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.

34676–34700 of 50502

  • HighFDA (Devices)·Z-2801-2016·2016-09-21

    Siemens RAPIDLab 1245 Blood Gas Analyzer Recalled for Data Mismatch

    Siemens is recalling 197 RAPIDLab 1245 Blood Gas Analyzers because patient names may be printed with data from a different patient.

    Product
    RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2824-2016·2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 100 units of Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential leak hazard.

    Product
    Transpac IV Monitoring Kit with SafeSet 84" Arterial Pressure Tubing, Reservoir, Squeeze Flush and Needleless Valve, Item No. 46104-53 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2042-2016·2016-09-21

    Panzanella Bread Recalled for Undeclared Soy and Wheat Allergens

    Golden Crown Bakery is recalling Panzanella Italian Peasant Bread due to undeclared soy and wheat allergens and missing product labeling.

    Product
    Label reads in part "***Panzanella Bread Company Italian Peasant Bread 24 oz. ***INGREDIENTS: Unbleached enriched wheat flour (Niacin, reduced iron, thiamine mononitrate, riboflavin, frolic acid, enzyme, ascorbic acid [dough conditioner]), Sea Salt (Salt, magnesium carbonate)…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2200-2016·2016-09-21

    National Frozen Foods Recalls IQF Peas and Carrots for Listeria Risk

    National Frozen Foods Corporation is recalling approximately 665,858 lbs of Not Ready to Eat IQF Peas and Carrots due to potential Listeria monocytogenes contamination.

    Product
    Not Ready to Eat, IQF Peas and Carrots. Products' labels contains Cooking Instructions. Bountiful Harvest Peas & Carrots, item # 22486-11902, case & label UPC 30822486119028, Net wt. 12/2.5 LB Bountiful Harvest Peas & Carrots, item # 22486-11913, case & label UPC…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2120-2016·2016-09-21

    Hostess Donettes Double Chocolate Mini Donuts Recalled for Peanut Allergen

    Hostess Brands is recalling Donettes Double Chocolate Mini Donuts because the flour used contains peanut allergen, which is not listed on the label.

    Product
    Hostess Donettes Double Chocolate Mini Donuts, packaged in 9-ct bags of mini donuts, net wt. 11.25 oz, UPC 888109150037, the most responsible firm name on the label is Hostess Brands, LLC in Kansas City,MO 64141.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2167-2016·2016-09-21

    Mars Recalls Combos Cheddar Cheese Crackers for Undeclared Peanut Residue

    Mars Chocolate North America is recalling Combos Cheddar Cheese Crackers due to the potential for undeclared peanut residue.

    Product
    COMBOS CHEDDAR CHEESE CRACKER - Net Wt. 6.30 oz (178.6 g) Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC USPC 41419420072
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2121-2016·2016-09-21

    Hostess Crunch Mini Donuts Recalled for Unlabeled Peanut Allergen

    Hostess Brands is recalling Crunch Mini Donuts because they were manufactured with flour containing peanut allergen but are not labeled to contain peanuts.

    Product
    Crunch Mini Donuts, packaged in 6-14-ct and 9-14-ct bags of mini donuts as Hostess Donettes Crunch Mini Donuts, net wt. 9.5oz, UPC 888109110642; packaged in 9-17-ct bags of mini donuts as Hostess Donettes Crunch Mini Donuts, net wt. 10.5oz, UPC 888109110659; packaged in 6ct…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2795-2016·2016-09-21

    T2 Biosystems Recalls T2Candida Cartridges Due to Invalid Results

    T2 Biosystems is recalling T2Candida Cartridges because they produced elevated levels of invalid results. The recall affects 6,864 units distributed to 17 states.

    Product
    T2Candida¿Cartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534 (individual cartridge base). A qualitative T2 Magnetic Resonance (T2MR¿) assay for the direct detection of Candida species in EDTA human whole blood specimens.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Food)·F-2126-2016·2016-09-21

    Panzanella Bread Recalled for Undeclared Soy and Wheat Allergens

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

    Product
    Mini Roll Tondo 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 and labeled…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2115-2016·2016-09-21

    Hostess Zingers Recalled for Unlabeled Peanut Allergen

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

    Product
    Iced Devil's Food cake with creamy filling, packaged as Hostess Zingers in 10-ct multi-packs of individual cakes, net wt. 12.70oz (360 g), UPC 888109110581; 6-ct. single serving fun size snack packs, individual pack net wt. 2.55 oz (72 g), UPC 888109010027;with the responsible…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2821-2016·2016-09-21

    ICU Medical Recalls Pediatric Pressure Transducer Kits Due to Leak Risk

    ICU Medical is recalling 20 Pediatric Kits with 30mL Flush Devices due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Pediatric Kit with 30mL Flush Device, Item No. 46099-10 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-2828-2016·2016-09-21

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Potential

    ICU Medical is recalling 20 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and Needleless Valve, Item No. 46112-65 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2245-2016·2016-09-21

    Gardner Pie Company Recalls Cheesecakes Due to Peanut Contamination

    Gardner Pie Company is recalling 1,109 cheesecakes because the graham cracker crumbs used in the crust may contain peanut residue.

    Product
    Product is a 29-ounce/9" cheesecake packed in a cardboard carton in an aluminum pie pan with a plastic dome lid. Pies for further distribution are packed in a master case, 8 units per case. The brand name on the case is Gardner Pie Company Akron, OH. The ingredient statement…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2173-2016·2016-09-21

    Mars Recalls Combos Caramel Creme Pretzels for Undeclared Peanut Residue

    Mars Chocolate North America is recalling specific lots of Combos Sweet and Salty Caramel Creme Pretzels due to potential undeclared peanut residue.

    Product
    COMBOS SWEET AND SALTY CARAMEL CREME PRETZEL Net Wt. 6.0 oz (170.1g) Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC 41419780879
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2114-2016·2016-09-21

    Hostess Ding Dongs Recalled for Unlabeled Peanut Allergen

    Hostess Brands is recalling specific lots of Ding Dongs because they were made with flour containing peanut allergen but are not labeled to contain peanuts.

    Product
    Hostess Ding Dongs, chocolate cake with creamy filing, packaged in 10-ct multi-packs of individual cakes, net wt. 12.70oz (360 g), UPC 888109110611; and 6-ct. single serving fun size snack packs, individual pack net wt. 2.55 oz (72 g), UPC 888109010027. The responsible firm…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2807-2016·2016-09-21

    ICU Medical Recalls Transpac IV Bifurcated Kits Due to Leak Risk

    ICU Medical is recalling 10 units of Transpac IV Bifurcated Kits with SafeSet Reservoirs due to a potential for leaks.

    Product
    Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 42500-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2239-2016·2016-09-21

    Whole Foods Market Thai Shrimp Salad Recalled for Undeclared Allergens

    Whole Foods Market is recalling Thai Shrimp Salad in the Northeast region because it was mislabeled, containing undeclared salmon and pistachios.

    Product
    Whole Food Market Thai Shrimp Salad Serving Size 8 oz. Distributed by Whole Foods Market Englewood Cliffs NJ 07632 UPC 8-2510-00081
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2041-2016·2016-09-21

    Panzanella Bread Recalled for Undeclared Soy and Wheat Allergens

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

    Product
    Caraway Multigrain PAN Bread 3 lbs. SLC; The 3lb designation is for dough weight, not net wt. No ingredient statement on label. No labeling agreement with consignees. Sliced breads are individually wrapped in in plastic and labeled only with a label that shows the…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2814-2016·2016-09-21

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Potential

    ICU Medical is recalling 20 units of Single Monitoring Kits with 30mL Flush Devices due to a potential for leak in the SafeSet Reservoir and blood sampling components.

    Product
    Single Monitoring Kit with 30mL Flush Device, Item No. 46073-38 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-2818-2016·2016-09-21

    ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits

    ICU Medical is recalling 70 units of SafeSet Reservoir and blood sampling kits due to a potential leak.

    Product
    Monitoring Kit with 03mL Flush Device, Item No. 46080-57 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 (Food)·F-2118-2016·2016-09-21

    Hostess Chocolate Frosted Mini Donuts Recalled for Peanut Allergen Mislabeling

    Hostess Brands is recalling Chocolate Frosted Mini Donuts because they were manufactured with flour containing peanut allergen but are not labeled to contain peanuts.

    Product
    Chocolate Frosted Mini Donuts, packaged in 6-20ct and 9ct bags of mini donuts as Hostess Donettes Frosted Mini Donuts, net wt. 11.25oz, UPC 888109150020; packaged in 9ct bags of mini donuts as Hostess Donettes Frosted Mini Donuts, net wt. 14.07oz, UPC 888109110239; packaged in…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1499-2016·2016-09-21

    Aurobindo Recalls Pantoprazole Tablets Due to Foreign Tablet Presence

    Aurobindo Pharma USA is recalling specific bottles of Pantoprazole Sodium Delayed-Release Tablets because a foreign tablet was found inside the container.

    Product
    Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo Pharma USA, Inc 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit-VII (SE2), Mahaboob Nagar (Dt) - 509302, India , NDC…
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-2816-2016·2016-09-21

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 150 units of SafeSet Reservoir kits with Transpac IV transducers due to a potential for leak.

    Product
    Triple Line SafeSet Kit with 03mL Flush Device, Item No. 46076-27 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 (Devices)·Z-2832-2016·2016-09-21

    Circulatory Technology Recalls Bigger-Better-Bladder 2 Devices Due to Seal Leak

    Circulatory Technology Inc is recalling 20 units of the Bigger-Better-Bladder, TM 2 device because the seal between the balloon and housing may leak.

    Product
    The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2831-2016·2016-09-21

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

    C.R. Bard is recalling 274 units of Option-vm Urinary Catheters because an FDA inspection found them potentially nonsterile. The devices were distributed to 15 states.

    Product
    Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
    Category
    Medical Device
    Distribution
    15 states