The Recall Desk

Archive

April 2017 recalls

850 recalls were announced in April 2017.

What the numbers show

Critical
99
Severe
150
High
458
Moderate
121
Low
22

Of the 850 recalls this month scored against our rubric, 12% are Critical, 18% are Severe.

601–700 of 850

  • CriticalFDA (Food)·F-1721-2017·2017-04-05

    FDA Recalls Ruth's Lite Pimento Spread Due to Listeria Risk

    B & H Foods is recalling 2,776 units of Ruth's Lite Pimento Spread because the product may be contaminated with Listeria monocytogenes.

    Product
    Ruth's Lite Pimento Spread, 12 oz. (UPC 74952-12000), Packed By: B & H Foods, 181 Saluda ST, Chester, SC 29706, packed in plastic containers.
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1799-2017·2017-04-05

    Lipari Old Tyme Colby Jack Cheese Recalled for Listeria Risk

    Lipari Foods is recalling Old Tyme Colby Jack Cheese due to potential Listeria monocytogenes contamination from a supplier.

    Product
    Lipari Old Tyme Colby Jack Cheese, 12/8 oz.
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Food)·F-1754-2017·2017-04-05

    Cumberland Valley Creamery Recalls Unlabeled Chevre for E. coli

    Cumberland Valley Creamery is recalling unlabeled Chevre cheese in Maryland and Pennsylvania because laboratory tests found E. coli levels exceeding allowed limits.

    Product
    Chevre unlabeled, Manufactured for repacking and relabeling.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1767-2017·2017-04-05

    Cumberland Valley Creamery Recalls Colby Tomato Basil Cheese for E. coli

    Cumberland Valley Creamery is recalling Luqman and Dutchland Homestead Colby Tomato Basil cheese because laboratory analysis found E. coli levels exceeding allowed limits.

    Product
    Luqman Cheese, Colby Tomato Basil, Net Wt. 8 oz.., Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA Dutchland Homestead, Colby Cheese Tomato Basil, Net Weight 8 oz., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1575-2017·2017-04-05

    FDA Recalls 170 Sterile Laparoscopic Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 170 sterile laparoscopic procedure trays because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 880341003, Sterile, GS0775C - Laparoscopic - OSU
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Food)·F-1803-2017·2017-04-05

    Lipari Old Tyme Muenster Cheese Recalled for Listeria Risk

    Lipari Foods is recalling Old Tyme Muenster Cheese due to potential Listeria monocytogenes contamination from a supplier.

    Product
    Lipari Old Tyme Muenster Cheese, 12/8 oz.
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Food)·F-1816-2017·2017-04-05

    Baidyanath Brahmi Bati Recalled for Heavy Metal Contamination

    Butala Emporium is recalling Baidyanath brand Brahmi Bati dietary supplements because they contain lead, mercury, and/or arsenic at levels exceeding permissible limits.

    Product
    Baidyanath brand Brahmi Bati, Dietary Supplement, 80 Tablets -- Product of India --- Mfd in India - Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane, Kolkata 700006
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-1719-2017·2017-04-05

    B & H Foods Recalls Pimento Spread for Listeria Risk

    B & H Foods is recalling Ruth's Old Fashion Pimento Spread due to potential Listeria monocytogenes contamination. The product was distributed in six southeastern states.

    Product
    Ruth's Old Fashion Pimento Spread, 16oz. (UPC 74952-15005), Packed By: B & H Foods, 181 Saluda ST, Chester, SC 29706, packed in plastic containers.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1699-2017·2017-04-05

    Stryker Visum LED Surgical Lighting System Recalled for Mounting Defect

    Stryker is recalling 292 Visum LED Surgical Lighting systems because missing screws and user overloading may cause the equipment to fall.

    Product
    The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Affected part numbers are 0682001432 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/FP), 0682001286 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1804-2017·2017-04-05

    Freshbev Apple Juice Recalled for Elevated Patulin Levels

    Freshbev LLC is recalling 5-gallon apple juice and 2-oz immunity shots due to elevated patulin levels. The products were distributed in five states.

    Product
    Apple Juice 5 Gal, Keep Refrigerated, Ripe Liquid Produce
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1788-2017·2017-04-05

    Cookies Nezhakomka Recalled for Undeclared Milk Allergen

    Kusher LLC is recalling Cookies Nezhakomka because the label fails to declare milk, a major allergen, despite the product containing butter.

    Product
    COOKIES NEZHAKOMKA, product is packaged in plastic clamshells container, Net Weight: 454g (16 OZ), UPC: 8 51929 00366 1. The label is read in parts: "***COOKIES "NEZNAKOMKA" *** INGREDIENTS: WHEAT FLOUR (FLOUR, NIACIN, IRON, THIAMINE MONONITRATE, RIBOFLAVIN, FOLIC ACID) ASCO
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1774-2017·2017-04-05

    Meijer Recalls Ham and Cheddar Sandwiches for Listeria Risk

    Meijer Distribution is recalling specific Ham & Cheddar on White Baguette Sandwiches due to potential Listeria monocytogenes contamination.

    Product
    Ham & Cheddar on White Baguette Sandwich 9.2oz retail Plastic packaging Ready to Eat sandwich Keep Refrigerated
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1561-2017·2017-04-05

    FDA Recalls Sterile Custom Procedure Trays Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 42 sterile custom procedure trays because a light glove component can split, potentially breaking the sterile field.

    Product
    Regard, Item Number: 880323003, Sterile, LD0754C - C Section - OSU
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Food)·F-1812-2017·2017-04-05

    Baidyanath Shankh Bati Dietary Supplement Recalled for Heavy Metals

    Butala Emporium, Inc. is recalling Baidyanath brand Shankh Bati dietary supplements found to contain lead, mercury, and/or arsenic at levels exceeding permissible limits.

    Product
    Baidyanath brand Shankh Bati, Dietary Supplement, 80 Tablets -- Product of India --- Mfd in India - Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane, Kolkata 700006
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-1739-2017·2017-04-05

    Oriental Jamaican Hot Curry Powder Recalled for Lead Contamination

    Oriental Packing Co. is recalling 50 lb bulk bags of Oriental Jamaican Hot Curry Powder because the product contains lead.

    Product
    Oriental Jamaican Hot Curry Powder, 50 lb bulk. Manufactured by Oriental Packing Co.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1757-2017·2017-04-05

    Cumberland Valley Creamery Recalls Garlic Cheese Curds Due to E. coli

    Cumberland Valley Creamery is recalling unlabeled Garlic Cheese Curds because laboratory analysis found levels of E. coli exceeding allowed limits.

    Product
    Garlic Cheese Curds, unlabeled, Manufactured for repack and relabel cheeses.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1759-2017·2017-04-05

    Cumberland Valley Creamery Recalls Unlabeled Cheeses for E. coli

    Cumberland Valley Creamery is recalling 17,241 lbs of unlabeled cheeses in Maryland and Pennsylvania because laboratory tests found E. coli levels exceeding allowed limits.

    Product
    Mineiro, unlabeled, Manufactured for repack and relabel cheeses.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0618-2017·2017-04-05

    Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

    Mylan Pharmaceuticals is recalling specific lots of Atorvastatin Calcium 10 mg tablets due to potential microbial contamination and elevated bioburden.

    Product
    Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09); c) 500-count bottles (NDC 0378-3950-05); d) 500-count bottles (NDC 0378-3950-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1722-2017·2017-04-05

    B & H Foods Recalls Ruth's Cream Cheese for Listeria Risk

    B & H Foods is recalling 459 units of Ruth's Cream Cheese w/Pineapple-Pecans due to potential Listeria monocytogenes contamination. The product was distributed in six southeastern states.

    Product
    Ruth's Cream Cheese w/Pineapple-Pecans, 12 oz. (UPC 74952-12008), Packed By: B & H Foods, 181 Saluda ST, Chester, SC 29706, packed in plastic containers.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-1773-2017·2017-04-05

    Meijer Muenster Cheese Recalled for Potential Listeria Contamination

    Meijer Distribution is recalling 8oz packages of Artisan Made Natural Muenster Cheese due to potential Listeria monocytogenes contamination.

    Product
    Meijer Artisan Made Natural Muenster Cheese 8oz retail Plastic packaging Keep Refrigerated
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-1775-2017·2017-04-05

    Meijer Colby and Colby Jack Deli Cheese Recalled for Listeria Risk

    Meijer Distribution is recalling Colby and Colby Jack deli cheese due to potential Listeria monocytogenes contamination. The product was sold by weight in six states.

    Product
    Meijer Colby and Colby Jack Deli Cheese 6lb horn; sold from the Meijer store Deli counter, by weight Sold in plastic deli packaging with printed labels
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0616-2017·2017-04-05

    Claris Recalls Metronidazole Injection Due to Sterility Concerns

    Claris Lifesciences Inc. is recalling 72,072 units of Metronidazole Injection, USP, 500 mg/100 mL, due to a potential leak that may compromise sterility.

    Product
    Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-001-24
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1646-2017·2017-04-05

    FDA Recalls Sterile Custom Procedure Trays Due to Glove Splitting Hazard

    Resource Optimization & Innovation LLC is recalling 274 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0621-2017·2017-04-05

    Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

    Mylan Pharmaceuticals is recalling Atorvastatin Calcium Tablets, 80 mg, due to potential microbial contamination and elevated bioburden.

    Product
    Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0622-2017·2017-04-05

    Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

    Mylan Institutional, Inc. is recalling 1,527 cartons of Atorvastatin Calcium 10 mg tablets due to potential microbial contamination and elevated bioburden.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0615-2017·2017-04-05

    Claris Lifesciences Recalls Levofloxacin Injection Due to Sterility Concerns

    Claris Lifesciences Inc. is recalling Levofloxacin Injection due to a potential leak that may compromise sterility. The recall covers 24,456 units distributed nationwide.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1580-2017·2017-04-05

    Recall of Regard Open Heart Procedure Kits Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 117 sterile open heart procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Food)·F-1785-2017·2017-04-05

    Kusher LLC Recalls Princesa Cookies Due to Undeclared Milk Allergen

    Kusher LLC is recalling Princesa cookies because the label fails to declare milk, a major allergen, despite the product containing butter.

    Product
    COOKIES "PRINCESA", product is packaged in plastic clamshells container, Net Weight: 454g (16 OZ). UPC: 8 51929 00359 3 The label is read in parts: "***COOKIES "PRINCESA" *** INGREDIENTS: WHEAT FLOUR (WHEAT FLOUR, NIACIN, REDUCE IRON, THIAMINE MONONITRATE, RIBOFLAVIN, FOLI
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1668-2017·2017-04-05

    Resource Optimization Recalls Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 24 sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 800508003, Sterile, LD0586C - C Section - Jasper
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Food)·F-1814-2017·2017-04-05

    Baidyanath Agnitundi Bati Recalled for Heavy Metal Contamination

    Butala Emporium, Inc. is recalling Baidyanath brand Agnitundi Bati dietary supplements because they contain lead, mercury, and/or arsenic at levels exceeding permissible limits.

    Product
    Baidyanath brand Agnitundi Bati, Dietary Supplement, 80 Tablets -- Product of India --- Mfd in India - Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane, Kolkata 700006
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-1749-2017·2017-04-05

    Cumberland Valley Creamery Recalls Harvarti Cheese for E. coli Contamination

    Cumberland Valley Creamery is recalling Luqman Cheese and Dutchland Homestead Harvarti cheeses because laboratory analysis found E. coli levels exceeding allowed limits.

    Product
    Luqman Cheese Harvarti, Net Wt. 8 oz., Distributed by Cumberland Valley Creamery; Mechanicsburg, PA; OR Dutchland Homestead Harvarti, Net Weight 8 oz., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1815-2017·2017-04-05

    Baidyanath Arogyavardhini Bati Recalled for Heavy Metal Contamination

    Butala Emporium is recalling Baidyanath Arogyavardhini Bati dietary supplements because they contain lead, mercury, and/or arsenic at levels exceeding permissible limits.

    Product
    Baidyanath brand Arogyavardhini Bati, Dietary Supplement, 80 Tablets -- Product of India --- Mfd in India - Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane, Kolkata 700006
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-0614-2017·2017-04-05

    Claris Fluconazole Injection Recalled for Potential Sterility Breach

    Claris Lifesciences is recalling Fluconazole Injection due to a potential leak that could compromise sterility and contaminate the product.

    Product
    Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-003-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1813-2017·2017-04-05

    Baidyanath Marichyadi Bati Recalled for Heavy Metal Contamination

    Butala Emporium is recalling Baidyanath Marichyadi Bati dietary supplements found to contain lead, mercury, and/or arsenic exceeding permissible limits.

    Product
    Baidyanath brand Marichyadi Bati, Dietary Supplement, 80 Tablets -- Product of India --- Mfd in India - Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane, Kolkata 700006
    Category
    Food
    Distribution
    10 states
  • SevereNHTSA·17V231000·2017-04-05

    E-One Recalls Emergency Vehicles Due to Front Suspension Ball Joint Defect

    E-One is recalling 2013-2016 Quest, Typhoon, and Cyclone II emergency vehicles because front suspension ball joints can loosen and separate, potentially causing a loss of steering control.

    Product
    E-ONE — E-ONE QUEST, TYPHOON, CYCLONE II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1752-2017·2017-04-05

    Cumberland Valley Creamery Recalls Cheddar Cheese for E. coli Contamination

    Cumberland Valley Creamery is recalling 18,585.01 lbs of cheddar cheese in Maryland and Pennsylvania because laboratory analysis found E. coli levels exceeding allowed limits.

    Product
    Cheddar, all varieties unlabeled for repacking and relabeling.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1778-2017·2017-04-05

    Fuji Food Products Recalls Hawaiian Delight for Potential Listeria

    Fuji Food Products is recalling 180 cases of Hawaiian Delight (4.5 lb) due to a potential Listeria monocytogenes contamination. The product was distributed in California.

    Product
    Hawaiian Delight, Net Wt. 4.5lb
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0613-2017·2017-04-05

    Claris Ciprofloxacin Injection Recalled for Potential Sterility Breach

    Claris Lifesciences Inc. is recalling Ciprofloxacin in Dextrose Injection due to a potential leak that may compromise sterility.

    Product
    Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-009-24
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1613-2017·2017-04-05

    FDA Recalls 216 Custom Procedure Trays Due to Glove Splitting Hazard

    Resource Optimization & Innovation LLC is recalling 216 custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800553001, Sterile, OR0642A - Total Knee - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1549-2017·2017-04-05

    Recall of Regard Total Joint Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 208 Regard Total Joint Procedure Kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1622-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 148 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800558002, Sterile, OR0647B - Extremity - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1718-2017·2017-04-05

    B & H Foods Recalls Ruth's Pimento Spread for Listeria Risk

    B & H Foods is recalling Ruth's Original Pimento Spread in 7oz, 12oz, and 24oz sizes due to potential Listeria monocytogenes contamination. The product was distributed in six southeastern states.

    Product
    Ruth's Original Pimento Spread 7oz (UPC 74952-0005), 12oz (UPC 74952-12023) and 24oz (74952-24023), Packed By: B & H Foods, 181 Saluda ST, Chester, SC 29706, packed in plastic containers.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1751-2017·2017-04-05

    Cumberland Valley Creamery Recalls Dutchland Homestead American Cheese for E. coli

    Cumberland Valley Creamery is recalling 401 lbs of Dutchland Homestead American Cheese because laboratory analysis found E. coli levels exceeding allowed limits.

    Product
    Dutchland Homestead, American Cheese, Net Weight 8 oz.., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055;
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1544-2017·2017-04-05

    Resource Optimization Recalls Sterile Robotic Laparoscopic Procedure Trays

    Resource Optimization & Innovation LLC is recalling 41 sterile robotic laparoscopic procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800599003, Sterile, GS0694C - Robotic Lap - Christus Highland
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1455-2017·2017-04-05

    Strata Skin Sciences Recalls XTRAC Excimer Lasers Due to Shorted Wires

    Strata Skin Sciences is recalling XTRAC Excimer Lasers because loose switch control wires may short, leading to unintentional laser firing.

    Product
    XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1642-2017·2017-04-05

    FDA Recalls Sterile C-Section Procedure Kits Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 230 sterile C-section procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800408003, Sterile, LD0477C - C-Section PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1733-2017·2017-04-05

    Bitterman and Sons Recalls Parmesan Truffle Salt for Undeclared Milk Allergen

    Bitterman and Sons is recalling Parmesan Truffle Salt because the label declares Parmigiano Reggiano cheese but fails to list milk as an ingredient.

    Product
    Parmesan Truffle Salt. The product is packaged in glass taster cork jars (0.9 oz.) with cork top lid, glass small jars (1.8 oz.) with glass lids, and glass large jars (6.1 oz.) with glass lids. Sold as single items. The label is read in parts: "***Parmesan Truffle Salt*** INGR
    Category
    Food
    Distribution
    15 states
  • HighFDA (Drugs)·D-0620-2017·2017-04-05

    Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

    Mylan Pharmaceuticals is recalling specific lots of Atorvastatin Calcium 40 mg tablets due to potential microbial contamination and elevated bioburden.

    Product
    Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC 0378-3952-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1629-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 25 kits of Regard custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800562002, Sterile, NU0651B - Neuro - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1633-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation Llc is recalling 71 custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800569002, Sterile, CV0659B - Open Heart A&B - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1600-2017·2017-04-05

    Recall of Regard Sterile Abdominal PK Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation Llc is recalling 200 sterile abdominal procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800533002 Sterile, GS0606B - Abdominal PK - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1578-2017·2017-04-05

    Recall of Regard Sterile Laparotomy Procedure Trays Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 30 sterile laparotomy procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 880342004, Sterile, GS0776D - Laparotomy - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1758-2017·2017-04-05

    Cumberland Valley Creamery Recalls Havarti Caraway Cheese for E. coli

    Cumberland Valley Creamery is recalling Havarti Caraway cheese because laboratory analysis found levels of E. coli exceeding allowed limits.

    Product
    Havarti Caraway, unlabeled, Manufactured for repack and relabel cheeses.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1687-2017·2017-04-05

    Philips V60 Ventilator Recall for False Blower Motor Stall Detection

    Respironics is recalling 2,512 Philips V60 Ventilators with Version 2.20 software because they may falsely detect a blower motor stall, causing the device to shut down and cease ventilatory support.

    Product
    Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator,Intl Opt: CFLEX,AVAPS V60 Ventilator,Intl Opt: None V60 Ventilator,English Opt: None V60 Ventilator,Engl Opt: CFLEX,AVAPS V60 Us Demo Unit V60 USED
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1665-2017·2017-04-05

    Recall of Spohn AV Access Kits Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 306 Spohn AV Access Kits because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800425001, Sterile, CV0494A - AV Access Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1644-2017·2017-04-05

    Recall of Regard Sterile Lap Chole Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 2,016 sterile lap chole procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1614-2017·2017-04-05

    Recall of Regard Sterile Total Knee Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 70 sterile total knee procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800553002, Sterile, OR0642B - Total Knee - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1582-2017·2017-04-05

    FDA Recalls 120 Sterile Total Joint Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 120 sterile Total Joint Procedure Kits because a light glove component may split during use, breaking the sterile field.

    Product
    Regard, Item Number: 800414, Sterile, OR0483 - Total Joint PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1786-2017·2017-04-05

    Kusher LLC Recalls Cookies Prince for Undeclared Milk Allergen

    Kusher LLC is recalling Cookies Prince packages because the label fails to declare milk, a major allergen present in the product as butter.

    Product
    COOKIES PRINCE, product is packaged in plastic clamshells container, Net Weight: 454g (16 OZ), UPC: 8 51929 00360 9 The label is read in parts: "***COOKIES "PRINCE" *** INGREDIENTS: WHEAT FLOUR (WHEAT FLOUR, NIACIN, REDUCE IRON, THIAMINE MONONITRATE, RIBOFLAVIN, FOLIC ACID,
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1602-2017·2017-04-05

    Recall of Regard Sterile Procedure Trays Due to Glove Splitting Hazard

    Resource Optimization & Innovation LLC is recalling 40 kits of Regard sterile procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1626-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 189 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800559002, Sterile, ET0648B - Head & Neck - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1661-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 450 Regard custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800419001, Sterile, GY0488A - D&C Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1684-2017·2017-04-05

    Streck Recalls Cyto-Chex BCT Blood Specimen Collection Tubes

    Streck is recalling 128,692 Cyto-Chex BCT blood specimen collection tubes because the 2.0ml tube stoppers may come loose during phlebotomy if small diameter tube adapters are not used.

    Product
    Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only. Packaged 6-tube pack REF 213559 and 100-tube box REF 218980. Streck.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1559-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 156 Regard custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 880323001, Sterile, LD0754A - C Section - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1563-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation Llc is recalling 48 kits of Regard sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 880327005, Sterile, CV0758E - Open Heart A&B - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1745-2017·2017-04-05

    Cumberland Valley Creamery Recalls Luqman White Cheddar Cheese

    Cumberland Valley Creamery is recalling Luqman White Cheddar cheese due to laboratory findings of E. coli exceeding allowed limits.

    Product
    Luqman Cheese, White Cheddar, Net Wt. 8 oz.., Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1627-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 165 custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800559003, Sterile, ET0648C - Head & Neck - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1763-2017·2017-04-05

    Cumberland Valley Creamery Recalls Luqman Cheese Jalapeno Jack Due to E. coli

    Cumberland Valley Creamery is recalling Luqman Cheese Jalapeno Jack because laboratory analysis found the product exceeded allowed limits of generic E. coli.

    Product
    Luqman Cheese, Jalapeno Jack, Net Wt. 8 oz. Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1605-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation Llc is recalling 276 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800546002, Sterile, GS0635B - Abdominal - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1673-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 30 custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1658-2017·2017-04-05

    Recall of Spohn Laparoscopy Kits Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 92 Spohn laparoscopy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1598-2017·2017-04-05

    Recall of Regard Sterile Lap Chole Kits Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 834 sterile lap chole kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1643-2017·2017-04-05

    Resource Optimization Recalls Sterile C-Section Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 430 sterile C-section kits because a light glove component may split, breaking the sterile field.

    Product
    Regard, Item Number: 800408004, Sterile, LD0477D - C-Section PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1663-2017·2017-04-05

    Recall of Sterile Arthroscopy Kits Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 110 sterile arthroscopy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1599-2017·2017-04-05

    FDA Recalls 460 Sterile Lap Chole Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 460 sterile lap chole procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800528005 Sterile, GS0612E - Lap Chole PK - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1568-2017·2017-04-05

    Recall of Pacemaker Procedure Trays Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 26 sterile pacemaker procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 880328002, Sterile, HT0759B - Pacemaker Pk - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1623-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 150 Regard custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800558003, Sterile, OR0647C - Extremity - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1756-2017·2017-04-05

    Cumberland Valley Creamery Recalls Unlabeled Feta Cheese for E. coli

    Cumberland Valley Creamery is recalling unlabeled feta cheese because laboratory analysis found E. coli levels exceeding allowed limits.

    Product
    Feta, unlabeled, Manufactured for repack and relabel cheeses.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1562-2017·2017-04-05

    Recall of Regard Sterile Major Basin Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 1,548 sterile procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 880326001, Sterile, GS0757A - Major Basin - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1631-2017·2017-04-05

    Recall of Robotic Hysterectomy Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 206 sterile robotic hysterectomy procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800567003, Sterile, GY0656C - Robotic Hysterectomy - Alamo
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1784-2017·2017-04-05

    Kusher LLC Recalls Cookies Assorti Due to Allergen Mislabeling

    Kusher LLC is recalling Cookies Assorti because the packaging failed to list egg and milk in the 'Contains' statement, posing a risk to allergic consumers.

    Product
    Cookies ASSORTI, product is packaged in plastic clamshells container, Net Weight: 454g (16 OZ). UPC: 8 51929 00358 6. The label is read in parts: "***COOKIES "ASSORTI" *** INGREDIENTS: WHEAT FLOUR, NIACIN, REDUCE IRON THIAMINE, MONONITRATE, RIBOFLAVIN, FOLIC ACID, BUTTER (PAST
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1611-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 100 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800551002, Sterile, GS0640B - Lap Chole - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1497-2017·2017-04-05

    Merit Medical Recalls 7F Prelude Short Sheath Introducers Due to Detachment Risk

    Merit Medical Systems is voluntarily recalling 1,265 units of 7F Prelude Short Sheath Introducers because the sheath marker tips may detach during use.

    Product
    7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude¿ Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or art
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1768-2017·2017-04-05

    Cumberland Valley Creamery Recalls Yellow Colby Cheese for E. coli

    Cumberland Valley Creamery is recalling Luqman Cheese, Yellow Colby, because laboratory analysis found the product exceeded allowed limits of generic E. coli.

    Product
    Luqman Cheese, Yellow Colby, Net Wt. 8 oz.., Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1805-2017·2017-04-05

    Freshbev Deep Beet Blend Recalled for Elevated Patulin Levels

    Freshbev LLC is recalling Deep Beet Blend products due to elevated patulin levels. The recall affects 5-gallon containers and 2-oz immunity shots distributed in five states.

    Product
    KEEP REFIGERATED, DEEP BEET Blend 5 Gal, Ripe Liquid Produce
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1594-2017·2017-04-05

    Resource Optimization Recalls 15 Sterile Custom Procedure Trays

    Resource Optimization & Innovation LLC is recalling 15 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1610-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation Llc is recalling 90 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800551001, Sterile, GS0640A - Lap Chole - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1607-2017·2017-04-05

    Recall of Custom Procedure Trays Due to Splitting Light Glove Component

    Resource Optimization & Innovation Llc is recalling 12 custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800549002, Sterile, ET0638B - Head & Neck - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1766-2017·2017-04-05

    Cumberland Valley Creamery Recalls Buffalo Colby Cheese for E. coli

    Cumberland Valley Creamery is recalling Luqman and Dutchland Homestead Buffalo Colby cheese because laboratory tests found E. coli levels exceeding allowed limits.

    Product
    Luqman Cheese, Buffalo Colby, Net Wt. 8 oz. Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA Dutchland Homestead, Buffalo Colby Cheese, Net Weight 8 oz., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0619-2017·2017-04-05

    Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

    Mylan Pharmaceuticals is recalling Atorvastatin Calcium Tablets 20 mg due to potential microbial contamination and elevated bioburden.

    Product
    Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1808-2017·2017-04-05

    La Fe Papa Criollas Yellow Potato Recall Due to Listeria Contamination

    Grace Kennedy Foods USA LLC is recalling La Fe Papa Criollas Yellow Potato due to potential Listeria monocytogenes contamination.

    Product
    La Fe Papa Criollas Yellow Potato Net Wt. 14 oz. Distributed: by La Fe Foods Moonachne, NJ 07074 UPC
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1764-2017·2017-04-05

    Cumberland Valley Creamery Recalls Luqman Yellow Cheddar Cheese for E. coli

    Cumberland Valley Creamery is recalling Luqman Yellow Cheddar Cheese because laboratory analysis found E. coli levels exceeding allowed limits.

    Product
    Luqman Cheese, Yellow Cheddar, Net Wt. 8 oz.,. Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1581-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 96 Regard custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800413003, Sterile, CV0482C - Vascular PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1789-2017·2017-04-05

    Kusher LLC Recalls Shishka Cookies Due to Allergen Labeling Error

    Kusher LLC is recalling Shishka Cookies because the packaging failed to list egg and milk in the 'Contains' statement, despite listing them in the ingredients.

    Product
    COOKIES SHISHKA, product is packaged in plastic clamshells container, Net Weight: 454g (16 OZ), UPC: 8 51929 00362 3. The label is read in parts: "***COOKIES "SHISHKA" *** INGREDIENTS: WHEAT FLOUR (FLOUR, NIACIN, IRON, THIAMINE MONONITRATE, RIBOFLAVIN, FOLIC ACID) ASCORBIC A
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1787-2017·2017-04-05

    Kusher LLC Recalls Cookies Fantazia Due to Undeclared Egg and Milk Allergens

    Kusher LLC is recalling 476 packages of Cookies Fantazia because the label failed to declare egg and milk allergens. The product was distributed in California, Oregon, and Washington.

    Product
    COOKIES FANTAZIA, product is packaged in plastic clamshells container, Net Weight: 454g (16 OZ), UPC: UPC: 8 51929 00361 6 The label is read in parts: "***COOKIES "FANTAZIA" *** INGREDIENTS: WHEAT FLOUR (WHEAT FLOUR, NIACIN, REDUCE IRON, THIAMINE MONONITRATE, RIBOFLAVIN, FOL
    Category
    Food
    Distribution
    3 states

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