1. By Rebecca Moulder GRIT 700
What is a recall?
By Rebecca Moulder
GRIT 700

2. What is FDA’s definition of a recall?
“Recalls are actions taken to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority.”1

3. What products are regulated by FDA?
human drugs
animal drugs
medical devices
radiation-emitting products
vaccines
blood and blood products
transplantable human tissue
animal feed
cosmetics
about 80 percent of the foods eaten in the United States

4. What kinds of products are frequently recalled?
Medical devices
Pharmaceuticals
Foods
Biologics
Consumer products
Including:
Electronics
Clothing
Household items
Toys

5. How are recalls classified?
Dangerous or defective products
May cause serious health problems or death
Examples:
Food containing botulinum toxin
Food with undeclared allergens
A label mix-up on a lifesaving drug
A defective artificial heart valve

6. How are recalls classified?
Class II:
May cause a temporary health problem
May pose only a slight threat of a serious nature
Example:
A drug that is under-strength but that is not used to treat life-threatening situations

7. How are recalls classified?
Class III:
Unlikely to cause any adverse health reaction
Violate FDA labeling or manufacturing laws
Examples:
A minor container defect
Lack of English labeling in a retail food

8. Are there other types of recalls?
A Market Withdrawal occurs when a product has a minor violation that would not be subject to FDA legal action.
The firm removes the product from the market or corrects the violation. withdrawal.

9. Are there other types of recalls?
A Medical Device Safety Alert is issued in situations where a medical device may present an unreasonable risk of substantial harm.
In some cases, these situations also are considered recalls.

10. Are there other types of recalls?
Also classified as recalls by FDA:
Field Corrections
Field Safety Notices
Software Updates
Operator’s Manual Updates
All recalls can also be classified as
Voluntary
FDA Mandated

11. Should you be worried?

12. Should you be worried? Yes and no.
Foodborne illnesses kill over 3,000 people a year in the U.S.
Adverse health events cost billions each year.
Budget cuts to inspection programs allow for safety loop holes.
New legislation gives FDA more power to shut down unsanitary firms.

13. What food products are currently being recalled?

14. What were the top food outbreaks of 2012?
This slideshow from WebMD shows the most significant foodborne illness outbreaks of the past year.
Major Foodborne Illness Outbreaks of 2012

15. What are your concerns about recalls?

16. How can I prevent foodborne illness?
There’s got to be a way to keep from getting sick!

17. Video
Check Your Steps: Clean, Separate, Cook, & Chill

18. Where can I find more information?
Increase your food safety education: USDA Food Safety and Inspection Service Current medical device, pharmaceutical, and biologic recalls: FDA Medical Device Safety Recall List Consumer Product Recalls: Consumer Product Safety Commission

19. Sources
1. United States. Food and Drug Administration. Recalls, Market Withdrawals, & Safety Alerts. Background and Definitions. Available from Internet:
2. United States. Consumer Product Safety Commission. Latest recalls. Available from Internet:
3. United States. Department of Agriculture. Food Safety and Inspection Service. Food Safety Education. “Check Your Steps.” Available from Internet:
4. Major foodborne illness outbreaks of Medscape. WebMD Available from Internet:

20. Thank you for watching!