 6 12MM - 00588606612 TM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1469-2016·2016-06-22

    CSM Bakery Products Recalls Frozen Cookie Dough for Undeclared Peanut

    CSM Bakery Products is recalling specific lots of frozen pre-cut cookie dough because they contain undeclared peanut protein.

    Product
    Chocolate Chip with Colored Candy Pieces, Frozen Pre-cut Cookie Dough, Net Weight; 24.61 lbs/11.17 kgs. and 23.44 lbs/10.64 kgs.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1445-2016·2016-06-22

    CSM Bakery Recalls Cranberry Nut Crunch Cookie Dough for Undeclared Peanut

    CSM Bakery Products NA is recalling 4 oz. Cranberry Nut Crunch Cookie Dough due to undeclared peanut protein. The product was distributed in 20 US states and Colombia.

    Product
    4 oz. Cranberry Nut Crunch Cookie Dough, TransSmart, Net Weight 24 lbs (10.88 kg).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1496-2016·2016-06-22

    Ex-Seed Liquid Shortening Recalled for Foreign Material Contamination

    Oasis Trading Co. is recalling Ex-Seed Premium Creamy Liquid Shortening because 35 lb bottles were found to contain high density polyethylene resin trim rings.

    Product
    Ex-Seed Premium Creamy Liquid Shortening, Net Wt. 35 LB (15.88), Distributed by Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 18896 9
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1520-2016·2016-06-22

    Harris Teeter Oatmeal Raisin Walnut Cookies Recalled for Undeclared Peanut

    Harris Teeter is recalling Gourmet Oatmeal Raisin Walnut Cookies because they contain undeclared peanut protein. Consumers in seven states should not eat the product.

    Product
    Gourmet Oatmeal Raisin Walnut Cookies, UPC 0007203695193, 4 Ct (Pack 24/4 Ct)
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1976-2016·2016-06-22

    Navilyst Recalls Xcela PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling specific Xcela PICC catheters because they lack a manufacturing change that reduces the risk of hemolysis during blood sampling.

    Product
    Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965457440 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-2000-2016·2016-06-22

    Siemens Biograph mCT Scanner Recall Due to Unwelded Cover Bolts

    Siemens is recalling one Biograph mCT scanner because unwelded bolts on the cover-lifting bracket could cause the cover to fall during service.

    Product
    BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1468-2016·2016-06-22

    CSM Bakery Recalls White Chocolate Chip Fudge Cookies for Undeclared Peanut

    CSM Bakery Products NA is recalling TranSmart White Chocolate Chip Fudge Cookies because they contain undeclared peanut protein.

    Product
    TranSmart, White Chocolate Chip Fudge Cookie, 240 1.5 oz. Cookies, Net Weight: 22.5 lbs/10.21 kg.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1460-2016·2016-06-22

    CSM Bakery Products Recalls Frozen Cookie Dough for Undeclared Peanut

    CSM Bakery Products NA is recalling frozen pre-cut cookie dough because it contains undeclared peanut protein. Consumers should not eat the product.

    Product
    Sugar, Frozen Pre-cut Cookie Dough, Net Weight 24.61 lbs/11.16 kgs and 23.44 lbs/10.64 kgs.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-2002-2016·2016-06-22

    Datascope Small Patient ECC Pack Recalled for Excess Endotoxin

    Datascope Corporation is recalling 17 units of Small Patient ECC Packs due to endotoxin levels exceeding regulatory limits. The affected units were distributed in Georgia.

    Product
    Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1506-2016·2016-06-22

    Silver Source Creamy Fry Oil Recalled for Foreign Material

    Oasis Trading Co. is recalling Silver Source Creamy Fry Oil because bottles were found to contain high density polyethylene resin trim rings.

    Product
    Silver Source Creamy Fry Oil, Net Wt. 35 LB (15.88 kg), Distributed by: Performance Food Group, Richmond, VA 23238, UPC 00806795022360
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1988-2016·2016-06-22

    Navilyst Medical Recalls BioFlo Hybrid PICC Catheters with Valve Technology

    Navilyst Medical is recalling specific BioFlo Hybrid PICC catheters because they lack a manufacturing change that reduces hemolysis during blood sampling.

    Product
    BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458970, 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1491-2016·2016-06-22

    Pocahontas Clear Liquid Frying Shortening Recalled for Foreign Material

    Oasis Trading Co. is recalling 4,905 containers of Pocahontas Clear Liquid Frying Shortening because the product was reported to contain high density polyethylene resin trim rings.

    Product
    Pocahontas Clear Liquid Frying Shortening, Net Wt. 35 LB (15.88), Distributed by Progressive Group Alliance, Inc., Richmond, VA 23228, UPC 7 32146 18196 0
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1512-2016·2016-06-22

    Clight Lemon Tea Drink Mix Recalled for Undeclared Soy Lecithin

    Mondelez Puerto Rico is recalling Clight Lemon Tea drink mix because it contains soy lecithin that is not declared on the label.

    Product
    Label reads in part as: "Clight***T¿ Lim¿n*** Lemon Tea***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-1951-2016·2016-06-22

    Zimmer Trabecular Metal Implants Recalled for Sterility Concerns

    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 pouch barrier system.

    Product
    TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 00588604312 TM CR TIB SZ 3 C-H, 14MM - 00588604314 TM CR TIB SZ 3 C-H, 17MM - 00588604317 TM CR TIB SZ 4 C-H 10 MM - 00588604410 TM CR TIB SZ 4 C-H, 12MM - 00588604412 TM CR TIB SZ 4 C-H, 14MM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1997-2016·2016-06-22

    Siemens Biograph mCT Scanner Recall Due to Unwelded Cover Bolts

    Siemens is recalling one Biograph mCT scanner because unwelded bolts may cause the cover to fall during service.

    Product
    BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1977-2016·2016-06-22

    Navilyst Recalls Xcela Hybrid PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling specific Xcela Hybrid PICC catheters because they lack a manufacturing change that reduces hemolysis during blood sampling.

    Product
    Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965952410, 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