September 2016 recalls

734 recalls were announced in September 2016.

What the numbers show

Critical: 91
Severe: 189
High: 306
Moderate: 125
Low: 23

Of the 734 recalls this month scored against our rubric, 12% are Critical, 26% are Severe.

Which agencies issued them

301–400 of 734

HighFDA (Food)·F-2133-2016·2016-09-21
Panzanella Bread Recalled for Undeclared Soy and Wheat Allergens
Golden Crown Bakery is recalling Tramezzino bread products in Washington State due to undeclared soy and wheat allergens and missing ingredient labels.
Product
Tramezzino - PAN 3 lbs. SLC Bread; Tramezzino - PAN 3 lbs. Whole 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…
Category
Food
Distribution
0 states
HighFDA (Food)·F-2244-2016·2016-09-21
Gardner Pie Company Recalls Key Lime Pies Due to Peanut Contamination
Gardner Pie Company is recalling 163 key lime pies sold in Ohio because the graham cracker crumbs used in the crust may contain peanut residue.
Product
Product is a 32-ounce Key Lime pie sold at the firm's retail outlet only. Pie is packed in a cardboard carton with an aluminum pie pan and a plastic dome lid. Retail pie is not labeled. Customers are provided the flavor of pie they select for purchase.
Category
Food
Distribution
1 state
HighFDA (Food)·F-2090-2016·2016-09-21
Country Home Bakers Recalls Cookie Dough Due to Metal Shavings
Country Home Bakers is recalling All Natural Chocolate Chunk with Salty Caramel Cookie Dough because metal shavings were found in the product.
Product
Country Home Bakers, All Natural Chocolate Chunk with Salty Caramel Cookie Dough, Net Wt: 22.5 lbs (10.2 kg), Count: 240-1.5oz (43g) portions, Country Home Bakers, Atlanta, GA 30310, ready to bake.
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-2808-2016·2016-09-21
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling specific Transpac IV Monitoring Kits because of a potential for leaks in the SafeSet Reservoir and blood sampling components.
Product
Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING, Disposable Transducer, 3 ML Intraflo Flush, Macrodrip (Pole Mount), Item No. 42619-08 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-2207-2016·2016-09-21
Sunrise Foods Spicy General Tso Sauce Recalled for E. Coli Risk
Sunrise Foods is recalling Pre-Thickened Spicy General Tso Sauce because the flour used in the product may be contaminated with E. Coli.
Product
Sunrise Foods Pre-Thickened Spicy General Tso Sauce 5 lb plastic bag Ingredients: WATER, SOY SAUCE***SOYBEAN OIL, SWEET RICE***ALL PURPOSE FLOUR WHITE BLEACHED ENRICHED***DRIED YEAST. Contains: (Soy, Wheat) FOR INSTITUTIONAL USE ONLY SUNRISE FOODS, INC. COLS, OHIO 43204 UPC 8…
Category
Food
Distribution
16 states
HighFDA (Devices)·Z-2786-2016·2016-09-21
Howmedica Recalls AccuLIF PL Spinal Cages Due to Height Reduction
Howmedica Osteonics Corp. is recalling AccuLIF PL spinal cages because some implants have shown a reduction in height greater than 1 mm after surgery.
Product
AccuLIF PL 6-9mm 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-2198-2016·2016-09-21
National Frozen Foods Recalls Mixed Vegetables for Listeria Risk
National Frozen Foods Corporation is recalling IQF Mixed Vegetables due to potential Listeria monocytogenes contamination. The products were distributed in the US, Canada, and Japan.
Product
Not Ready to Eat, IQF Mixed Vegetables. Products' labels contains Cooking Instructions. Products are sold under various brands and various net weight. Heinz Mixed Vegetables 02521-39698 14902521396989 4902521396982 12/1 KG Heinz Mixed Vegetables 02521-39698…
Category
Food
Distribution
Distributed nationwide
HighCPSC·16268·2016-09-21
Lenny Lamb Buckle Onbu Infant Carriers Recalled for Fall Hazard
Lenny Lamb is recalling Buckle Onbu infant carriers because missing internal stitching creates a fall hazard for children. No injuries have been reported.
Product
Buckle Onbu infant carriers
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Food)·F-2140-2016·2016-09-21
Bake'n Joy Sanding Sugar Recalled for Potential Metal Fragments
Bake'n Joy Foods is recalling 16-lb pails of sanding sugar due to potential metal fragments from a supplier.
Product
Bake'n Joy Sanding Sugar Net Wt. 16 lbs. pail Product Number: 0209416
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-2820-2016·2016-09-21
ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk
ICU Medical is recalling 20 units of Bifurcated SafeSet Kits with 03mL Flush Devices due to a potential for leaks.
Product
Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75 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-2237-2016·2016-09-21
SimplyNature Organic Chipotle Ranch Dressing Recalled for Undeclared Wheat
Drews LLC is recalling SimplyNature Organic Chipotle Ranch Dressing because it contains undeclared wheat. The product was distributed in five states.
Product
SimplyNature Organic Chipotle Ranch Dressing, Net Wt. 12 FL OZ (354mL), UPC: 0 41498 21862 1
Category
Food
Distribution
5 states
HighFDA (Food)·F-2179-2016·2016-09-21
Mars Recalls Combos Pizzeria Pretzels for Undeclared Peanut Residue
Mars Chocolate North America is recalling Combos Pizzeria Pretzels due to potential undeclared peanut residue. The recall affects 183,678 cases distributed nationwide and in foreign markets.
Product
COMBOS 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-2165-2016·2016-09-21
Mars Recalls Combos Cheddar Cheese Pretzels for Undeclared Peanut Residue
Mars Chocolate North America is recalling Combos Cheddar Cheese Pretzels due to the potential for undeclared peanut residue.
Product
COMBOS CHEDDAR CHEESE PRETZEL Net Wt. 6.30 oz (178.6 g) Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC 41419420058
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-2171-2016·2016-09-21
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 affects 183,678 cases distributed nationwide and abroad.
Product
COMBOS SNACKS CHEDDAR CHEESE PRETZEL - 15 OZ - Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC 41419780480
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-2125-2016·2016-09-21
Panzanella Bread Recalled for Undeclared Soy and Wheat Allergens
Golden Crown Bakery is recalling all bread products due to undeclared soy and wheat and missing labels.
Product
Frusta aka Italian Peasant 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-2139-2016·2016-09-21
Gasco Industrial Recalls NuChef Soy Sauce Due to Undeclared Wheat
Gasco Industrial is recalling 154 units of NuChef Soy Sauce because the product contains undeclared wheat. The recall affects Puerto Rico and Saint Berthelemy.
Product
Label reads in part as: "NuChef Soy Sauce***Contenido Neto (Net Content): 1 Gal¿n (1 Gallon) (128 fl. oz.)***P.O. Box 10718, San Juan PR 00922-0712 Tel. (787) 781-7950 Packed for Northwestern Selecta Made in USA***".
Category
Food
Distribution
1 state
HighFDA (Food)·F-2205-2016·2016-09-21
Sunrise Foods Recalls Jump Dark Teriyaki Sauce Due to E. Coli Risk
Sunrise Foods Inc is recalling Jump Dark Teriyaki Sauce because the flour used in the product may be contaminated with E. Coli.
Product
Jump Dark Teriyaki Sauce .5 gallon plastic bag Ingredients: WATER, SUGAR, SOY SAUCE***ALL PURPOSE FLOUR WHITE BLEACHED ENRICHED***DRIED YEAST. Contains: (Soy, Wheat) FOR INSTITUTIONAL USE ONLY Prepared for Jump International HIllard, Ohio 43026 UPC 8 56460 00114 5
Category
Food
Distribution
16 states
HighFDA (Devices)·Z-2805-2016·2016-09-21
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 420 Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential leak. The affected units were distributed nationwide in the US.
Product
Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves, Item No. 011-42646-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-2163-2016·2016-09-21
Baptista's Bakery Recalls Snack Factory Pretzel Crisps for Undeclared Milk Allergen
Baptista's Bakery is recalling Snack Factory Pretzel Crisps Original because a consumer reported the product contained seasoned items with undeclared milk.
Product
Snack Factory , Pretzel Crisps Original, UPC 049508006008, 7.2 oz (204g).
Category
Food
Distribution
1 state
HighFDA (Food)·F-2122-2016·2016-09-21
Hostess Donettes Glazed Mini Donuts Recalled for Unlabeled Peanut Allergen
Hostess Brands is recalling Donettes Glazed Mini Donuts because the flour used contains peanut allergen, which is not listed on the label.
Product
Hostess Donettes Glazed Mini Donuts, packaged in 9-17-ct and 6-17-ct bags of mini donuts, net wt. 10.50oz, UPC 888109110659;the most responsible firm name on the label is Hostess Brands, LLC, Kansas City, MO 64141.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-2119-2016·2016-09-21
Hostess Donettes Powdered Mini Donuts Recalled for Peanut Allergen Mislabeling
Hostess Brands is recalling Donettes Powdered Mini Donuts because they were manufactured with flour containing peanut allergen but are not labeled to contain peanuts.
Product
Hostess Donettes Powdered Mini Donuts, packaged in 9ct and 6-20ct bags of mini donuts, net wt. 10.5oz, UPC 888109150044; packaged in 9ct bag of mini donuts, net wt. 13.16oz, UPC 888109110246; packaged in 6ct single serve packages, net wt. 3oz, UPC 888109050047; the most…
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-2128-2016·2016-09-21
Panzanella Bread Recalled for Undeclared Soy and Wheat Allergens
Golden Crown Bakery is recalling Panino Tondo and Small Tondo Bread due to undeclared soy and wheat allergens and missing ingredient labels.
Product
Panino Tondo; and Small Tondo 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 (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
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
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
HighFDA (Food)·F-2172-2016·2016-09-21
Mars Recalls Combos Cheddar Cheese Crackers for Undeclared Peanut Residue
Mars Chocolate North America is recalling Combos Cheddar Cheese Crackers due to potential undeclared peanut residue.
Product
COMBOS SNACKS CHEDDAR CHEESE CRACKER - 15 OZ Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC 41419780497
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2815-2016·2016-09-21
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
Monitoring Kit with 30mL Flush Device, Item No. 46076-15 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-2787-2016·2016-09-21
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 after surgery.
Product
AccuLIF PL 8-12mm 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

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