Compact News: 2015-08-23

Thursday, August 27, 2015

Insulet Corporation Issues Voluntary Recall of OmniPod Insulin Management System

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Insulet Corporation Issues Voluntary Recall of OmniPod Insulin Management System

08/27/2015 06:06 PM EDT

On July 8, 2015, Insulet Corporation (Insulet or the Company) initiated a lot-specific voluntary recall of 40,846 boxes (10 Pods per box) of the OmniPod (Pod) Insulin Management System. This field corrective action is due to the possibility that some of the Pods from these lots may have a higher rate of failure than Insulet's current manufacturing standards.

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The One Minute Miracle Inc. Issues Voluntary Nationwide Recall of MIRACLE DIET 30 Due to Presence of Undeclared Phenolphthalein & MIRACLE ROCK 48 Due to Presence of Undeclared Thiosildenafil

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The One Minute Miracle Inc. Issues Voluntary Nationwide Recall of MIRACLE DIET 30 Due to Presence of Undeclared Phenolphthalein & MIRACLE ROCK 48 Due to Presence of Undeclared Thiosildenafil

08/27/2015 03:29 PM EDT

The One Minute Miracle Inc. is voluntarily recalling one lot each of Miracle Diet 30, capsules and Miracle Rock 48. Miracle Diet 30 has been found to contain undeclared phenolphthalein, phenolphthalein was an ingredient used in over-the counter laxatives but was removed from the market because of concerns of carcinogenicity.

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News From CPSC: 1 Recall Announced Today

-----------NEWS from CPSC-----------
U.S. Consumer Product Safety Commission
Office of Communications
4330 East West Highway, Bethesda, MD 20814
www.cpsc.gov

1.Huffy Recalls Bicycles with Front Disc Brakes to Replace Quick Release Lever Due to Crash Hazard

http://www.cpsc.gov/en/Recalls/2015/Huffy-Recalls-Bicycles-with-Front-Disc-Brakes/

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Recall Date: August 27, 2015

Recall Number: 15-221

Huffy Recalls Bicycles with Front Disc Brakes to Replace Quick Release Lever Due to Crash Hazard

http://www.cpsc.gov/en/Recalls/2015/Huffy-Recalls-Bicycles-with-Front-Disc-Brakes/

Recall Summary

Name of Product: Huffy bicycles equipped with front disc brakes

Hazard: An open quick release lever on the bicycle’s front wheel hub can come into contact with the front disc brake assembly, causing the front wheel to come to a sudden stop or separate from the bicycle, posing a risk of injury to the rider.

Remedy: Replace

Consumers should stop using the bicycles immediately and contact Huffy for a free replacement quick release lever for the front wheel.

Consumer Contact: Huffy toll-free at 888-366-3828 from 8 a.m. to 8 p.m. ET Monday through Friday, email Service@Huffy.com or online at www.huffybikes.com and click on “Recalls” at the bottom of any page.

Photos available at http://www.cpsc.gov/en/Recalls/2015/Huffy-Recalls-Bicycles-with-Front-Disc-Brakes/

Recall Details

Units: About 460

Description: The recalled products are all model year 2014 Huffy TR 745 and TR-S 740 bicycles with 27.5-inch wheels. “Huffy” is on the downtube of the frame of both bicycles and model name TR 745 or TR-S 740 is on the rear portion of the frame. The TR 745 has a green frame with model number 26504M on the bottom of the frame near the pedals. The TR-S 740 has a white frame and model number 26604M on the bottom of the frame near the pedals. Bicycles that have a green dot on the inside of the quick release lever are not included in this recall.

Incidents/Injuries: None reported

Sold at: Walmart.com, Sears Puerto Rico and The Northwest Company (Cost U Less) from September 2014 through May 2015 for between $250 to $370.

Manufactured in: China

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The U.S. Consumer Product Safety Commission (CPSC) is still interested in receiving incident or injury reports that are either directly related to a product recall or involve a different hazard with the same product. Please tell us about your experience with the product on SaferProducts.gov.

Media Contact

Please use the phone numbers below for all media requests.

Phone: (301) 504-7908

Spanish: (301) 504-7800

CPSC Consumer Information Hotline

800-638-2772 (TTY 301-595-7054)

Times: 8 a.m. � 5:30 p.m. ET; Messages can be left anytime

Call to get product safety and other agency information and to report unsafe products.

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CDC Press Release: State exemption levels low, national vaccination rates high

Press Release

For Immediate Release

Contact: CDC Media Relations

(404) 639-3286

State exemption levels low, national vaccination rates high

Local pockets of unvaccinated children can reveal nation’s vulnerabilities

Vaccine exemption levels for kindergarteners are low for most states and infant vaccination rates are high nationally, according to data from two reports published in this week’s Morbidity and Mortality Weekly Report (MMWR).

The first report looked at vaccination coverage and exemption levels among children entering kindergarten for the 2014-2015 school year. Nationally, exemption levels remain low with a median level of 1.7 percent. However, state exemption levels ranged from a low of less than 0.1 percent in Mississippi to a high of 6.5 percent in Idaho. Additionally, five states did not meet the reporting standards for providing exemption data.

The second report examined vaccination rates among children ages 19 months through 35 months for 2014. Vaccination coverage remained high: over 90 percent for measles-mumps-rubella (MMR); polio; hepatitis B; and varicella vaccines. The percentage of children who do not receive vaccinations also remained low, at less than 1 percent.

“Collaborative efforts are the reason our nation has been able to achieve such high coverage nationally, but much work is still needed to shield our schools and communities from future outbreaks,” said Anne Schuchat, MD (RADM, USPHS), director of CDC’s National Center for Immunization and Respiratory Diseases.

One important change from 2013 to 2014 was the number of states that provided local coverage and exemption data online. There was an increase from 18 states providing such data in 2013 to 21 states providing these data in 2014. Making this information available publicly keeps parents informed, guides vaccination policies, and strengthens immunization programs.

When a disease like measles reaches a community with large numbers of unvaccinated people, it can spread very quickly. Therefore, local pockets of people who are missing vaccinations can leave communities vulnerable to outbreaks.

Consistent, high coverage rates are needed to provide community immunity (herd immunity) and protect children from disease outbreaks like measles.

The CDC recommends that all children be vaccinated according to the recommended schedule. Parents with questions or concerns should talk with their child’s doctor or visit CDC’s vaccine website for parents at www.cdc.gov/vaccines/parents.

Today's articles will be available on the Morbidity and Mortality Weekly Report website at http://www.cdc.gov/mmwr/ after the embargo lifts at 1:00 p.m. ET.

For more information on the National Immunization Survey (NIS), please visit: http://www.cdc.gov/vaccines/imz-managers/nis/index.html

CDC’s vaccine website for parents: www.cdc.gov/vaccines/parents

Provider Resources for Vaccine Conversations with Parents: www.cdc.gov/vaccines/conversations

Measles www.cdc.gov/measles

Learn More >>

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U.S. Department of Health and Human Services

CDC works 24/7 protecting America’s health, safety and security. Whether diseases start at home or abroad, are curable or preventable, chronic or acute, stem from human error or deliberate attack, CDC is committed to respond to America’s most pressing health challenges.

CDC 24/7 - Saving Lives, Protecting People, Saving Money. CDC.gov/24-7

Learn Vital Information about Making Health Care Safer

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CDC Press Release: America’s schools make positive changes to create healthier school meals

Press Release

For Immediate Release

Contact: CDC Media Relations

(404) 639-3286

America’s schools make positive changes to create healthier school meals

More fruits and vegetables offered -- less sodium used

Most schools in the U.S. are implementing healthy practices to help meet federal school meal standards by offering whole grains, more fruits and vegetables, and reducing sodium content, according to data published today in the Centers for Disease Control and Prevention’s (CDC) Morbidity and Mortality Weekly Report. School meal programs are an important source of nutrition as students consume almost half of their daily calories at school.

CDC researchers analyzed school-level data from the School Health Policies and Practices Study (SHPPS) for 2000, 2006, and 2014 to see how well schools are implementing practices related to the nutrition standards for school meals published by the U.S. Department of Agriculture in 2012. The standards require serving more fruits, vegetables, and whole grains and gradually reducing sodium over 10 years. Previous studies have shown that students who eat school meals consume more milk, fruits, and vegetables during school meal times and have better intake of some key nutrients (such as calcium and fiber) than those who do not participate in the meal programs.

“School meals are healthier now than ever before. We’ve made real progress, but there is much more to do to help American children make food choices that will keep them healthy throughout their lives,” said CDC Director Tom Frieden, M.D., M.P.H.

Between 2000 and 2014, the percentage of schools implementing five of the nine school nutrition services practices examined has increased significantly.

Key Findings from 2014:

Almost all schools offered whole grains each day for breakfast (97.2 percent) and lunch (94.4 percent).
Most schools offered two or more vegetables (79.4 percent, up from 61.7 percent in 2000) and two or more fruits (78.0 percent, up from 68.1 percent in 2000) each day for lunch.
Nearly one-third (30.5 percent) of schools offered self-serve salad bars.
More than half of schools that prepared their meals at the school used fresh or frozen vegetables instead of canned (54.1 percent), used low-sodium canned vegetables instead of regular canned vegetables (51.8 percent, up from 10.3 percent in 2000), used other seasonings instead of salt (65.1 percent up from 32.8 percent in 2000), and reduced the amount of sodium called for in recipes or used low-sodium recipes (68.0 percent up from 34.1 percent in 2000).

“We are encouraged that more schools are offering a variety of fruits and vegetables and finding ways to reduce the sodium content of school meals,” said Caitlin Merlo, M.P.H., lead author of the study and health scientist in CDC’s School Health Branch. “Schools play a critical role in demonstrating and reinforcing healthy eating behaviors by making sure that nutritious and appealing foods and beverages are available and promoted to students. This is particularly important because children’s eating patterns carry into adulthood.”

Improvement still needed

Although schools are moving in the right direction, there are many ways to further increase fruit and vegetable availability and reduce sodium in school foods.

Strategies to improve school nutrition services practices:

Schools can assess their nutrition policies and practices by completing CDC’s School Health Index and implement strategies found in CDC’s School Health Guidelines to Promote Healthy Eating and Physical Activity.
School officials can ensure schools have appropriate equipment to prepare and serve fruits and vegetables (for example, food processors, knife sets with cutting boards, and refrigerators).
Schools can participate in partnerships like Let’s Move Salad Bars to Schools.
Districts and schools can work with CDC-funded staff in state health departments (State Public Health Actions) to offer ongoing training for school-nutrition professionals, and to provide resource materials to school administrators, teachers, and parents to further improve school nutrition practices and support the meal programs.

U.S. schools have significantly improved school nutrition practices and should continue striving to provide a quality nutrition environment for students. For more information about CDC’s Healthy Schools activities, visit http://www.cdc.gov/HealthyYouth/.

Learn More>>

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U.S. Department of Health and Human Services

Preventive health care can help Americans stay healthier throughout their lives. Those enrolled in health insurance coverage can use the “Roadmap to Better Care and a Healthier You” (English and Spanish) to learn about their benefits, including how to connect to primary care and the preventive services that are right for them, so that they can live a long and healthy life.

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Bimbo Bakeries Voluntary Regional Recall of Certain Limited Breads Produced Under the Sara Lee, Great Value, Kroger, Bimbo, Nature’s Harvest and L’Oven Fresh Brands

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Bimbo Bakeries Voluntary Regional Recall of Certain Limited Breads Produced Under the Sara Lee, Great Value, Kroger, Bimbo, Nature’s Harvest and L’Oven Fresh Brands

08/27/2015 12:41 PM EDT

Bimbo Bakeries USA has initiated a voluntary regional recall of certain bread products under the Sara Lee®, Kroger®, Bimbo®, Nature’s Harvest®, Great Value and L’Oven Fresh® brands due to the possible presence of fragments of glass caused by a broken light bulb at one of its bakeries.

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General Mills voluntarily recalls a limited quantity of frozen Cascadian Farm Cut Green Beans

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General Mills voluntarily recalls a limited quantity of frozen Cascadian Farm Cut Green Beans

08/26/2015 04:49 PM EDT

General Mills today announced a voluntary Class I recall of a limited quantity of frozen Cascadian Farm Cut Green Beans produced over two days in March 2014. The recall is being issued as a precaution after one package of finished product tested positive for the presence of Listeria monocytogenes.

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Wednesday, August 26, 2015

Novacare, LLC Issues Voluntary Nationwide Recall of Dietary Supplements Due to Undeclared Salicylic Acid

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Novacare, LLC Issues Voluntary Nationwide Recall of Dietary Supplements Due to Undeclared Salicylic Acid

08/26/2015 12:48 PM EDT

Novacare, LLC of Murray, Utah is voluntarily recalling all lots of the following dietary supplements to the consumer level

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Sid Wainer and Son Recalls Jansal Valley Raw Macadamia Nuts Due to Possible Health Risk

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Sid Wainer and Son Recalls Jansal Valley Raw Macadamia Nuts Due to Possible Health Risk

08/26/2015 01:45 PM EDT

Sid Wainer and Son of New Bedford, MA is voluntarily recalling Jansal Valley brand Raw Macadamia Nuts, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

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Recall Sam Mills Gluten Free Chocolate Chip Granola Bar

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Recall Sam Mills Gluten Free Chocolate Chip Granola Bar

08/26/2015 02:06 PM EDT

Sam Mills USA LLC is voluntarily recalling approximately 11,083 cases of - 4.4 ounce boxes of Gluten Free Chocolate Chip Granola Bars because of a risk of cross contamination with Dairy. The recall is being initiated because the Sam Mills Gluten Free Chocolate Chip Granola Bar packaging states that this is a Dairy free product and in fact it should be labeled that in “May contain Traces of Dairy”.

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News From CPSC: 4 Recalls Announced Today

-----------NEWS from CPSC-----------
U.S. Consumer Product Safety Commission
Office of Communications
4330 East West Highway, Bethesda, MD 20814
www.cpsc.gov

1. Trek Recalls Superfly Bicycles Due to Fall Hazard; Seatpost Can Crack and Break

http://www.cpsc.gov/en/Recalls/2015/Trek-Recalls-Superfly-Bicycles/

2. CAMP USA Recalls Blade Runner Crampons Due to Fall Hazard

http://www.cpsc.gov/en/Recalls/2015/CAMP-USA-Recalls-Blade-Runner-Crampons/

3. CAMP USA Recalls Tour Nanotech Crampons Due to Fall Hazard

http://www.cpsc.gov/en/Recalls/2015/CAMP-USA-Recalls-Tour-Nanotech-Crampons/

4. Robert Bosch Tool Recalls Dremel Rotary Tool Due to Burn Hazard

http://www.cpsc.gov/en/Recalls/2015/Robert-Bosch-Tool-Recalls-Dremel-Rotary-Tool/

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1. Recall Date: August 26, 2015

Recall Number: 15-224

Trek Recalls Superfly Bicycles Due to Fall Hazard; Seatpost Can Crack and Break

http://www.cpsc.gov/en/Recalls/2015/Trek-Recalls-Superfly-Bicycles/

Recall Summary

Name of Product: Trek 9.8 Superfly FS SL, X1 and XT bicycles

Hazard: The seatpost can crack and break, posing a fall hazard to the rider.

Remedy: Replace

Consumers should immediately stop using the recalled bicycles and contact an authorized Trek retailer for a free replacement seatpost plus a $20 coupon toward any Bontrager merchandise. The coupon can be used through December 31, 2015.

Consumer Contact: Trek at 800-373-4594 from 8 a.m. to 6 p.m. CT Monday through Friday, or online at www.trekbikes.com and click on Safety & Recalls at the bottom of the page for more information.

Photos available at http://www.cpsc.gov/en/Recalls/2015/Trek-Recalls-Superfly-Bicycles/

Recall Details

Units: About 330

Description: This recall involves model year 2015 Trek 9.8 Superfly FS SL, X1 and XT bicycles equipped with Bontrager Approved Carbon seatposts. Recalled bicycles have a serial number ending in J or K. The serial number is located on the bottom of the bicycle frame. Superfly FS, X1 or XT is printed on the bicycle’s top tube. Trek is printed on the frame downtube. “Bontrager Carbon” is printed on the seatpost.

Incidents/Injuries: Trek has received two incidents report involving the recalled bicycles. No injuries have been reported.

Sold at: Bicycle stores nationwide from September 2014 through July 2015 for about $5,300 for the FS SL and about $3,500 for the X1 and XT bicycles.

Importer: Trek Bicycle Corporation, of Waterloo, Wis.

Manufactured in: Taiwan

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2. Recall Date: August 26, 2015

Recall Number: 15-225

CAMP USA Recalls Blade Runner Crampons Due to Fall Hazard

http://www.cpsc.gov/en/Recalls/2015/CAMP-USA-Recalls-Blade-Runner-Crampons/

Recall Summary

Name of Product: Cassin Blade Runner and Blade Runner Alpine Crampons

Hazard: The front part, where the points connect to the crampons, can break, posing a fall hazard.

Remedy: Repair

Consumers should immediately stop using these recalled crampons and contact the firm for instructions on receiving free replacement parts.

Consumer Contact: CAMP USA toll-free at 877-421-2267 from 9 a.m. to 5 p.m. MT Monday through Friday or online at www.camp-usa.com and click on the Safety Notices link at the bottom of the page then click on Blade Runner Crampon for more information.

Photos available at http://www.cpsc.gov/en/Recalls/2015/CAMP-USA-Recalls-Blade-Runner-Crampons/

Recall Details

Units: About 900 (in addition, 20 were sold in Canada)

Description: This recall involves all Cassin Blade Runner and Blade Runner Alpine crampons. Crampons are used for ice climbing and attach to footwear allowing the front points of the crampon to cut into the snow or ice. The Blade Runner crampons have two ice front points and the Blade Runner Alpine crampons have two snow front points. “Sandvik Nanoflex” is printed on a rubber label attached to the gray nylon ankle strap. “Cassin” and “Blade Runner” are stamped on the orange traction plate on the foot of the crampon. The crampon frames are made of Chromoly and Nanoflex® steel.

Incidents/Injuries: CAMP USA has received three reports of these crampons breaking during use. No injuries have been reported.

Sold at: Specialty outdoor retailers nationwide and online at backcountry.com, camp-usa.com and mountaingear.com from June 2013 to June 2015 for about $350.

Importer/Distributor: CAMP USA Inc., of Broomfield, Colo.

Manufactured in: Italy

Note: Health Canada’s press release is available at http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/54802r-eng.php

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3. Recall Date: August 26, 2015

Recall Number: 15-226

CAMP USA Recalls Tour Nanotech Crampons Due to Fall Hazard

http://www.cpsc.gov/en/Recalls/2015/CAMP-USA-Recalls-Tour-Nanotech-Crampons/

Recall Summary

Name of Product: Tour Nanotech Automatic and Semi-Automatic Crampons

Hazard: The heel bail which connects the ankle strap to the crampon can detach from the crampon, posing a fall hazard.

Remedy: Replace

Consumers should immediately stop using the recalled product and contact the firm for a free pair of replacement crampons.

Photos available at http://www.cpsc.gov/en/Recalls/2015/CAMP-USA-Recalls-Tour-Nanotech-Crampons/

Recall Details

Units: About 500 (in addition, 19 units sold in Canada)

Description: This recall affects all Tour Nanotech Automatic and Semi-Automatic crampons. Both crampons are made of steel plates that attach to boots for ice climbing. The Tour Nanotech Automatic has a red heel bail with a gray strap that fastens around the ankle. The Tour Nanotech Semi-Automatic has a red toe strap at the front of the crampon and a red heel bail at the back. A gray strap is connected to both heel bails and fastens around the boot.

Incidents/Injuries: CAMP USA has received one report of the heel bail detaching during use. No injuries have been reported.

Sold at: Specialty outdoor retailers and online at backcountry.com, camp-usa.com and mountaingear.com from June 2013 to June 2015 for about $220.

Importer/Distributor: CAMP USA Inc., of Broomfield, Colo.

Manufactured in: Italy

Note: Health Canada’s press release is available at http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/54800r-eng.php

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4. Recall Date: August 26, 2015

Recall Number: 15-227

Robert Bosch Tool Recalls Dremel Rotary Tool Due to Burn Hazard

http://www.cpsc.gov/en/Recalls/2015/Robert-Bosch-Tool-Recalls-Dremel-Rotary-Tool/

Recall Summary

Name of Product: Dremel® MICRO™ Model 8050 Rotary Tool

Hazard: The tool’s circuit board can overheat and melt the tool’s enclosure. If the tool is being held while overheating, it could present a risk of burn. Additionally, some tools may lose their speed control changing to high speed in use, turn on by themselves, or may not turn off, posing a personal injury hazard.

Remedy: Repair

Consumers should immediately contact Robert Bosch Tool for information on a free repair.

Consumer Contact: Robert Bosch Tool Corp. toll-free at 855-866-1291 between 7 a.m. and 7 p.m. CT Monday through Friday, or online at www.dremel.com and click on “Customer Service & Safety Information” for more information.

Photos available at http://www.cpsc.gov/en/Recalls/2015/Robert-Bosch-Tool-Recalls-Dremel-Rotary-Tool/

Recall Details

Units: About 93,000 (an additional 2750 sold in Canada)

Description: This recall involves the Dremel® MICRO™ Model 8050 Rotary Tool with date codes 407 through 505. The model number and date codes are located on the name plate of the product, which is on the side opposite the Dremel logo. Products are dark gray with a silver label and blue control buttons and have 8V lithium ion batteries.

Incidents/Injuries: Bosch Tool has received six reports from consumers of tools overheating. There are no reports of injuries.

Sold at: Ace Hardware, Home Depot, Lowe’s, Menards and other home improvement, hardware and major retailers nationwide and online including www.acehardware.com, www.amazon.com, www.homedepot.com, www.lowes.com and www.menards.com from July 2014 through May 2015 for about $90.

Importer/Distributor: Robert Bosch Tool Corp., of Mount Prospect, Ill.

Manufactured in: Mexico

Note: Health Canada’s press release is available at http://http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/54734r-eng.php.

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Media Contact

Please use the phone numbers below for all media requests.

Phone: (301) 504-7908

Spanish: (301) 504-7800

CPSC Consumer Information Hotline

800-638-2772 (TTY 301-595-7054)

Times: 8 a.m. � 5:30 p.m. ET; Messages can be left anytime

Call to get product safety and other agency information and to report unsafe products.

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Compact News

Thursday, August 27, 2015

Insulet Corporation Issues Voluntary Recall of OmniPod Insulin Management System

The One Minute Miracle Inc. Issues Voluntary Nationwide Recall of MIRACLE DIET 30 Due to Presence of Undeclared Phenolphthalein & MIRACLE ROCK 48 Due to Presence of Undeclared Thiosildenafil

News From CPSC: 1 Recall Announced Today

CDC Press Release: State exemption levels low, national vaccination rates high

CDC Press Release: America’s schools make positive changes to create healthier school meals

Bimbo Bakeries Voluntary Regional Recall of Certain Limited Breads Produced Under the Sara Lee, Great Value, Kroger, Bimbo, Nature’s Harvest and L’Oven Fresh Brands

General Mills voluntarily recalls a limited quantity of frozen Cascadian Farm Cut Green Beans

Wednesday, August 26, 2015

Novacare, LLC Issues Voluntary Nationwide Recall of Dietary Supplements Due to Undeclared Salicylic Acid

Sid Wainer and Son Recalls Jansal Valley Raw Macadamia Nuts Due to Possible Health Risk

Recall Sam Mills Gluten Free Chocolate Chip Granola Bar

News From CPSC: 4 Recalls Announced Today

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