RECALL INDEX
Q2
2016
Recall Index, Q2 2016
Consumer Products FURNISHINGS IN THE HOT SEAT
Consumer product recalls increased by just 8%, but
that rise represents the second highest number of
recalls since Q1 2011. Recalled units were higher
than any quarter from 2005-2015, despite dropping
74% from the previous quarter.
CONSUMER RECALLS & UNITS
100
150MM
80
120MM
60
90MM
40
60MM
20
30MM
Q2
2014
Q3
2014
Q4
2014
Q1
2015
Q2
2015
TOP HAZARDS BASED
ON RECALLS
Q3
2015
Q4
2015
Q1
2016
Q2
2016
FINES ISSUED BY CPSC
$18.8MM
$23.7MM
Falling
18.6%
82%
of all recalled units were in the home
furnishings & fixtures category.
Fire
2015 Total
18.6%
Fines in Q1 and Q2 2016 have already
reached 126% of all fines in 2015.
CONNECTING THE DOTS
Injury
1. T
here were close to 5,000 reported incidents – nearly
three and a half times higher than Q1. However, injuries
decreased by 22% to 176.
11.6%
Q1/Q2 2016
REPORTED CONSUMER INJURIES
2014
516
2. Nearly 49% of recalls were due to fall, fire, and injury
hazards.
Laceration
10.5%
3. F ull refunds and replacements were the top remedies. 61.6%
of recalls listed at least one of the two.
2015
359
Q1/Q2 2016
401
2
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Recall Index, Q2 2016
Automotive EQUIPMENT RECALLS IN THE FAST LANE
NHTSA recalls rose 40% over the previous quarter,
while recalled units increased 100% to more than 39.6
million, making Q2 the second highest quarter since at
least 2000 for both measurements.
NHTSA RECALLS & UNITS
60MM
50MM
40MM
30MM
20MM
10MM
300
250
200
150
100
50
Q2
2014
Q3
2014
Q4
2014
Q1
2015
Q2
2015
Q3
2015
Q4
2015
Q1
2016
Q2
2016
NHTSA RECALL CATEGORIES
BASED ON VINS
NHTSA PRODUCT
TYPE BY
RECALLED UNITS
Automobile
Airbags
64.1%
89.0%
Equipment
14.2MM
35.9%
recalled units were in the equipment
category, surpassing the previous quarter
to reach their second highest level ever.
Child Seat
<0.1%
Power
Train
2.8%
Tire
<0.1%
CONNECTING THE DOTS
1. Airbags were the top cause of recalled units at 89%.
Seat
Belts
2.3%
Electrical
System
1.2%
Other
4.7%
TOP CAUSES FOR AUTO RECALLS BY QUARTER
2. Five automakers accounted for 82% of recalled automobile
units.
3. Automobile and Equipment recalls accounted for 98.5% of
NHTSA recalls and 99.9% of recalled VINs.
Q3
2014
Q4
2014
Q1
2015
Q2
2015
Q3
2015
Q4
2015
Q1
2016
Q2
2016
Electrical
System
Airbags
Airbags
Airbags
Airbags
Visibility
Airbags
Airbags
3
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Recall Index, Q2 2016
Pharmaceuticals FAILURE LAUNCHED
After a slow start to 2016, pharmaceutical recall
activity went up in Q2, but it was still down from
historical trends dating back to 2004. Recalls rose
35% to their highest level since Q3 2014. Recalled
units increased even more substantially – by 169%.
PHARMACEUTICAL RECALLS & UNITS
100
60MM
75
45MM
50
30MM
25
15MM
Q2
2014
Q3
2014
Q4
2014
Q1
2015
Q2
2015
Q3
2015
Q4
2015
Q1
2016
Q2
2016
# OF COMPANIES WITH >1 PHARMACEUTICAL RECALL
2014
Failed specifications accounted for
68.5% of recalled units in Q2
2015
Q1/Q2 2016
9
13
CONNECTING THE DOTS
14
AVERAGE NUMBER OF
UNITS PER RECALL
1. 66% of recalled units were Class II, resuming a historical
trend after a lower than average Q1, when Class II
accounted for 33% of recalled units.
2014
345,291
2. The average event size in Q2 was nearly 110,000 units,
almost double the average from Q1, but still down from the
historical trend of 150,000.
79%
2015
177,070
Q1/Q2 2016
3. 14 companies experienced more than one recall, the highest
level in a quarter since Q2 2015.
82,549
4
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OF PHARMACEUTICAL
RECALLS WERE
NATIONWIDE
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Recall Index, Q2 2016
Medical Device CLASS CONSISTENCY
In contrast with Q1’s plunge, the number of recalls
increased 38%, making it a tie for highest quarter
since Q3 2014. Recalled medical device units were
three times higher in Q2, but were still 30% lower
than the quarterly average in 2015.
MED DEVICE RECALLS & UNITS
350
100MM
280
80MM
210
60MM
140
40MM
70
20MM
Q2
2014
Q3
2014
Q4
2014
Q1
2015
Q2
2015
Q3
2015
Q4
2015
Q1
2016
Q2
2016
CLASS II UNITS RECALLED
BY QUARTER
Q4 2015
60%
47.1MM
Q1 2016
99%
9.6MM
of recalled units were considered Class II,
continuing a trend that began in Q1 2015.
Q2 2016
40.1MM
CONNECTING THE DOTS
OF MED DEVICE
RECALLS WERE
NATIONWIDE
TOP MED DEVICE RECALL CAUSES BASED ON UNITS
1. The top three causes based on recalls were software,
mislabeling, and quality issues, making up a combined 51%
of recalls.
2. Quality issues, out of specification, and sterility concerns
made up 87.8% of recall reasons based on units.
39.7%
Quality
Issue
3. 49% of med device recalls were international, the lowest
level since Q4 2013.
5
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26.0%
Out of
Specification
22.2%
Sterility
Issue
4.3%
Mislabeling
3.7%
Manufacturing
Defect
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Recall Index, Q2 2016
Food & Beverage CONTAMINATION CONCERNS
Recall activity in the food industry increased across the
board in Q2, with FDA recalls up 82% and USDA recalls
up 12%. Each regulatory body saw one large recall that
caused recalled units to reach new records.
FDA FOOD RECALLS & UNITS
Click here to get more information about food
contamination in our Q2 2016 Recall Industry Spotlight
200
120.0MM
150
90MM
100
60MM
50
30MM
Q2
2014
88.8%
Q3
2014
TOP FDA
FOOD
CATEGORY
BASED ON
UNITS
of USDA recalled pounds were due
to contamination, compared to
13% in 2014 and 23% in 2015.
Q4
2014
Q1
2015
Vegetables
Q2
2015
Q3
2015
Fruit
88.3%
4.1%
Supplements
Baking
Needs
2.5%
2.3%
Q4
2015
Q1
2016
Q2
2016
IMPACT OF A SINGLE
PRODUCE RECALL
Due to a listeria outbreak
2
Countries
Affected
TOP FDA FOOD RECALL
CAUSES BASED ON UNITS
8
CONNECTING THE DOTS
Reported
Illnesses
1. One major recall pushed quality issues to the top cause of
FDA recalls.
2. Undeclared allergen recalls increased 78%, while units rose
225%. Despite this jump, it is only the 4th leading recall
cause based on units.
Quality
92.4%
3. Due to one large recall, USDA recalls involving multiple
proteins accounted for 88% of recalled pounds.
6
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Other
7.6%
42
Brands
Affected
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Stericycle ExpertSOLUTIONS & the Recall Index Explained
Stericycle ExpertSOLUTIONS 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 six product
categories. This helps our partners navigate the regulatory environment and identify trends.
How the Stericycle Recall Index is Compiled
USDA Data
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
Administration (FDA), the Food Safety and Inspection Service (FSIS) of
the United States Department of Agriculture (USDA), and the National
Highway Traffic Safety Administration (NHTSA).
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
FDA 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.
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.
Terminology
Announced recalls represent those recalls documented in news releases
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.
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.
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.
7
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