RECALL INDEX · 2019-04-26 · Medical device recalls decreased 41.4% to 164 - the lowest since Q4...
Transcript of 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
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Recall Index \ Q1 2019
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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.
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Recall Index \ Q1 2019
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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
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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?
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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.
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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?
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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.
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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
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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.
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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?
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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.
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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?
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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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