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.

34701–34725 of 50502

  • HighFDA (Food)·F-2124-2016·2016-09-21

    Panzanella Bread Recalled for Undeclared Soy and Wheat Allergens

    Golden Crown Bakery is recalling bread products due to undeclared soy and wheat allergens and missing ingredient labels.

    Product
    Ciros PAN Bread 3 lbs. SLC; No ingredient statement on label. No labeling agreement with consignees. Some of the packages list the name of the bread in the paper bag. The 3lb designation is for dough weight, not net wt. Sliced breads are individually wrapped in in plastic…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2116-2016·2016-09-21

    Hostess Zingers Vanilla cakes recalled for unlabeled peanut allergen

    Hostess Brands is recalling Zingers Vanilla cakes because they were made with flour containing peanut allergen but are not labeled as containing peanuts.

    Product
    Iced Vanilla cake with creamy filling, packaged as Hostess Zingers Vanilla in 10-ct multi-packs of individual cakes, net wt. 12.70oz (360 g), UPC 888109110598; 6-ct. single serving fun size snack packs, 3 cakes per pack net wt. 3.81 oz. (108g), UPC 888109010119 and 888109300029…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2170-2016·2016-09-21

    Mars Recalls Combos Pizzeria Pretzels for Undeclared Peanut Residue

    Mars Chocolate North America is recalling specific 15-ounce Combos Pizzeria Pretzels due to the potential presence of undeclared peanut residue.

    Product
    COMBOS SNACKS PIZZERIA PRETZEL - 15 OZ -Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC 41419780473
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2203-2016·2016-09-21

    China Garden Bourbon Sauce Recalled for Potential E. Coli Contamination

    Sunrise Foods Inc. is recalling China Garden Bourbon Sauce because the flour used in the product may be contaminated with E. Coli.

    Product
    China Garden Bourbon Sauce (for Chicken) 5.25 lb plastic bag Ingredients: SUGAR, OYSTER FLAVORED SAUCE***SWEET RICE, WATER, ALL PURPOSE FLOUR WHITE BLEACHED ENRICHED***DRIED YEAST. Contains: (Soy, Wheat). FOR INSTITUTIONAL USE ONLY SUNRISE FOODS, INC. COLS, OHIO 43204
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-2810-2016·2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 1,420 Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure Tubing, Reservoir, 03 mL Squeeze Flush and 2 Needleless Valves, Item No. 42646-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2174-2016·2016-09-21

    Mars Recalls Combos Snacks Pizzeria Pretzel for Undeclared Peanut Residue

    Mars Chocolate North America is recalling Combos Snacks Pizzeria Pretzel due to potential undeclared peanut residue. The recall covers 183,678 cases distributed nationwide and to foreign markets.

    Product
    COMBOS SNACKS PIZZERIA PRETZEL Net Wt. 1.80 oz. (51 g) Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC 41419714751
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2137-2016·2016-09-21

    Gasco Industrial Recalls Soy Sauce Due to Undeclared Wheat

    Gasco Industrial is recalling 1,146 gallons of soy sauce distributed in Puerto Rico and Saint Berthelemy because the product contains undeclared wheat.

    Product
    Label reads in part as: "BELCA***Soy Sauce***HECHO EN PUERTO RICO (Made in Puerto Rico)***Contenido Neto (Net Content): Un Gal¿n (one gallon)***128 fl. oz***DISTRIBUIDO POR (Distributed by): MISTER PRICE INC. SAN JUAN, PR 00936".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2256-2016·2016-09-21

    Misono Food Ltd Recalls Smoked Herring Roe for HACCP Violations

    Misono Food Ltd is recalling smoked herring roe produced in Norway because the foreign processor failed to meet HACCP requirements. The product was distributed to one retailer in New York City.

    Product
    Smoked Herring Roe, Salted and smoked herring roe, Net weight 0.152 (others may vary slightly), Produced by: Njardar AS 6094 Leinoy, Product of Norway
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2811-2016·2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV Monitoring Kits because the SafeSet Reservoir and blood sampling components may leak.

    Product
    Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24" Tubing, Disposable Transducer, 03 mL Squeeze Flush, Macrodrip (Patient Mount), Item No. 42648-06 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2803-2016·2016-09-21

    Siemens RAPIDLab 1265 Blood Gas Analyzer Recalled for Data Mismatch

    Siemens is recalling RAPIDLab 1265 Blood Gas Analyzers because patient names may be printed with data from a different patient.

    Product
    RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 10470366, 10491395
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2797-2016·2016-09-21

    Siemens RAPIDPoint 400 Blood Gas Analyzer Recalled for Patient Data Mismatch

    Siemens is recalling 492 RAPIDPoint 400 Blood Gas Analyzers because patient names may be printed with data from a different patient.

    Product
    Siemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material Number (SMN): 10291507,10314585, 10318899,10321239,10322654,10324081, 10328803, 10331381 , 10339634
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2826-2016·2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Monitoring Kit with 03 ml Squeeze Flush, SafeSet Reservoir, 2 Needleless Valves, Mounts and Bracket, Item Nos. 46107-35, 46110-07 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2809-2016·2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Monitoring Kit with 2 SafeSet Reservoir and 2 Blood Sampling Ports, 84" Tubing, Disposable Transducer, 3 mL Squeeze Flush, Macrodrip (Pole Mount), Item No. 42646-06 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2238-2016·2016-09-21

    Haitai Recalls Matdongsan Peanut Crunch Snack for Undeclared Soy

    Haitai is recalling Matdongsan Peanut Crunch Snack because it contains undeclared soy lecithin. The recall affects specific lot codes distributed across 18 states.

    Product
    Matdongsan Peanuts Crunch Snack, Net Wt. 80g, 325g
    Category
    Food
    Distribution
    18 states
  • HighFDA (Devices)·Z-2822-2016·2016-09-21

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 10 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2817-2016·2016-09-21

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 110 units of Double Kit with SafeSet and 03mL Flush Device due to a potential for leak.

    Product
    Double Kit with SafeSet and 03mL Flush Device, Item No. 46080-37 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2177-2016·2016-09-21

    Mars Recalls Combos Pepperoni Pizza Crackers for Undeclared Peanut Residue

    Mars Chocolate North America is recalling Combos Pepperoni Pizza Crackers due to the potential for undeclared peanut residue. The recall affects 183,678 cases distributed nationwide and in foreign markets.

    Product
    COMBOS PEPPERONI PIZZA CRACKER - Net Wt. 1.70 OZ (48.2 g) Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC 41419714737
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2123-2016·2016-09-21

    Hostess Donettes Maple Glazed Mini Donuts Recalled for Peanut Allergen

    Hostess Brands is recalling Donettes Maple Glazed Mini Donuts because the product contains peanut allergen but is not labeled to contain peanuts.

    Product
    Hostess Donettes Maple Glazed Mini Donuts, packaged in 9-17-ct bagsof mini donuts, net wt. 10.50oz, UPC 888109111243; the most responsible firm name on the label is Hostess Brands LLC, Kansas City, MO 64141.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2830-2016·2016-09-21

    C.R. Bard Recalls Option-vf Urinary Catheters Due to Sterility Concerns

    C.R. Bard is recalling 274 units of Option-vf Urinary Catheters because an FDA inspection found them to be potentially nonsterile.

    Product
    Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Food)·F-2135-2016·2016-09-21

    Best Foods Recalls Deer Cumin Powder for Undeclared Peanut

    Best Foods NJ, Inc. is recalling Deer Cumin Powder because it may contain undeclared peanut. The product was distributed to several states.

    Product
    Deer Cumin Powder 7 oz.., UPC 714760027497 14 oz UPC 714760027503 Packed for: Best Foods Inc. Edison, NJ 08817
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2800-2016·2016-09-21

    Siemens RAPIDLab 1240 Blood Gas Analyzer Recalled for Patient Data Mismatch

    Siemens is recalling 144 RAPIDLab 1240 Blood Gas Analyzers because patient names may be printed with data from a different patient.

    Product
    Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 10321840, 10491392
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2175-2016·2016-09-21

    Mars Recalls Combos Pretzels for Undeclared Peanut Residue

    Mars Chocolate North America is recalling Combos Buffalo Blue Cheese Pretzels due to potential undeclared peanut residue.

    Product
    COMBOS SNACK BUFFALO BLUE CHEESE PRETZEL - Net Wt. 1.80 (51 g) oz Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC 41419474303
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2812-2016·2016-09-21

    ICU Medical Recalls Transpac IV Trifurcated Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 760 Transpac IV Trifurcated Monitoring Kits because of a potential for leaks in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports, 84", 3.3mL Squeeze Flushes, 3 Disposable Transducers, Macrodrip (Pole Mount), Item No. 42650-06 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2819-2016·2016-09-21

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 125 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    SafeSet Kit with 30 mL Flush Device, Item No. 46083-42 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2785-2016·2016-09-21

    Allergy Laboratories Recalls Sterile Empty Vials Due to Glass Particles

    Allergy Laboratories is recalling 81,625 sterile empty vials distributed in North Carolina due to a potential for glass particles within the vials.

    Product
    GREER 2 ML Sterile Empty Vials 2-13 vial 25 ea - Silver Cap
    Category
    Medical Device
    Distribution
    1 state