recall index · 2019-04-26 · medical device recalls decreased 41.4% to 164 - the lowest since q4...

RECALL INDEX Q1 2019

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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 \ Q1 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

Fire was the top hazard based on units and recalls for the second consecutive quarter. Fire has been the top hazard for both in four of the last five quarters.

The top product category based on recalled units was electronics, making up more than a quarter of the recalled units. This is the first time since Q2 2017 that electronics has been the top category.

Incidents decreased 94% from Q4 2018 to 165 - the lowest quarter since at least 1997. Injuries decreased 77.3% to 17 - the second lowest since at least 1997.

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 decreased 43.5% to 39. Recalled units decreased 67.3% to almost 1.8 million. Both of these totals are the lowest quarter since at least 1997.

Recalls Slow Down \ The average recall size was 45,786 - the lowest since Q4 2012 and the sixth lowest since at least 1997.

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

20K

15K

10K

5K

300

225

150

75

Incidents Injuries

Q42017

Q12018

Q22018

Q32018

Q42018

Q12019

Q22017

Q12017

Q32017

THE STATS

CONSUMER PRODUCTS

135MM

105MM

75MM

45MM

15MM

70

90

50

30

10

Recalls Units

Q42017

Q12018

Q22018

Q32018

Q42018

Q12019

Q22017

Q12017

Q32017

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

Power Supplies

Home Furnishings & Decor

53.8% - Refund

26.3% - Repair

19.3% - Replacement

0.6% - Other

15.4%

15.4%

25.6%

DID YOUKNOW?






THEBOTTOM

LINE

AUTOMOTIVE

Airbags and service brakes tied for the top cause for NHTSA recalls at 12.2% each. This breaks a 7 quarter streak for equipment.

Automobiles accounted for 91.7% of NHTSA recalls and 52.1% of recalled units. In Q4 2018, automobiles made up 94% of NHTSA recalled units.

78.4% of automobile recalled VINs were issued by just five companies.






NHTSA recalls decreased 6.8% to 205 - higher than 4 of the last 7 quarters. NHTSA recalled units increased 387.4% to just over 24 million - the highest since Q2 2016.

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

Airbags

Service Brakes

Equipment ElectricalSystem

FuelSystem

Airbags SeatBelts

Airbags

Equipment

Exterior Lighting

25

24

17

25

Q42017

Q12018

Q22018

Q32018

Q42018

Q12019

Q22017

Q12017

Q32017 91.7% - Automobile

7.8% - Equipment

0.5% - Tire

Q42017

Q12018

Q22018

Q32018

Q42018

Q12019

Airbag Headaches Continue \ Airbags were the recall category for 73.6% of the NHTSA recalled units. The last time any category made up that high of a percentage was Q1 2017, when 74.1% of the recalled units were airbags.

DID YOUKNOW?






THEBOTTOM

LINE

PHARMACEUTICALS

For the eleventh consecutive quarter, failed specifications were the top reason for pharmaceutical recalls.

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

4 companies reported at least 5 recalls each in the quarter - the highest number since Q3 2013.






Pharmaceutical recalls decreased 7.8% to 94 - higher than 19 of the last 21 quarters. Recalled units decreased 75.3% to just under 13 million - lower than 6 of the last 9 quarters.

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

10% - Class I

82% - Class II

8% - Class III

77.7%

Failed Specs

26.6%Mislabeling

14.9%Sterility

8.5%

cGMPDeviations

22.3%

ForeignMaterial

6.4%

Manufacturing Woes Impact Drug Recalls \ There were more than 1 million Class I units recalled for the second consecutive quarter. The last time there were two consecutive quarters with at least 1 million units each was Q2 and Q3 2015.

DID YOUKNOW?

Q42017

Q12018

Q22018

Q32018

Q42018

Q12019

Q22017

Q12017

Q32017






THEBOTTOM

LINE

MEDICAL DEVICE

The average recall size was 823,126 - the highest quarter since 2006.

At 51.2%, quality issues were the top cause based on units, mostly due to one large recall. This is the first time quality issues were the top cause since Q3 2016.

No company reported ten or more recalls in the quarter for the first time since Q3 2017.






Medical device recalls decreased 41.4% to 164 - the lowest since Q4 2017 and second lowest since Q4 2011. Recalled units decreased 16.2% to just under 135 million - the third highest since at least 2005.

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

Q42017

Q12018

Q22018

Q32018

Q42018

Q12019

Q22017

Q12017

Q32017

C L A S S I U N I T S R E C A L L E D P E R Q U A R T E R

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

55.5%

Software Issue

37Quality Issue

21Sterility

15

MislabelingIssue

31

Q3 2018

Q4 2018

Q1 2019

1,380,706

1,388,655

14,035,195

Medical Device Maladies \ There were more than 1 million Class I units recalled for the third consecutive quarter. The last time there were three consecutive quarters with at least 1 million units each was Q2 to Q4 2014.

DID YOUKNOW?






THEBOTTOM

LINE

FOOD & BEVERAGE

17.2% of the FDA food recalls were of products that had been distributed nationwide. This is the second highest since Q4 2016.

For the second consecutive quarter, undeclared allergens were the top cause of both FDA food recalls at 38.4% and recalled FDA food units at 98.1%.

Foreign materials were the top cause of recalled USDA pounds at 37.9%. The most common foreign material, plastic, was found in 40% of the foreign material recalled pounds.






FDA food recalls decreased 36.5% to 99 - the second lowest quarter since Q3 2015 and third lowest since at least 2010. Recalled FDA food units increased 67.2% to 79 million - higher than four of the previous five quarters. USDA recalls decreased 7.1% to 39 - higher than 12 of the last 14 quarters. Recalled USDA pounds decreased 91.6% to just over 1.4 million - higher than 3 of the previous 5 quarters.

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

Undeclared Allergen

Foreign Material

Poultry

41%Pork

23.1%Beef

10.3%Multiple

10.3%Seafood

15.4%

No inspection

30.8%

17.9%

30.8%

Q42017

Q12018

Q22018

Q32018

Q42018

Q12019

Q22017

Q12017

Q32017

1 2 3 4 5

Prepared Foods

24

Baked Goods

11Dairy

9

Produce

12

Look Before You Cook \ Due to one large recall, the top product category for recalled FDA food units was prepared foods at 98.1%. That one large recall accounted for 95.8% of all recalled FDA food units.

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 · 2019-04-26 · medical device recalls decreased 41.4% to 164 - the lowest since q4...

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