recall index - stericycle expert solutions€¦ · for additional insight into food recall trends...

RECALL INDEX Q2 2019

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http://stericycleexpertsolutions.com

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3 Introduction

4 Consumer Products

6 Automotive

8 Pharmaceuticals

10 Medical Device

12 Food & Beverage

14 Recall Index Explained

15 Contact Information

TABLE OF CONTENTS

© 2019 Stericycle, Inc. All rights reserved. 2


Recall Index \ Q2 2019


Stericycle Expert Solutions helps partners minimize risk to the public and to their company brand by executing and planning for product recalls efficiently, effectively, and compliantly.

Each quarter, we analyze cumulative recall data across five product categories. This helps our partners navigate the regulatory environment and identify trends.

© 2019 Stericycle, Inc. All rights reserved. 3 StericycleExpertSolutions.com








THEBOTTOM

LINE

Entrapment/strangulation was the top hazard based on units for the first time since Q3 2017, affecting 59% of the recalled units.

The top product category based on recalled units was children's products, making up almost 60% of the recalled units. This is the first time since Q2 2016 that children's products has been the top category.

Incidents increased 457% from Q1 2019 to 919 - lower than 4 of the last 6 quarters. Injuries also increased 458.8% to 95 - higher than 5 of the last 6 quarters.

CONSUMER PRODUCTS






C O N S U M E R R E C A L L S & U N I T S

Consumer product recalls increased 97.4% to 77, which is the highest since Q3 2016. Recalled units increased 425% to almost 9.4 million - higher than 8 of the last 9 quarters. Despite these increases, the average number of recalls per quarter so far in 2019 is down 10.6% from the average in 2017 and 2018. The average number of units is down 69.9% over the same time frame.

Deadly Recalls \ There were 36 deaths due to recalls reported in Q2 2019, 7 more than the previous high since at least 1997. There were 36 deaths in the last 38 quarters combined.

C O N S U M E R I N C I D E N T S & I N J U R I E S

12K

10K

6K

8K

2K

4K

300

250

200

150

100

50

Incidents Injuries

Q12018

Q22018

Q32018

Q42018

Q12019

Q22019

Q32017

Q22017

Q42017

THE STATS

CONSUMER PRODUCTS

135MM

105MM

75MM

45MM

15MM

70

90

50

30

10

Recalls Units

Q12018

Q22018

Q32018

Q42018

Q12019

Q22019

Q32017

Q22017

Q42017

T O P H A Z A R D S B A S E D O N R E C A L L S

T O P P R O D U C T C AT E G O R Y B A S E D

O N R E C A L L S

Sports & Recreation

Home Furnishings & Decor

Apparel

18.2%

9.1%

20.8%

DID YOUKNOW?

Fire

26%

Burn

10.4%Laceration

7.8%

Injury

24.7%






THEBOTTOM

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AUTOMOTIVE

Equipment returns as the top cause for NHTSA recalls at 16%. Equipment has been the top recall cause for 7 of the past 8 quarters.

Automobiles accounted for 93.1% of NHTSA recalls and 98.9% of recalled units. In Q1 2019, automobiles made up just 52.1% of NHTSA recalled units.

The average automobile recall size was 28,867. This is a smaller average than in 7 of the previous 9 quarters.






NHTSA recalls decreased 8.3% to 188 - lower than the past 7 quarters. NHTSA recalled units decreased 77.6% - the third lowest since Q4 2016. The average number of recalls per quarter so far in 2019 is 3.4% down from 2017 and 2018. The average number of units recalled per quarter over that time frame is up 63.6%.

T O P C A U S E S O F R E C A L L E D U N I T S B Y Q U A R T E R

THE STATS

AUTOMOTIVE

27MM

21MM

15MM

9MM

3MM

N H T S A R E C A L L S & U N I T S

200

250

150

100

50

Recalls Units

N H T S A R E C A L L SB Y P R O D U C T T Y P E

N H T S A R E C A L L C AT E G O R I E S B A S E D O N R E C A L L S

Equipment

Service Brakes

ElectricalSystem

FuelSystem

Airbags SeatBelts

Airbags Suspension

Exterior Lighting

Airbags

23

21

18

30

Q12018

Q22018

Q32018

Q42018

Q12019

Q22019

Q32017

Q22017

Q42017 93.1% - Automobile

5.9% - Equipment

1.1% - Tire

Q12018

Q22018

Q32018

Q42018

Q12019

Q22019

Suspension Issues Soar \ Suspension was the top unit recall cause accounting for 24.2% of NHTSA recalled units. This is the first quarter since at least 2000 that suspension was the top cause of recalled units.

DID YOUKNOW?






THEBOTTOM

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PHARMACEUTICALS

cGMP deviation was the top reason for pharmaceutical recalls for the first time since at least Q1 2016.

cGMP deviation was also the top reason for pharmaceutical recalled units. This has been the top cause for 4 of the last 5 quarters.

The average size of a recall was 311,560 - higher than 11 of the previous 15 quarters






Pharmaceutical recalls decreased 18.1% to 77 - tied for the second lowest over the past 10 quarters. Recalled units increased 86.3% to just under 24 million - almost double the amount of recalled units in Q1 2019. The average number of recalls per quarter so far in 2019 is down 9.0% from the average in 2018. The average number of recalled units per quarter is down 76.0% from the average in 2017 and 2018.

T O P P H A R M A C E U T I C A L C A U S E S B A S E D O N R E C A L L S

THE STATS

PHARMACEUTICALS

300MM

350MM

250MM

150MM

200MM

100MM

50MM

P H A R M A C E U T I C A L R E C A L L S & U N I T S

80

100

120

140

60

40

20

Recalls Units

% O F P H A R M A C E U T I C A L U N I T S B Y C L A S S

O F P H A R M A C E U T I C A L R E C A L L S W E R E

N AT I O N W I D E

14.3% - Class I

66.2% - Class II

18.2% - Class III

1.3% - Unclassified

79.2%

cGMPDeviations

22.1%Mislabeling

15.6%Sterility

13%

FailedSpecifications

19.5%

ForeignMaterial

10.4%

Manufacturing Woes Continue \ There were just under 23 million Class II units recalled this quarter. This is higher than 13 of the previous 15 quarters.

DID YOUKNOW?

Q12018

Q22018

Q32018

Q42018

Q12019

Q22019

Q32017

Q22017

Q42017






THEBOTTOM

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MEDICAL DEVICE

The average recall size was 98,662 - the lowest quarter since Q1 2017.

At 52.3%, quality issues were the top cause based on units for the second consecutive quarter. Prior to Q1 2019, the last time quality issues were the top cause was Q3 2016.

56% of the recalls were of products distributed domestically and internationally. This is the highest percentage since Q1 2016.






Medical device recalls increased 22% to 200 - lower than 9 of the previous 12 quarters. Recalled units decreased 85.4% to 19.7 million - the lowest since Q1 2017. The average number of recalls per quarter in 2019 is down 32.1% from the average quarter in 2017 and 2018. The average number of units per quarter in 2019 is down 29.9% from the average in 2018.

T O P M E D I C A L D E V I C E C A U S E S B A S E D O N R E C A L L S

THE STATS

MEDICAL DEVICE

200MM

160MM

120MM

80MM

40MM

M E D I C A L D E V I C E R E C A L L S & U N I T S

400

500

300

200

100

Recalls Units

Q12018

Q22018

Q32018

Q42018

Q12019

Q22019

Q32017

Q22017

Q42017

U N I T S R E C A L L E DB Y C L A S S

O F M E D I C A L D E V I C E R E C A L L S W E R E

N AT I O N W I D E

69%

Software Issue

49Quality Issue

31

Outside ofSpecifications

18

MislabelingIssue

32

Class I

Class II

Class III

12,839,049

17,782

6,875,621

Quality Control \ There were 12.8 million Class II units recalled this quarter, less than 19 of the previous 21 quarters.

DID YOUKNOW?






THEBOTTOM

LINE

FOOD & BEVERAGE

20.5% of the FDA food recalls were of products that had been distributed nationwide. This is the highest since Q1 2016.

For the eighth consecutive quarter, undeclared allergens was the top cause of FDA food recalls at 48.4%.

Undeclared allergens were the top cause of recalled USDA pounds at 62.9%. The most common undeclared allergen, milk, was found in 99.7% of the undeclared allergen recalled pounds.






FDA food recalls increased 23.2% to 122 - the second lowest quarter since Q1 2016. Recalled FDA food units decreased 97.3% to 2 million - the lowest in 12 quarters. USDA recalls decreased 17.9% to 32 - still higher than 5 of the last 7 quarters. Recalled USDA pounds increased 133.7% to 3.3 million - higher than 5 of the previous 6 quarters. For FDA food, the average quarter in 2019 is down 29.6% in recalls and 43.2% in recalled units from the average quarter in 2017 and 2018.

T O P U S D A C AT E G O R I E S B A S E D O N R E C A L L S

THE STATS

FOOD & BEVERAGE

250MM

200MM

150MM

100MM

50MM

F D A F O O D R E C A L L S & U N I T S

200

250

150

100

50

Recalls Units

T O P U S D A R E A S O N S B A S E D O N R E C A L L S

T O P F D A F O O D C AT E G O R I E S B A S E D O N

R E C A L L S

Foreign Material

No Inspection

Poultry

28.1%Multiple

25%Pork

15.6%Seafood

9.4%Beef

21.9%

Undeclared Allergen

28.1%

21.9%

31.3%

Q12018

Q22018

Q32018

Q42018

Q12019

Q22019

Q32017

Q22017

Q42017

1 2 3 4 5

Prepared Foods

25

Supplements

14Baked Goods

11

Produce

18

Keep It Clean \ Foreign material was the top cause for FDA recalled units at 1 million units. This is only the second time foreign material has been the top cause for FDA recalled units since Q1 2016.

DID YOUKNOW?






HOW THE STERICYCLE RECALL INDEX IS COMPILED

The Stericycle Recall Index gathers and tracks cumulative data from the four primary federal agencies that oversee recalls in the United States: the Consumer Product Safety Commission (CPSC), the Food and Drug Admin-istration (FDA), the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA), and the National Highway Traffic Safety Administration (NHTSA).

FDA DATA

To track trends in food, pharmaceutical, and medical device recalls, the Stericycle Recall Index uses information publicly available in news releases posted on the FDA website. For additional insight into recalls governed by the FDA, Stericycle collects and analyzes data from the agency’s weekly enforcement reports, which provide additional details including recall class, quantity of units affected, and number of reported incidents.

CPSC DATA

For further insight into consumer product recall trends, Stericycle analyzes data from CPSC recall announcements. When compiling statistics and analyzing trends for consumer product recalls, the Stericycle Recall Index uses standard product categories and hazards recognized by the CPSC.

USDA DATA

For additional insight into food recall trends involving meat, poultry, and egg products, the Stericycle Recall Index collects and analyzes data from recall announcements posted on the USDA’s FSIS website. Statistics and trends are compiled using standard product categories, classifications, and reasons for recalls as recognized by the USDA.

NHTSA DATA

To understand trends in the automotive industry, the Stericycle Recall Index analyzes data from NHTSA reports on recalls of autos, child seats, equipment, and tires.

TERMINOLOGY

Announced recalls represent those recalls documented in news releas-es published on agency websites. Enforced recalls refer to those recalls documented in weekly FDA enforcement reports that are summarized based on the FDA assigned Event ID. Their documentation can lag behind announced recalls by weeks or even months because the recall process may take time to complete.

RECALL INDEX EXPLAINED

A Class I recall, according to the FDA, is a situation in which there is a reasonable probability that the product will cause serious adverse health consequences or death. A Class II recall is a situation in which the product could cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. The FDA defines a Class III recall as a situation in which the product is not likely to cause adverse health consequences.




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recall index - stericycle expert solutions€¦ · for additional insight into food recall trends...

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