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.

34651–34675 of 50502

  • HighFDA (Devices)·Z-2796-2016·2016-09-21

    Merge Healthcare Recalls RadSuite Software Due to Missing Studies

    Merge Healthcare is recalling RadSuite software versions where studies may be missing from archives before watermarking.

    Product
    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2799-2016·2016-09-21

    Siemens RAPIDPoint 500 Blood Gas Analyzer Recalled for Data Mismatch

    Siemens Healthcare Diagnostics Inc is recalling 6,786 RAPIDPoint 500 Blood Gas Analyzers because patient names may be printed with data from a different patient.

    Product
    Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730, 10696855, 10696857, 10697306
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2176-2016·2016-09-21

    Mars Recalls Combos Snacks Cheddar Cheese Pretzels for Undeclared Peanut Residue

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

    Product
    COMBOS SNACKS CHEDDAR CHEESE PRETZEL - Net Wt. 1.80 OZ (51 g) Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA 41419714713
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2129-2016·2016-09-21

    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
    Rustic Roll; 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-2132-2016·2016-09-21

    Panzanella Bread Recalled for Undeclared Soy and Wheat Allergens

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

    Product
    Three Seed - PAN 3 lbs. SLC Bread 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…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2168-2016·2016-09-21

    Mars Recalls Combos Pepperoni Crackers for Undeclared Peanut Residue

    Mars Chocolate North America is recalling Combos Pepperoni Crackers due to potential undeclared peanut residue. The recall covers 183,678 cases distributed nationwide and abroad.

    Product
    COMBOS PEPPERONI CRACKER - Net Wt. 1.70 oz. (48.2 g) Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC 41419420089
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2813-2016·2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 90 units of Transpac IV Trifurcated Monitoring Kits due to a potential for leaks in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valves, Item No. 42650-66 Product 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-2206-2016·2016-09-21

    Sunrise Foods Recalls National Food Group Bourbon Sauce Due to E. Coli Risk

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

    Product
    National Food Group Bourbon Sauce 5.25 lb plastic bag Ingredients: Sugar, Oyster Flavored Sauce***All purpose Flour White Bleached Enriched***Dried Yeast. Contains: (Wheat) FOR INSTITUTIONAL USE ONLY Prepared for: National Food Group, Novi MI UPC 8 12177 01154 9
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-2802-2016·2016-09-21

    Siemens RAPIDLab 1260 Blood Gas Analyzer Recalled for Data Mismatch

    Siemens is recalling 114 RAPIDLab 1260 Blood Gas Analyzers because patient names may be printed with data from different patients.

    Product
    RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2169-2016·2016-09-21

    Mars Recalls Combos Pretzels for Potential Undeclared Peanut Residue

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

    Product
    COMBOS BUFFALO BLUE CHEESE PRETZEL Net Wt.6.30 oz (178.6 g)Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC 4141420119
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2806-2016·2016-09-21

    ICU Medical Recalls Transpac IV Trifurcated Kits Due to Leak Risk

    ICU Medical is recalling 250 units of Transpac IV Trifurcated Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports, 84 inch Tubing, 3 3 ml Intraflo Flushes, 3 Disposable Transducers, Macrodrip, Item No. 42500-04 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2825-2016·2016-09-21

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 140 units of TP4 Kits with SafeSet Reservoirs due to a potential for leaks. The affected medical devices were distributed nationwide.

    Product
    TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Admin Set, Item No. 46104-65 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2178-2016·2016-09-21

    Mars Recalls Combos Cheddar Cheese Crackers for Undeclared Peanut Residue

    Mars Chocolate North America is recalling specific Combos Cheddar Cheese Crackers due to potential undeclared peanut residue. Consumers should check their packages for the listed codes.

    Product
    COMBOS SNACKS CHEDDAR CHEESE CRACKER - Net. Wt. 1.70 oz (48.2g) Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC 41419714744
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2789-2016·2016-09-21

    Stryker Patella Assembly Instrument Recalled for Component Disassociation Risk

    Stryker Howmedica Osteonics is recalling 2,039 units of the Scorpio Patella Assembly Instrument because press-fit failures could cause clamping components and pins to disassociate.

    Product
    Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembly Instrument is used during total knee replacement surgery for the implantation of Scorpio Patella implant components. The device functions to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2113-2016·2016-09-21

    Hostess Chocodile Twinkies Recalled for Unlabeled Peanut Allergen

    Hostess Brands is recalling Chocodile Twinkies because the product was manufactured with flour containing peanut allergen but is not labeled to contain peanuts.

    Product
    Hostess Chocodile Twinkies, chocolate covered sponge cake with creamy filling, packaged in 9-ct multi-packs of individual cakes, net wt. 13.02 oz (396 g), UPC 888109110499; and 6-ct. single serving fun size snack packs, individual pack net wt. 2.89 oz (82 g), UPC 888109010492.…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2788-2016·2016-09-21

    Howmedica Recalls AccuLIF PL Cages Due to Height Reduction

    Howmedica Osteonics Corp. is recalling AccuLIF PL Cages because some implants have shown a reduction in height greater than 1 mm.

    Product
    AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2131-2016·2016-09-21

    Panzanella Bread Recalled for Undeclared Soy and Wheat Allergens

    Golden Crown Bakery is recalling specialty sandwich breads due to undeclared soy and wheat and missing ingredient labels.

    Product
    Specialty Sandwich Bread 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…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2798-2016·2016-09-21

    Siemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Data Mismatch

    Siemens is recalling RAPIDPoint 405 Blood Gas Analyzers because patient names may be printed with results from a different patient.

    Product
    Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2197-2016·2016-09-21

    National Frozen Foods Recalls IQF Green Peas for Listeria Risk

    National Frozen Foods Corporation is recalling not-ready-to-eat IQF green peas due to potential Listeria monocytogenes contamination. The products are sold under various brands nationwide and in Canada and Japan.

    Product
    Not Ready to Eat, IQF green peas. Products' labels contains Cooking Instructions. Products are sold under various brands and various net weight. Bountiful Harvest Green Peas, item # 22486-11904, case UPC & label UPC 30822486119042 and 2248611904, net wt. 12/2.5 LB…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2275-2016·2016-09-21

    Ajinomoto Recalls Cheese Sticks Due to E. coli O121 Contamination Risk

    Ajinomoto Windsor is recalling specific cheese stick products because they may be contaminated with E. coli O121. The recall covers 2,962 cases distributed across multiple US states.

    Product
    Molly's Kitchen Hotzzarella Cheese Sticks, 12 lbs., Item No. 582648; Fred's Hotzzarella Cheese Sticks, 12lbs., Item No. 0204320.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Food)·F-2127-2016·2016-09-21

    Panzanella Bread Recalled for Undeclared Soy and Wheat Allergens

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

    Product
    Palline Integrale; and Pane Integrale PAN 3 lbs. SLC Bread 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…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2199-2016·2016-09-21

    Sysco Classic Peas and Onions Recalled for Listeria Risk

    National Frozen Foods Corporation is recalling Sysco Classic Peas and Onions due to potential Listeria monocytogenes contamination.

    Product
    Not Ready to Eat, IQF Sysco Classic Peas & Onions, NFFC item number 74865-12430. Products' labels contains Cooking Instructions. Net Weight 2.5 lbs. CASE UPC 100074865 124307
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2827-2016·2016-09-21

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

    ICU Medical is recalling 150 units of Transpac IV Trifurcated Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir, Port and 03 ml Squeeze Flush Devices, Item No. 46110-84 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2180-2016·2016-09-21

    Mars Recalls Combos Cheddar Cheese Pretels for Undeclared Peanut Residue

    Mars Chocolate North America is recalling Combos Cheddar Cheese Pretels due to potential undeclared peanut residue. The recall covers 183,678 cases distributed nationwide and abroad.

    Product
    COMBOS SNACKS CHEDDAR CHEESE PRETZEL - Net Wt. 1.70 OZ (51 g) Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC 41419714744
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2204-2016·2016-09-21

    Sunrise Foods Recalls Jump Dark Stir Fry Sauce Due to E. Coli Risk

    Sunrise Foods Inc is recalling Jump Dark Stir Fry Sauce because the flour used in the product may be contaminated with E. Coli.

    Product
    Jump Dark Stir Fry Sauce .5 gallon plastic bag Ingredients: WATER, SOY SAUCE***OYSTER FLAVORED SAUCE***MUSHROOM SOY SAUCE***SOYBEAN OIL***ALL PURPOSE FLOUR WHITE BLEACHED ENRICHED***DRIED YEAST. Contains: (Soy, Wheat). FOR INSTITUTIONAL USE ONLY JUMP PROPRIETARY PRODUCT Prepared…
    Category
    Food
    Distribution
    16 states