Food Safety and Inspection Service

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July 2017 1 
Food Safety and Inspection Service:

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Food Safety and Inspection Service

FSIS Recall Overview

Recall Management and Technical Analysis Division

Office of Field Operations

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Food Safety and Inspection Service:

Click to edit Master title style What is a recall?

At FSIS, a recall is a firm’s voluntary removal of 

distributed meat, poultry, or egg products from 

commerce when there is reason to believe those 

products are adulterated or misbranded under 

the provisions of the Federal Meat Inspection 

Act (FMIA), Poultry Products Inspection Act 

(PPIA), or Egg Products Inspection Act (EPIA). 

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Food Safety and Inspection Service:

Click to edit Master title style Why does FSIS ask firms to recall product?

• Illness outbreaks

• Undeclared allergens

• Products produced 

without inspection

• Products imported 

without inspection

• Drug residues

• STECs

• Listeria monocytogenes or 

Salmonella in Ready to Eat 

Foods

• Foreign matter

• Others

When an official 

establishment believes it has 

shipped adulterated or 

misbranded product, it must 

inform the District Office 

(DO) of the type, amount, 

origin, and destination of the 

product within 24 hours of 

learning of the problem. 

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Food Safety and Inspection Service:

Click to edit Master title style What are the classifications for FSIS product recalls?

• Class I: reasonable probability of serious, 

adverse health consequences or death 

• Class II: remote probability of adverse health 

consequences 

• Class III: will not cause adverse health 

consequences

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Food Safety and Inspection Service:

Click to edit Master title style What are the steps involved in the recall process?

FSIS Directive 8080.1: Recall of Meat and Poultry 

Products provides the terminology, 

responsibilities, and public notification 

procedures regarding the voluntary recall of 

FSIS-regulated products 

Problem 

Identification

Preliminary 

Investigation

Recall 

Deliberations

Notifications 

& Actions

Recall 

Closure

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Note: RMTAD may decide to hold a preliminary call (pre-call) to discuss unique 

or atypical situations to consolidate information, clarify expectations, and 

inform decision making. This may include FSIS program areas, partner 

agencies, or establishments.
Food Safety and Inspection Service:

Click to edit Master title style How does FSIS learn of a potential recall? Problem Identification

FSIS may become aware of misbranded or 

adulterated product in commerce through its own 

resources or through other sources. For example: 

– The company

– FSIS sampling results

– Observations or information gathered by FSIS 

inspection program personnel

– Consumer complaints

– Epidemiological or laboratory data submitted by 

public health departments or other agencies

– Other agencies such as the Food and Drug 

Administration, Department of Homeland Security, 

USDA agencies, or foreign inspection officials

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Food Safety and Inspection Service:

Click to edit Master title style Who conducts the preliminary investigation?

• Typically, FSIS inspection program personnel (IPP) 

conduct the initial investigation

• The official establishment should also investigate 

and gather information

• Depending on distribution of product or whether 

or not there is associated illness, other participants 

may include:

– USDA Agencies (e.g., Food and Nutrition Service, 

Agricultural Marketing Service)

– Department of Defense

– Food and Drug Administration

– Centers for Disease Control and Prevention

– Department of Homeland Security

Preliminary Investigation

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Food Safety and Inspection Service:

Click to edit Master title style What information should be gathered for a recall?

Product information: 

– Reason for recall;

– Brand names/ Product 

names

– Packaging (Type & Size 

(pounds))

– Package codes (Use by/Sell 

by) and case codes

– Production and Packaging 

dates

– Amount produced (pounds)

– Amount held at 

establishment

– Amount distributed 

(pounds/cases)

– Distribution areas and level

– Photos of label or package

– Count/case

– School lunch (yes/no)

– Department of Defense 

(yes/no)

– Internet or catalog sales 

(yes/no)

Preliminary Investigation

Contact information for the recalling firm:

Establishment number, name, and address

Company Recall Coordinator, Media Contact, Consumer Contact

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Food Safety and Inspection Service:

Click to edit Master title style How does FSIS assess the need for a recall?

• Considerations to determine whether a recall or other action is 

warranted include:

– Hazard assessment

– Regulatory support

– Whether or not product is available in commerce

• FSIS Recall Committee deliberates to determine 

recommendation. Outcomes can include:

– Recall

– Public Health Alert

– Regulatory Action

– No Action

• If analysis supports a recall, the FSIS Recall Committee contacts 

the firm and requests voluntary recall of the product(s)

– Firm representatives may ask questions and discuss any concerns

– Additional information may be considered

Recall Deliberations

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Food Safety and Inspection Service:

Click to edit Master title style Who participates on the FSIS Recall Committee?

Office of Policy and Program 

Development

Provides the statutory basis for 

each recall and addresses other 

statutory issues along with any 

relevant regulations and policies 

Office of Public Health 

Science 

Addresses microbiological, 

epidemiological, and other 

scientific issues associated with a 

recall

Office of Public Affairs and 

Consumer Education 

Generates a Recall Release or 

Recall Notification Report in the 

event of a recall or, when 

appropriate, other notifications 

such as a Public Health Alert

Office of Data Integration 

and Food Protection 

Coordinates the FSIS Emergency 

Management Committee, as 

appropriate

Office of Investigation, 

Enforcement, and Audit

Provides support for detention 

and seizure of product, if 

necessary

Office of Field Operations

Recall Management and Technical Analysis Division – Chairs committee meetings, analyzes and disseminates 

information to other members, and invites other program areas to assist as necessary

District Office – Clarifies information collected during the preliminary inquiry and coordinates field recall 

activities in the event of a recall

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Recall Deliberations
Food Safety and Inspection Service:

Click to edit Master title style How is the recall implemented?

• If the firm agrees to a voluntary recall, FSIS 

issues a recall (press) release

– Firms should issue recall notice to consignees, 

notify public if needed, and provide FSIS with a 

list of retail stores where product was sold

• Recall effectiveness checks are 

implemented

Notifications & Actions

If the firm does not agree to a voluntary recall, FSIS issues a Public 

Health Alert and initiates detention and seizure of product in 

commerce.

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Food Safety and Inspection Service:

Click to edit Master title style What is the Recall (Press) Release? Notifications & Actions

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Food Safety and Inspection Service:

Click to edit Master title style How is the recall release distributed? Notifications & Actions • Public Health Partners – Sent to FSIS, USDA, and other 

Federal, State, and Local 

partners

• Public Notification – Posted on the FSIS Website • Class I: Retail lists posted – Sent to targeted media lists for 

each of the 50 states (unless 

Class III) 

– Tweeted out through the FSIS 

Twitter account

• Translation – Releases are translated into 

Spanish for Web posting and 

distribution

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Food Safety and Inspection Service:

Click to edit Master title style What is a Public Health Alert? Notifications & Actions

• Press release that may be issued if ...

– Meat, poultry, or egg product may be associated with illnesses but 

the Agency cannot identify a specific product to recommend be 

recalled

– Product presents public health risk but is no longer believed to be 

in commerce

– Firm refuses to voluntarily recall product

• Similar to a recall release, alert identifies:

– Firm that produced product

– Describes product involved

– Potential health risk(s)

– Why product adulterated or misbranded

– How consumers should handle the product

– Company contact(s) for consumers and media 15
Food Safety and Inspection Service:

Click to edit Master title style How does FSIS assess recall effectiveness? Notifications & Actions

List 

consignees

Names and addresses for retail 

consignees for a Class I recall 

are posted to the website.

Select 

Locations 

to Perform 

Checks

Number of checks conducted is 

risk-based, dependent on class 

of recall, number of consignees, 

and other factors

Conduct 

checks 

over phone 

or on-site

Product disposition verified at 

subset of total. For Class I, 

checks begin within 3 days and 

substantially complete within 

10 days.

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Food Safety and Inspection Service:

Click to edit Master title style Recall Closure

When is a recall considered closed?

Firm sends FSIS closeout memo with list of 

customers, amount of product retrieved, actions 

taken, and disposition of returned product.

FSIS issues closeout letter to firm and moves 

recall from the Current Recalls and Alerts page on 

the FSIS website to the Recall Case Archive.

Agency reviews lessons learned for improved 

decision-making, increased public health 

protection, and increased consumer confidence.

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Food Safety and Inspection Service:

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Food Safety and Inspection Service

2017 Recall Statistics

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Food Safety and Inspection Service:

Click to edit Master title style 2017 Recall Summary by Classification and Reasons for Recall

Calendar Year 2017 - Reasons for 

Recall (N = 131 recalls)

STECs (8) Extraneous /Foreign Material (24)

Processing Deviation (5) Undeclared Allergen (53)

Undeclared Substance (6) Listeria monocytogenes (15)

Residue (2) Other (17)

Salmonella (1)

Calendar Year 2017 - Recall 

Classification (N = 131 Recalls)

Class I (100) Class II (22) Class III (9)

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Food Safety and Inspection Service:

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Calendar Year Recalls associated with recalled FDA ingredient: 2011 -2017

Calendar Year Pounds Recalled

2011 86,057

2012 99,878

2013 50,733

2014 373,629

2015 242,829

2016 47,470,488

2017 8,497,245

TOTALS 56,820,859

0

2

4

6

8

10

12

14

16

18

20

22

2011 2012 2013 2014 2015 2016 2017

Number of Recalls

Calendar Year 

Salmonella (3)

Listeria

monocytogenes (24)

STECs (2)

Undeclared

Allergens (35)
Food Safety and Inspection Service:

Click to edit Master title style Additional Information

• FSIS Directive 8080.1 Recall of Meat and Poultry Products

• FSIS Directive 8410.1 Detention and Seizure

• FSIS Current Recalls and Alerts website

• FSIS Directive 9900.1 Imported Product Shipment 

Presentation

• Directive 9900.2 Import Reinspection of Meat, Poultry, and 

Egg Products

• How to Develop a Meat and Poultry Product Recall Plan

• AskFSIS

• Small Plant Help Desk or InfoSource@fsis.usda.gov or call 1- 877-FSIS-HELP (1-877-374-7435)

• Industry Support and Resources

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