The Recall Desk

Archive

April 2017 recalls

850 recalls were announced in April 2017.

What the numbers show

Critical
98
Severe
177
High
432
Moderate
121
Low
22

Of the 850 recalls this month scored against our rubric, 12% are Critical, 21% are Severe.

601–700 of 850

  • CriticalFDA (Food)·F-1727-2017·2017-04-05

    Seaquest Recalls Marinated Croaker Fish Due to Botulism Risk

    Seaquest Seafood Corp is recalling Sunrise Brand Marinated Silver/White Croaker because the product may be contaminated with Clostridium botulinum.

    Product
    Sunrise Brand Marinated Silver/White Croaker - 30 x 14oz, Item No. C0081, UPC 5 08 54336-50081 0
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1729-2017·2017-04-05

    Seaquest Recalls Marinated River Barb Fish Due to Botulism Risk

    Seaquest Seafood Corp is recalling Sunrise Brand Marinated River Barb because it may be contaminated with Clostridium botulinum.

    Product
    Sunrise Brand Marinated River Barb - 60 x 10 oz, Item No. C0140, UPC 2 08 54336-20140 2
    Category
    Food
    Distribution
    0 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 (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-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 (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-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 (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
  • 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-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
  • 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 (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-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 (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 (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
  • 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 (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 (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…
    Category
    Medical Device
    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
  • 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 (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-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-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-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-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 (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 (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 (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-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-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)…
    Category
    Food
    Distribution
    3 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-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 (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 (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
  • 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 (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    Category
    Food
    Distribution
    3 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 (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 (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 (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
  • 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 (Devices)·Z-1639-2017·2017-04-05

    Recall of Regard Sterile Lap PK Spohn Custom Procedure Trays

    Resource Optimization & Innovation LLC is recalling 3,000 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800401002, Sterile, GS0470B - Lap PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1761-2017·2017-04-05

    Cumberland Valley Creamery Recalls Unlabeled Cheeses for E. coli

    Cumberland Valley Creamery is recalling 4,619 lbs of unlabeled cheeses in Maryland and Pennsylvania because laboratory analysis found E. coli levels exceeding allowed limits.

    Product
    Udder Delight, unlabeled, Manufactured for repack and relabel cheeses.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1656-2017·2017-04-05

    Recall of Robotic Hysterectomy Kits Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 249 sterile robotic hysterectomy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - Spohn
    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 (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-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 (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-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 (Food)·F-1769-2017·2017-04-05

    Dutchland Homestead Colby Jack Cheese Recalled for E. coli Contamination

    Cumberland Valley Creamery is recalling Dutchland Homestead Colby Jack Cheese because laboratory analysis found E. coli levels exceeding allowed limits.

    Product
    Dutchland Homestead, Colby Jack Cheese, Net Weight 8 oz., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1762-2017·2017-04-05

    Cumberland Valley Creamery Recalls Unlabeled Colby Cheeses for E. coli

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

    Product
    Colby cheeses various, unlabeled, Manufactured for repack and relabel cheeses.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1781-2017·2017-04-05

    Azteca Milling Recalls Corn Masa Flour Due to Metal Fragments

    Azteca Milling LP is recalling 30,100 lbs of Taco 6 White NGMO Corn Masa Flour because customers reported the product contains metal fragments.

    Product
    Taco 6 White NGMO Corn Masa Flour 50 lb bags
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-1772-2017·2017-04-05

    Dutchland Homestead Cheddar Cheese Recalled for E. coli Contamination

    Cumberland Valley Creamery is recalling Dutchland Homestead Cheddar Cheese because laboratory tests found E. coli levels exceeding allowed limits.

    Product
    Dutchland Homestead, Cheddar Cheese, Net Weight 8 oz., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1683-2017·2017-04-05

    National Biological Hand Foot II UVB-138 Phototherapy Devices Recalled for Wiring Defect

    National Biological Corp is recalling seven Hand Foot II, UVB-138 phototherapy devices because wiring defects may allow lamps to turn on with the key switch rather than the timer.

    Product
    Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a corrugated box. For UV phototherapy treatment.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1624-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 280 sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 800558004, Sterile, OR0647D - Extremity - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1760-2017·2017-04-05

    Cumberland Valley Creamery Recalls Unlabeled Monterey Jack Cheese for E. coli

    Cumberland Valley Creamery is recalling unlabeled Monterey Jack cheese because laboratory analysis found levels of generic E. coli exceeding allowed limits.

    Product
    Monterey Jack various, unlabeled, Manufactured for repack and relabel cheeses.
    Category
    Food
    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-1682-2017·2017-04-05

    Hospira Plum 360 Infusion Pump Software Recall for Battery Alarm Defect

    Hospira is recalling 62,847 Plum 360 Infusion Pumps with software version 15.02 due to a defect that causes therapy to stop and incorrect alarms to display.

    Product
    Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1619-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 356 Regard custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800557001, Sterile, LD0646A - C Section - Childrens 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-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 (Devices)·Z-1697-2017·2017-04-05

    Merge Healthcare Recalls iConnect Enterprise Archive Software Due to Data Access Issues

    Merge Healthcare is recalling iConnect Enterprise Archive software because archived studies cannot be opened or sent to PACS, preventing physicians from reviewing comparison studies.

    Product
    iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1674-2017·2017-04-05

    Recall of Regard Sterile Abdominal Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 210 sterile abdominal procedure kits because a light glove component may split during use, breaking the sterile field.

    Product
    Regard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1747-2017·2017-04-05

    Cumberland Valley Creamery Recalls Mozzarella for E. coli Contamination

    Cumberland Valley Creamery is recalling Dutchland Homestead Mozzarella because laboratory analysis found E. coli levels exceeding allowed limits.

    Product
    Dutchland Homestead Mozzarella, Net Weight 8 oz., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1601-2017·2017-04-05

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

    Resource Optimization & Innovation Llc is recalling 290 sterile abdominal procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800533003 Sterile, GS0606C - Abdominal PK - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1577-2017·2017-04-05

    Recall of Regard Sterile Laparotomy Kits Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 78 sterile laparotomy kits because a light glove component may split, breaking the sterile field.

    Product
    Regard, Item Number: 880342003, Sterile, GS0776C - Laparotomy - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1640-2017·2017-04-05

    Recall of Regard Sterile Ortho PK Spohn Procedure Trays

    Resource Optimization & Innovation LLC is recalling 840 sterile procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800407004, Sterile, OR0476D - Ortho PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1664-2017·2017-04-05

    Recall of Sterile Arthroscopy Kits Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 162 sterile arthroscopy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800422004, Sterile, OR0491D - Arthroscopy Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1666-2017·2017-04-05

    Recall of Spohn AV Access Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 118 Spohn AV Access Procedure Kits because a light glove component may split during use, breaking the sterile field.

    Product
    Regard, Item Number: 800425002, Sterile, CV0494B - AV Access Pk - Spohn
    Category
    Medical Device
    Distribution
    2 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-1659-2017·2017-04-05

    Recall of Regard Sterile Vaginal Kits Due to Glove Splitting Hazard

    Resource Optimization & Innovation LLC is recalling 148 sterile vaginal kits because a light glove component may split, breaking the sterile field.

    Product
    Regard, Item Number: 800418002, Sterile, GY0487B - Major Vaginal Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1630-2017·2017-04-05

    FDA Recalls Robotic Hysterectomy Kits Due to Sterile Field Breach Risk

    Resource Optimization & Innovation LLC is recalling 236 robotic hysterectomy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800567002, Sterile, GY0656B- Robotic Hysterectomy - Alamo
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1606-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 180 custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800548002, Sterile, OR0637B - Extremity - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1634-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation Llc is recalling 25 sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 800569003, Sterile, CV0659C - Open Heart A&B - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 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…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1636-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 92 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1560-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

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

    Product
    Regard, Item Number: 880323002, Sterile, LD0754B - C Section - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1588-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 70 kits of Regard sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 800524002, Sterile, LD0608B - C Section - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1618-2017·2017-04-05

    Recall of Pediatric Cardiac Catheterization Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 27 pediatric cardiac catheterization trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800555002, Sterile, HT0644B - Pediatric Card Cath - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1755-2017·2017-04-05

    Cumberland Valley Creamery Recalls Unlabeled Gouda Cheese for E. coli

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

    Product
    Gouda, unlabeled, Manufactured for repack and relabel cheeses.
    Category
    Food
    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-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-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-1546-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 210 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800560003, Sterile, GS0649C - Lap Chole - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1573-2017·2017-04-05

    Resource Optimization Recalls Sterile Total Knee Procedure Trays Due to Glove Defect

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

    Product
    Regard, Item Number: 880331002, Sterile, OR0762B - Total Knee - OSU
    Category
    Medical Device
    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 (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-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 (Devices)·Z-1556-2017·2017-04-05

    FDA Recalls Sterile Custom Procedure Trays Due to Glove Splitting Risk

    Resource Optimization & Innovation Llc is recalling 46 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800091003, Sterile, LD0692C - C Section - FMOL Lady of Angels
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1550-201·2017-04-05

    Recall of VP Shunt Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 55 VP Shunt procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800566002, Sterile, NU0655B - VP Shunt - Childrens 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 (Devices)·Z-1585-2017·2017-04-05

    Recall of Spohn Arthroscopy Kits Due to Splitting Light Glove Component

    Resource Optimization & Innovation LLC is recalling 36 sterile arthroscopy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800422002, Sterile, OR0491B - Arthroscopy PK - Spohn
    Category
    Medical Device
    Distribution
    2 states

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