RECALL INDEX Q3 2017

Transcription

1 RECALL INDEX

2 Recall Index Consumer product recalls dipped 8% to 59 the lowest number since. Recalled units increased 35% to 4.6 million, which is still the second lowest since CONSUMER RECALLS & UNITS MM 120MM 60 90MM MM FLAWED FURNISHINGS 76.2% of recalled units were home furnishings and fixtures, making it the top category. No other category exceeded 9% % of recalled units were due to entrapment/ strangulation or laceration. No other hazard was responsible for more than 6%. 2. Sports/recreational activities & equipment made up the top recall category for the sixth quarter in a row with 23 recalls. No other category had more than Incidents plummeted 92% to 895, the lowest since. Injuries decreased 62.3% to 114, the first quarter with a decline since. TOP CATEGORY BASED ON RECALLS Sports/Recreational Activities & Equipment 39% Home Furnishings & Fixtures 15.3% Personal Use Items 11.9% Toys 10.2% Child Nursery Equipment & Supplies 10.2% AVERAGE FINES PER QUARTER ISSUED BY CPSC $4.7MM $9.3MM AVG. AVG. $7.1MM AVG. AVERAGE REPORTED CONSUMER INJURIES BY QUARTER AVG. AVG. AVG Stericycle, Inc. All rights reserved.

3 Recall Index NHTSA recalls climbed 5% to 197 the second consecutive quarter with fewer than 200 recalls, which last occurred in 2013 and Recalled units rose 76% to 9.5 million. Although an increase, this is still below 4 of the last 6 quarters NHTSA RECALLS & UNITS MM 40MM 30MM 20MM 10MM NHTSA RECALLED UNITS BY PRODUCT TYPE NHTSA RECALL CATEGORIES BASED ON UNITS Airbags ELECTRICAL RECALLS SPARKED Electrical systems made up the second highest category based on units at 17.2%. This is a stark difference from, when it made up just 0.4%. Automobile 64.6% Equipment 31.2% Electrical System 1,635,541 Steering 720,997 4,390, % of NHTSA recalls were equipment. There were 22 more recalls in this category than any other. 2. Automobiles accounted for 64.6% of recalled units, down from 94.9% in. 88.8% of NHTSA recalls were automobiles % of recalled automobile VINs were issued by 4 companies. Visibility Tire 4.2% Service Brakes 651,068 TOP CAUSES OF RECALLED UNITS BY QUARTER Airbags Airbags Seat Belts Seat Belts Airbags Airbags Airbags 3 Stericycle, Inc. All rights reserved.

4 Recall Index Pharmaceutical recalls ticked up 3% to 89 the highest since Recalled units increased 290% more than any quarter since 2012 and the fourth highest since PHARMACEUTICAL RECALLS & UNITS MM 120MM 90MM 30MM TOP PHARMACEUTICAL CAUSES BASED ON RECALLS STERILITY SLIP-UP Powered by one large recall, sterility issues were the top cause of recalled units at 96.7%. 1. Failed specifications accounted for 24.7% of recalls, making it the top cause for the fifth consecutive quarter. 2. There were just 126,838 Class I units recalled, a decline of 98.9% from companies experienced a recall in the highest number since Failed Specs 24.7% Sterility 15.7% % OF PHARMACEUTICAL UNITS BY CLASS Class II 98.9% Class I 0.1% Class III 1% Mislabeling 15.7% Foreign Materials 13.5% 79% OF PHARMACEUTICAL RECALLS WERE NATIONWIDE 4 Stericycle, Inc. All rights reserved.

5 Recall Index Medical Device recalls declined 39% to 167 the lowest quarter since Despite this steep drop, recalled units ticked up 1% to 68 million higher than 16 of the last 19 quarters MED DEVICE RECALLS & UNITS 1 140MM 120MM MM 80MM 40MM 20MM AVERAGE CLASS I UNITS RECALLED PER QUARTER AVG. 276,233 56% UNSTERILE PERIL 89.4% of units were recalled due to sterility issues making it the top cause for the third consecutive quarter. AVG. AVG. 310, ,919 OF MEDICAL DEVICE RECALLS WERE NATIONWIDE 1. The average recall size was 407,256 units higher than any quarter since TOP MEDICAL DEVICE CAUSES BASED ON RECALLS 2. Software was the top recall cause for the sixth quarter in a row % of recalls were distributed both domestically and internationally, the lowest since at least Software Issue 24.6% Quality Issue 17.4% Mislabeling Issue 14.4% Manufacturing Defect 9.6% 5 Stericycle, Inc. All rights reserved.

6 Recall Index FDA food recalls declined 11% to 158 the lowest since. Recalled FDA food units increased 19% to million, higher than 20 of the last 22 quarters. USDA recalls dropped 49% to 24 tied for lowest since Recalled USDA pounds decreased 27% to 7.5 million still higher than 5 of the last 7 quarters. FDA FOOD RECALLS & UNITS 2 2MM MM MM MM MM DIETARY DANGERS 95.6% of recalled FDA units and 97.9% of USDA pounds were considered Class I the most serious classification. 1. Foreign materials accounted for 95.6% of recalled USDA pounds. That s compared to just 6.2% in % of recalled FDA food units were due to undeclared allergens, up from just 8.4% in. 3. Undeclared allergens were also the top cause of FDA food recalls, accounting for 53.8%. That s an increase from 37.1% in. TOP FDA FOOD CATEGORY BASED ON RECALLS TOP FDA FOOD RECALL CAUSES BASED ON UNITS Undeclared Allergens 96.9% Prepared Foods 17.7% Baked Goods 12% Produce 12.7% Supplements 11.4% Bacterial Contamination 2.2% Quality 0.7% Mislabeling 0.2% TOP USDA CATEGORY BASED ON POUNDS Multiple 96.7% Pork 2.0% Poultry 1.1% Beef 0.2% 6 Stericycle, Inc. All rights reserved.

7 Stericycle Expert Solutions & the Recall Index Explained 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. 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 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). 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 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. 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 Stericycle, Inc. All rights reserved.