November 2018 recalls

846 recalls were announced in November 2018.

What the numbers show

Critical: 142
Severe: 250
High: 301
Moderate: 124
Low: 29

Of the 846 recalls this month scored against our rubric, 17% are Critical, 30% are Severe.

Which agencies issued them

701–800 of 846

HighFDA (Food)·F-0349-2019·2018-11-07
Melissa's Hatch Chile Clean Snax Recalled for Missing Peanut Allergen Labeling
World Variety Produce is recalling Melissa's Hatch Chile Clean Snax because peanuts are listed in ingredients but not in the allergen information.
Product
Melissa's Hatch Chile Clean Snax, with Chia and flaxseed; 6.5 oz. plastic clamshell tub. Ingredients: Peanuts, Almonds, Cashews, Flaxseed, White Sesame Seeds, Evaporated Cane Juice, Green Match Chile Powder, Chia Seeds, Rice Syrup (Rice, Rice Milk Water), S=Honey, Sea, Salt.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0292-2019·2018-11-07
CMP Industries Recalls Dental Resin Liquid Due to Foreign Material
CMP Industries is recalling specific lots of Impak Elastic Acrylic Resin Liquid because foreign material was found in the product.
Product
IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0334-2019·2018-11-07
Buddy's Kitchen Recalls Beef Barbacoa on Telera Due to Contamination Risk
Buddy's Kitchen is recalling Beef Barbacoa on Telera due to potential Listeria or Salmonella contamination linked to a McCain Foods recall.
Product
Beef Barbacoa on Telera, Item 70663. Net Weight 13.92 lbs. 33 - 6.75 oz. portions. Keep Frozen. For institutional use only. Buddy's Kitchen, Inc., Burnsville, MN 55337
Category
Food
Distribution
8 states
HighFDA (Food)·F-0333-2019·2018-11-07
Buddy's Kitchen Recalls Beef Barbacoa Panini Focaccia for Listeria or Salmonella Risk
Buddy's Kitchen is recalling Beef Barbacoa on Panini Focaccia due to potential Listeria or Salmonella contamination linked to a McCain Foods recall.
Product
Beef Barbacoa on Panini Focaccia, Item 70659. Net Weight 14.85 lbs. 36 - 6.60 oz. portions. Keep Frozen. For institutional use only. Buddy's Kitchen, Inc., Burnsville, MN 55337
Category
Food
Distribution
8 states
HighFDA (Food)·F-0352-2019·2018-11-07
Trader Joe's Tomato & Basil Hummus Dip Recalled for Contamination Risk
Bakkavor Foods USA is recalling Trader Joe's Tomato & Basil Hummus Dip due to potential Salmonella and Listeria monocytogenes contamination.
Product
Trader Joe's Tomato & Basil Hummus Dip, 7 oz. plastic container; Perishable, Keep Refrigerated. SKU 29153
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0345-2019·2018-11-07
Allsup's Green Chile Burritos Recalled for Potential Contamination
Ajinomoto Windsor Inc. is recalling Allsup's Hatch Green Chile & Cheese Burritos due to potential Salmonella or Listeria contamination in diced green peppers.
Product
Allsup's Hatch Green Chile & Cheese Burrito, 72/4.5 oz burritos per case
Category
Food
Distribution
6 states
HighFDA (Food)·F-0360-2019·2018-11-07
Caito Foods Recalls Stuffed Mushrooms for Listeria and Salmonella Risk
Caito Foods LLC is recalling 64 units of Southwest Stuffed Mushrooms due to potential contamination with Listeria monocytogenes or Salmonella.
Product
MUSHROOM PRTBELA SOUTHWEST STUFFED; 8oz. Black Foam Over-wrapped Trays; Keep Refrigerated; UPC 0884853631037
Category
Food
Distribution
7 states
HighFDA (Food)·F-0353-2019·2018-11-07
Vosges Haut-Chocolat Caramels et Chocolats Recalled for Wheat Labeling Error
Vosges Haut-Chocolat is recalling Caramels et Chocolats because the outer packaging fails to declare wheat, although the inner packaging does.
Product
Caramels et Chocolats. Each retail tube contains four varieties on chocolate bonbons. Net wt per tube 3.8 oz.
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-0364-2019·2018-11-07
Baxter Recalls Exactamix Empty EVA Bags Due to Leak Risk
Baxter Healthcare is recalling 110,134 units of Exactamix Empty EVA Bags because they may leak after being used for compounding sterile solutions.
Product
EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0311-2019·2018-11-07
Philips Brilliance iCT SP CT Scanners Recalled for Misleading Calcium Score Reports
Philips is recalling 626 Brilliance iCT SP CT scanners because specific software versions generate confusing calcium score reports that may lead to patient mistreatment.
Product
Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0199-2019·2018-11-07
Pharm D Solutions Recalls Trimix Powder Due to Sterility Concerns
Pharm D Solutions is recalling 715 vials of Trimix powder nationwide due to a lack of assurance of sterility.
Product
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/10 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1365-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0117-2019·2018-11-07
Sprayology Recalls Arnica Power Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling 3,531 bottles of Arnica Power Homeopathic Oral Spray due to manufacturing deviations that could result in microbial contamination.
Product
Arnica Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0032-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0338-2019·2018-11-07
Sargento IQF Goat Cheese Recalled for Potential Listeria or Salmonella
Sargento Foods is recalling IQF Goat Cheese with Tomatoes and Kale due to potential Listeria monocytogenes or Salmonella contamination.
Product
Sargento IQF Goat Cheese with Tomatoes and Kale. Product 10001148 and 4610034611 1/28 lb., Net Wt 28.000 lbs. Keep Frozen. Manufactured by Sargento Foods, Inc., Plymouth, WI 53073
Category
Food
Distribution
3 states
HighFDA (Food)·F-0075-2019·2018-11-07
Foodstirs Organic Mug Cake Mix Recalled for Undeclared Milk Allergen
Foodstirs is recalling Organic Minute Mug Cake Mix Celebration Confetti 4-packs because individual pouches fail to declare milk as an allergen.
Product
Foodstirs Modern Baking; Organic Minute Mug Cake Mix Celebration Confetti - 4 - 2.54 oz. (72g) Pouches per carton -Carton Net Wt. 10.16 oz. (288g) Carton UPC; 816524 02789 Master case UPC: 816524 020796
Category
Food
Distribution
11 states
HighFDA (Devices)·Z-0306-2019·2018-11-07
Philips IQon Spectral CT Software Recall for Misleading Calcium Score Reports
Philips is recalling IQon Spectral CT scanners with specific software versions because the Calcium Score report provides confusing and potentially misleading plaque analysis data.
Product
IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0295-2019·2018-11-07
Arthrex Recalls Li-ion Battery Housings for AR-400 DrillSaw Sports 400 System
Arthrex, Inc. is recalling 335 Li-ion Battery Housings for the AR-400 DrillSaw Sports 400 System because they may not provide a complete seal, allowing for potential fluid ingress.
Product
Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0430-2019·2018-11-07
Portland Chocolate Recalls 60% Dark Chocolate Chips Due to Peanut Cross-Contamination
Portland Chocolate Company LLC is recalling 60% Dark Chocolate Chips due to cross-contamination with peanut. The product was distributed in Oregon and California.
Product
60% Dark Chocolate Chips, packaged in poly-lined cardboard boxes, net wt. 30 lbs. The label is read in parts: "*** Pitch Dark Chocolate*** 60% Dark Chocolate ***Bulk 30lbs *** Produced in a facility that also processes: Peanuts, tree nuts, dairy ***".
Category
Food
Distribution
2 states
HighFDA (Food)·F-0331-2019·2018-11-07
Buddy's Kitchen Mushroom & Thyme Flatbread Pizza Recalled for Contamination Risk
Buddy's Kitchen is recalling Mushroom & Thyme Flatbread Pizza due to potential Listeria or Salmonella contamination linked to a McCain Foods recall.
Product
Mushroom & Thyme Flatbread Pizza, Item 70610. Net Weight 7.65 lbs. 48-2.55 oz. portions. Keep Frozen. For institutional use only. Buddy's Kitchen, Inc., Burnsville, MN 55337
Category
Food
Distribution
8 states
HighFDA (Drugs)·D-0122-2019·2018-11-07
Sprayology Recalls ImmunoBooster Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling 2,837 bottles of ImmunoBooster Homeopathic Oral Spray nationwide due to manufacturing conditions that could result in microbial contamination.
Product
ImmunoBooster, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0038-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0332-2019·2018-11-07
Buddy's Kitchen Recalls Huevos Rancheros Benedict Due to Listeria Risk
Buddy's Kitchen is recalling Huevos Rancheros Style Benedict products due to potential Listeria or Salmonella contamination linked to a McCain Foods recall.
Product
Huevos Rancheros Style Benedict with Seasoned Black Beans, Item 70614. Net Weight 9.60 lbs. 24-6.40 oz. portions. Keep Frozen. For institutional use only. Buddy's Kitchen, Inc., Burnsville, MN 55337
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-0367-2019·2018-11-07
Baxter Recalls EXACTAMIX Empty EVA Bags Due to Potential Leaking
Baxter Healthcare is recalling 281,350 units of EXACTAMIX Empty EVA Bags because they may leak after being used for compounding.
Product
EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0366-2019·2018-11-07
Baxter Recalls Exactamix Empty EVA Bags Due to Leak Risk
Baxter Healthcare is recalling 456,071 units of Exactamix Empty EVA Bags because they may leak after being used for compounding sterile solutions.
Product
EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0344-2019·2018-11-07
Posada Hatch Green Chile & Cheese Burrito Recalled for Potential Contamination
Ajinomoto Windsor Inc. is recalling Posada Hatch Green Chile & Cheese Burritos due to potential Salmonella or Listeria contamination from diced green peppers.
Product
Posada Hatch Green Chile & Cheese Burrito, 72/4.5 oz burritos per case
Category
Food
Distribution
6 states
HighFDA (Drugs)·D-0121-2019·2018-11-07
Sprayology Recalls Life Detoxer Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling 1,473 bottles of Life Detoxer Homeopathic Oral Spray because manufacturing conditions could result in possible microbial contamination.
Product
Life Detoxer Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879NDC 61096-0023-1 and Tester NDC 61096-1023-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0335-2019·2018-11-07
Buddy's Kitchen Recalls Frozen Stir Fry Wraps Due to Contamination Risk
Buddy's Kitchen is recalling frozen Stir Fry Wrap with Rice, Broccoli & Peppers due to potential Listeria or Salmonella contamination linked to a McCain Foods recall.
Product
Stir Fry Wrap with Rice, Broccoli & Peppers, Item 70668. Net Weight 17.50 lbs. 56 - 5.00 oz. portions. Keep Frozen. For institutional use only. Buddy's Kitchen, Inc., Burnsville, MN 55337
Category
Food
Distribution
8 states
HighFDA (Food)·F-0076-2019·2018-11-07
Gourmet Specialties Recalls Fresh Basil for Potential Cyclospora Contamination
Gourmet Specialties Inc. is recalling fresh basil from Mexico due to potential Cyclospora cayetanensis contamination. The product was distributed in California, Illinois, Nevada, and Arizona.
Product
Fresh Herb Basil 62/4oz., LB 2489, 135/5Bulk, 24/8oz., 12/10 bulk Product of Mexico
Category
Food
Distribution
4 states
HighFDA (Food)·F-0336-2019·2018-11-07
Buddy's Kitchen Recalls Philly Steak Sandwiches Due to Listeria or Salmonella Risk
Buddy's Kitchen is recalling Philly Steak Sandwiches due to potential Listeria or Salmonella contamination, linked to a McCain Foods recall.
Product
Philly Steak Sandwich, Item 06433. Net Weight 17.50 lbs. 56 - 5.00 oz. portions. Keep Frozen. For institutional use only. Buddy's Kitchen, Inc., Burnsville, MN 55337
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-0363-2019·2018-11-07
Baxter Recalls Exactamix Empty EVA Bags Due to Leak Risk
Baxter Healthcare is recalling 158,163 units of Exactamix Empty EVA Bags because they may leak after being used for compounding.
Product
EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0356-2019·2018-11-07
Caito Foods Recalls Southwest Sweet Potato Rice Due to Contamination Risk
Caito Foods LLC is recalling 920 units of Southwest Sweet Potato Rice due to potential contamination with Listeria monocytogenes or Salmonella.
Product
SOUTHWEST SWEET POTATO RICE; 12oz. Plastic Clamshell; Keep Refrigerated; UPC 0826766185610
Category
Food
Distribution
7 states
HighFDA (Food)·F-0355-2019·2018-11-07
Caito Foods Recalls Southwest Stuffed Portabella Mushrooms Due to Contamination Risk
Caito Foods LLC is recalling 220 units of Southwest Stuffed Portabella Mushrooms due to potential contamination with Listeria monocytogenes or Salmonella.
Product
SOUTHWEST STUFFED PORTABELLA MUSHROOM; 8oz. Black Foam Over-wrapped Trays; Keep Refrigerated; UPC 0081851202676
Category
Food
Distribution
7 states
HighFDA (Devices)·Z-0305-2019·2018-11-07
Philips Brilliance iCT Scanners Recalled for Misleading Calcium Score Reports
Philips is recalling Brilliance iCT scanners because software errors create confusing calcium score reports that may lead to patient mistreatment.
Product
Brilliance iCT (Model No. 728306), Software Version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may incl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0301-2019·2018-11-07
Roche Diagnostics Recalls URISYS 1100 Urine Analyzers Due to Detection Limits
Roche Diagnostics is recalling 14,398 URISYS 1100 Urine Analyzers because limits of detection for certain parameters were higher than listed, potentially causing false negative results.
Product
Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a reflectance photometer designed to automatically read and evaluate the results of Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA urine
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0077-2019·2018-11-07
Forager Project Organic Protein Plant Shake Recalled for Undeclared Almonds
Forager Project LLC is recalling 2,256 cases of Organic Protein Plant Shake due to undeclared tree nuts (almonds).
Product
Forager Project Organic Protein Plant Shake Nuts & Vanilla 12 fl oz. UPC: 8 14558 02038 6
Category
Food
Distribution
13 states
HighNHTSA·18E101000·2018-11-07
Kidde Fire Extinguishers Recalled for Potential Actuator Failure in Buses
Kidde is recalling specific fire extinguishers used in bus fire suppression systems because the actuator may fail to discharge the agent, increasing injury risk during a fire.
Product
EQUIPMENT recall
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0313-2019·2018-11-07
BD Max Instrument Recall for False Positive Candida Results
Becton Dickinson is recalling 49 refurbished BD Max instruments due to a confirmed trend of false positive Candida glabrata results when Trichomonas vaginalis is present.
Product
BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0106-2019·2018-11-07
Sprayology Recalls Man Power Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling Man Power Homeopathic Oral Spray because it was manufactured under conditions that could result in possible microbial contamination.
Product
Man Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0025-1 and Tester NDC 61096-1025-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0309-2019·2018-11-07
Philips CT Scanner Software Recall for Misleading Calcium Score Reports
Philips is recalling Ingenuity Core CT scanners with software version 4.1.6 because the Calcium Score report may display confusing plaque analyses, potentially leading to patient mistreatment.
Product
Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may incl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0307-2019·2018-11-07
Philips CT Scanner Software Recall for Misleading Calcium Score Reports
Philips is recalling 145 CT scanners with software version 4.2.0 because the Calcium Score report may display confusing plaque analyses, potentially leading to patient mistreatment.
Product
Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0303-2019·2018-11-07
Philips CT Scanner Software Recall for Misleading Calcium Score Reports
Philips is recalling 145 CT scanners because software version 4.2.0 generates confusing calcium score reports that may lead to patient mistreatment.
Product
Brilliance Big Bore Oncology CT (Model No. 728243) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0302-2019·2018-11-07
Philips Recalls Vereos PET/CT Software Due to Image Errors
Philips Medical Systems is recalling 61 units of Vereos PET/CT software version 2.0.1 due to errors that may produce incorrect images or disrupt procedures.
Product
Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0285-2019·2018-11-07
Magellan LeadCare II Blood Lead Test Kit Recalled for Calibration Defect
Magellan Diagnostics is recalling LeadCare II Blood Lead Test Kits because a calibration defect causes all patient results to display as HIGH.
Product
Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is for in vitro diagnostic use only. The test kit is for the quantitative me
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0357-2019·2018-11-07
Caito Foods Recalls Ancho Chili Cauliflower Rice for Pathogen Risk
Caito Foods LLC is recalling 605 units of Ancho Chili & Corn Cauliflower Rice due to potential contamination with Listeria monocytogenes or Salmonella.
Product
ANCHO CHILI & CORN CAULIFLOWER RICE; 12oz. Plastic Clamshell; Keep Refrigerated; UPC 0826766185900
Category
Food
Distribution
7 states
HighFDA (Drugs)·D-0190-2019·2018-11-07
Pharm D Solutions Recalls Tri-Mix XL Injectable Due to Sterility Concerns
Pharm D Solutions is recalling 553 vials of Tri-Mix XL injectable and powder nationwide due to a lack of assurance of sterility.
Product
Tri-Mix XL 150 mg/10 mg/100 mcg a) Injectable NDC 69699-1353-10; b) (LYO) Powder NDC 69699-1353-10, Pharm D Solutions, Houston, Texas
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0365-2019·2018-11-07
Baxter Recalls Exactamix Empty EVA Bags Due to Leak Risk
Baxter Healthcare is recalling 136,800 units of Exactamix Empty EVA Bags because they may leak after being used for compounding sterile solutions.
Product
EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0304-2019·2018-11-07
Philips Brilliance 64 CT Scanner Software Recall for Misleading Reports
Philips is recalling Brilliance 64 CT scanners with software version 4.1.6 because the Calcium Score report may display confusing information, potentially leading to patient mistreatment.
Product
Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may inclu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0112-2019·2018-11-07
Sprayology Recalls Cold + Flu Relief Homeopathic Oral Spray
Sprayology is recalling Cold + Flu Relief Homeopathic Oral Spray due to CGMP deviations that could result in microbial contamination.
Product
Cold + Flu Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0002-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0074-2019·2018-11-07
Lone Star Bakery Recalls Veggie Pie Due to Foreign Object Risk
Lone Star Bakery is recalling Veggie Pie products because they may contain a foreign object. The recall affects specific lots distributed in five states.
Product
Veggie Pie packaged in a paper carton, Net Wt 6 OZ, Keep Frozen
Category
Food
Distribution
5 states
HighFDA (Food)·F-0359-2019·2018-11-07
Caito Foods Recalls Street Corn for Listeria and Salmonella Contamination
Caito Foods LLC is recalling 115 units of Street Corn due to potential contamination with Listeria monocytogenes or Salmonella. The product was distributed in seven states.
Product
STREET CORN; 6oz. Plastic Clamshell; Keep Refrigerated; UPC 0884853641067
Category
Food
Distribution
7 states
HighFDA (Food)·F-0351-2019·2018-11-07
Trader Joe's Hummus Recalled for Potential Salmonella and Listeria Contamination
Bakkavor Foods USA is recalling Trader Joe's Hummus quartets due to potential Salmonella and Listeria monocytogenes contamination. Consumers should discard the product.
Product
Trader Joe's Hummus quartet; 20 oz. plastic container; Spicy Hummus Roasted Garlic Hummus, Regular Hummus and Tomato Basil Hummus. Perishable, Keep Refrigerated. SKU 39570
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0358-2019·2018-11-07
Caito Foods Recalls Stuffed Crimini Mushrooms Due to Pathogen Contamination Risk
Caito Foods LLC is recalling 204 units of 7-ounce stuffed crimini mushrooms due to potential contamination with Listeria monocytogenes or Salmonella.
Product
MUSHROOM CRIMINI SOUTHWEST STUFFED; 7oz. Black Foam Over-wrapped Trays; Keep Refrigerated; UPC 0884853631044
Category
Food
Distribution
7 states
HighFDA (Drugs)·D-0165-2019·2018-11-07
Pharm D Solutions Recalls Levocarnitine Injectable Due to Sterility Concerns
Pharm D Solutions is recalling Levocarnitine 170 mg/mL Injectable because the product lacks assurance of sterility. The recall covers 3,000 milliliters distributed nationwide.
Product
Levocarnitine 170 mg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1617-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0330-2019·2018-11-07
Kwik Trip Recalls 4 Cheese Margherita Pizza Due to Listeria Risk
Kwik Trip is recalling 4 Cheese Margherita Pizza due to potential contamination with Listeria or Salmonella. The recall affects 57,981 units distributed in Iowa, Minnesota, and Wisconsin.
Product
Kitchen Cravings Wood Fired Crust 4 Cheese Margherita Pizza, Net Wt. 28.39 oz (1 lb. 12.3 oz.) 804g. UPC 39779-00073. Produced & Distributed by Kwik Trip Inc., Lacrosse WI 54603
Category
Food
Distribution
3 states
HighFDA (Food)·F-0337-2019·2018-11-07
Sargento IQF Veggie Burgers Recalled for Potential Listeria and Salmonella
Sargento Foods is recalling specific IQF Veggie Burgers due to potential Listeria monocytogenes or Salmonella contamination. The affected products were distributed in Florida, Ohio, and Wisconsin.
Product
Sargento IQF Veggie Burger. Product 10001725 6/4 lb., and Product 4610035085 6/4lb. Keep Frozen. Manufactured by Sargento Foods, Inc., Plymouth, WI 53073
Category
Food
Distribution
3 states
HighFDA (Drugs)·D-0113-2019·2018-11-07
Sprayology Recalls DigestivEase Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling 1,465 bottles of DigestivEase Homeopathic Oral Spray due to manufacturing conditions that could result in microbial contamination.
Product
DigestivEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0005-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0340-2019·2018-11-07
Karlsburger Kitchens Roasted Onion Base Recalled for Listeria and Salmonella Risk
Karlsburger Foods is recalling Roasted Onion Base due to potential Listeria monocytogenes and Salmonella contamination.
Product
Karlsburger Kitchens Roasted Onion Base, item # 23650, Net Weight 50 lbs (22.68 kg), UPC 60492-23650. Karlsburger Foods, Inc., Monticello, MN 55362
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-0315-2019·2018-11-07
Cook Medical Recalls Zilver 518 Biliary Stent Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 518 Biliary Stent 4mm x 30mm, Catalog Number: ZIB5-125-4.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0120-2019·2018-11-07
Sprayology Recalls PMS Support Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling 647 bottles of PMS Support Homeopathic Oral Spray due to manufacturing conditions that could result in possible microbial contamination.
Product
PMS Support, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0031-1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0339-2019·2018-11-07
Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-80-12.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0314-2019·2018-11-07
Cook Medical Recalls Zilver 518 Biliary Stents Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 518 Biliary Stent 4mm x 20mm, Catalog Number: ZIB5-125-4.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0110-2019·2018-11-07
Sprayology Recalls Bone Builder Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling Bone Builder Homeopathic Oral Spray because it was manufactured under conditions that could result in possible microbial contamination.
Product
Bone Builder, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0012-1 and Tester NDC 61096-1012-1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0336-2019·2018-11-07
Cook Medical Recalls Zilver 635 Biliary Stent for Incorrect Instructions
Cook Medical is recalling Zilver 635 Biliary Stents because the instructions for use contain incorrect details regarding the removal of the delivery system.
Product
Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0108-2019·2018-11-07
Sprayology Recalls Woman Power Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling 1,284 bottles of Woman Power Homeopathic Oral Spray due to manufacturing conditions that could result in microbial contamination.
Product
Woman Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879 NDC 61096-0034-1 and Tester NDC 61096-1034-1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0341-2019·2018-11-07
Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-80-14.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0116-2019·2018-11-07
Sprayology Recalls Party Relief Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling 2,956 bottles of Party Relief Homeopathic Oral Spray due to manufacturing conditions that could result in possible microbial contamination.
Product
Party Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0030-1 and Tester NDC 61096-1030-1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0317-2019·2018-11-07
Cook Medical Recalls Zilver 518 Biliary Stents Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 518 Biliary Stent 4mm x 60mm, Catalog Number: ZIB5-125-4.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0335-2019·2018-11-07
Cook Medical Recalls Zilver 635 Biliary Stent Due to Instruction Error
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-125-5.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0356-2019·2018-11-07
Beckman Coulter iPAW 4.2 Software Recalled for Barcode Labeling Errors
Beckman Coulter is recalling the iPAW 4.2 User Kit software because a specific manual barcode printing function may generate incorrect IDs for sample tubes.
Product
Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckman Coulter Biomedical GmbH The iPAW 4.2 User Kit (PN B73489) includes the iPAW software application CD (version 4.2). This function is primarily used to copy an existing barcode ID to replace the labe
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0109-2019·2018-11-07
Sprayology Recalls MenoPower Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling MenoPower Homeopathic Oral Spray because it was manufactured under conditions that could result in possible microbial contamination.
Product
MenoPower, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0014-1 and Tester NDC 61096-1014
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0115-2019·2018-11-07
Sprayology Recalls TravelEase Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling 1,307 bottles of TravelEase Homeopathic Oral Spray nationwide due to manufacturing deviations that could result in microbial contamination.
Product
TravelEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879NDC 61096-0007-1. and Tester NDC 61096-1007-1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0324-2019·2018-11-07
Cook Medical Recalls Zilver 635 Biliary Stents Due to Incorrect Instructions
Cook Medical is recalling Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-125-12.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0293-2019·2018-11-07
CMP Industries Recalls Dental Acrylic Resin Due to Foreign Material
CMP Industries is recalling 40 units of Technoflux IMPAK dental acrylic resin because foreign material was found in the product.
Product
Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1 REF: 3748GB. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0372-2019·2018-11-07
Siemens EVO Excel CT System Recalled for Mis-Labeled Current Limit
Siemens Medical Solutions is recalling 264 EVO Excel CT systems because the external ECG power-connection current limit is mis-labeled as 1.0A instead of 0.55A.
Product
EVO Excel, Emission Computed Tomographic System, Material Number 10910501
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0357-2019·2018-11-07
Beckman Coulter iPAW Software Recall for Barcode Label Errors
Beckman Coulter is recalling iPAW 4.2.1 software due to a defect that may generate incorrect barcode IDs when printing consecutive tube labels.
Product
Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95343, Manufactured by: Beckman Coulter Biomedical GmbH Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for m
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0347-2019·2018-11-07
Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-80-5.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0346-2019·2018-11-07
Faribault Foods Recalls S & W White Beans for Undeclared Sulfites
Faribault Foods is recalling 2,700 cans of S & W White Beans sold in Oregon and Washington due to undeclared sulfites.
Product
S & W White Beans, Net Wt 15 oz (425g), UPC 72273-38807. Distributed by Faribault Foods, 1818 2nd Ave NW, Faribault, MN 55021-3035.
Category
Food
Distribution
2 states
ModerateFDA (Devices)·Z-0328-2019·2018-11-07
Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-125-14.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0338-2019·2018-11-07
Cook Medical Recalls Zilver 635 Biliary Stents Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-80-12.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0282-2019·2018-11-07
Arrow Multi-Lumen CVC Kit Recalled for Expired Product Documentation Error
Arrow International Inc. is recalling 105 units of Arrow AGB + Multi-Lumen CVC Kits because shipping documentation listed an incorrect expiration date, though the product lidstock is correct.
Product
Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: Lack of
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0320-2019·2018-11-07
Cook Medical Recalls Zilver 518 Biliary Stent Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 518 Biliary Stent 5mm x 30mm, Catalog Number: ZIB5-125-5.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0344-2019·2018-11-07
Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instructions for use contain incorrect details regarding the removal of the delivery system.
Product
Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-80-14.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0346-2019·2018-11-07
Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-80-5.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0105-2019·2018-11-07
Sprayology Recalls Rejuvenation Plus Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling 1,558 bottles of Rejuvenation Plus Homeopathic Oral Spray due to manufacturing conditions that could result in possible microbial contamination.
Product
Rejuvenation Plus, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879 NDC 61096-0035-1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0126-2019·2018-11-07
Sprayology Recalls Diet Power Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling Diet Power Homeopathic Oral Spray because it was manufactured under conditions that could result in possible microbial contamination.
Product
Diet Power, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0004-1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0296-2019·2018-11-07
BioFire FilmArray Blood Culture Identification Test Recall for False Positives
BioFire Diagnostics is recalling FilmArray Blood Culture Identification tests due to an increased risk of false positive results for Proteus when used with specific blood culture bottles.
Product
FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test kit)/ 00815381020086, RFIT-ASY-0127 (6 test kit)/ 00815381020093, when used with the following blood culture bottles: Bottle Description
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0345-2019·2018-11-07
Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-80-4.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0362-2019·2018-11-07
Fresenius Kabi Recalls Volumat MC Agilia Infusion Pumps for Software Upgrade
Fresenius Kabi is recalling 7,082 Volumat MC Agilia Volumetric Infusion Pumps to install a mandatory software upgrade that prevents common software malfunctions.
Product
Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospi
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0348-2019·2018-11-07
Cook Medical Recalls Zilver 635 Biliary Stent for Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-80-5.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0149-2019·2018-11-07
Pharm D Solutions Recalls Calcium Gluconate Due to Sterility Concerns
Pharm D Solutions is recalling specific lots of Calcium Gluconate 2.5% products due to a lack of assurance of sterility.
Product
Calcium Gluconate 2.5% a) 250 mL 25 mg/mL NDC 69699-0908-25; b) Nasal Spray 2.5 Inhal Soln. NDC 69699-0908-10; c) Nebulization Solution 2.5% Inhal. Soln NDC 69699-0908-10; d) Nebulization 250 mL 2.5% Inhal Soln NDC 69699-0908-25; e) Oral Spray 2.5% 2.5% Oral Soln NDC 69699-0917-6
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0128-2019·2018-11-07
Boehringer Ingelheim Recalls Catapres Tablets Due to Dissolution Failures
Boehringer Ingelheim is recalling specific bottles of Catapres tablets because routine stability testing revealed they failed to meet dissolution specifications.
Product
Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. Made in Germany. NDC 0597-0007-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0326-2019·2018-11-07
Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-125-12.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0125-2019·2018-11-07
Sprayology Recalls Body Balance Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling Body Balance Homeopathic Oral Spray because it was manufactured under conditions that could result in possible microbial contamination.
Product
Body Balance, Homeopathic Oral Spray 1.38 fl. oz (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0039-1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0119-2019·2018-11-07
Sprayology Recalls Stress Relief Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling 3,896 bottles of Stress Relief Homeopathic Oral Spray because it was manufactured under conditions that could result in possible microbial contamination.
Product
Stress Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0006-1 and Tester NDC 61096-1006-1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0319-2019·2018-11-07
Cook Medical Recalls Zilver 518 Biliary Stent Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 518 Biliary Stent 5mm x 20mm, Catalog Number: ZIB5-125-5.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0343-2019·2018-11-07
Wegmans Recalls Hummus Due to Potential Plastic Foreign Material
Wegmans is recalling specific lots of hummus because they may contain plastic. Consumers should check their pantry and stop eating the product.
Product
Wegmans Hummus, NET WT 32 OZ (2 LB) 908g, UPC: 77890-26221 and NET WT 8 OZ (227g), UPC: 77890-26213
Category
Food
Distribution
6 states
ModerateFDA (Devices)·Z-0294-2019·2018-11-07
RayStation Software Recalled for Unsupported Robust Optimization Feature
RaySearch Laboratories AB is recalling RayStation software versions 4.5 through 7 because robust optimization for specific plans is not supported.
Product
RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0353-2019·2018-11-07
Beckman Coulter Recalls iPAW Software Due to Barcode Labeling Errors
Beckman Coulter is recalling iPAW software versions 4.2 and 4.2.1 because a specific barcode printing feature may generate incorrect IDs for tube labels.
Product
Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software v4.2.1), Beckman Coulter, Inc. The iPAW ((intelligent Peri-Analytical Workstation) can act as: a software client for specimen tracking and workload statistics or a physical workstation for manua
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0114-2019·2018-11-07
Sprayology Recalls SleepEase Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling 5,393 bottles of SleepEase Homeopathic Oral Spray nationwide due to manufacturing deviations that could result in possible microbial contamination.
Product
SleepEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0001-1 and Tester NDC 6196-1001-1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0287-2019·2018-11-07
Zimmer Biomet Recalls SpF PLUS-Mini Spinal Fusion Stimulators for Cleanliness Issues
Zimmer Biomet is recalling SpF PLUS-Mini implantable spinal fusion stimulators because the company lacked adequate validation to ensure product cleanliness parameters were consistently met.
Product
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0361-2019·2018-11-07
Equal Exchange Recalls Organic Breakfast Blend Decaf Coffee Due to Caffeine Mislabeling
Equal Exchange is recalling Organic Mind Body and Soul Breakfast Blend Decaf coffee because caffeinated coffee was packaged in decaffeinated packaging.
Product
Organic Mind Body and Soul - Breakfast Blend Decaf, packaged in 2.25 oz. pillow packs.
Category
Food
Distribution
13 states
ModerateFDA (Devices)·Z-0340-2019·2018-11-07
Cook Medical Recalls Zilver 635 Biliary Stent Due to Instruction Error
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-80-12.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide

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