Sedgwick Brand Protection
The world’s leading product recall company
Protecting brands and peace of mind since 1995.
SEDGWICK BRAND PROTECTION
The world’s leading product recall company
For over 25 years, companies of all sizes and sectors have trusted our expertise in preparing for and managing their product-related challenges. Since 1995, we』ve successfully managed more than 7,000 of the most sensitive and time-critical product recall programs, spanning 100 countries and 50 languages.
Whether your in-house teams need scalability to maintain daily operations during a product crisis, or you require a complete end-to-end product recall solution, we have the experience to protect your brand and peace of mind.
If you’re currently facing a product recall, or seeking to enhance your recall readiness, contact us now.
OUR SOLUTIONS
When your reputation is on the line, we put our 25+ years of experience on 7,000+ global recall events to work for you. From recall-readiness audits and mock recall simulations, to complete turn-key retrieval and remediation solutions – including regulatory guidance and reporting, we have the experience and resources to help manage your product wherever it is in market.
Every day, we help companies of all sizes and industries safeguard their customers, their brands, and their bottom-lines. Discover how Sedgwick Brand Protection can help you.
Product Recall
The notification, retrieval, processing, storage, disposal and regulatory reporting of recalled products are complex undertakings. We help companies manage recalls in a way that upholds their commitments to customers, supply chain partners and regulators.
Remediation
While they may not be subject to recall, defective, damaged or out of specification products can cause significant financial/reputational damage. Discover how we locate, withdraw, replace, repurpose and recycle violative (non-recalled) products in market.
Customer Retention
When defective products compromise consumer safety, people want more than answers. They want to feel heard, on their terms. Effective communication has never been as important as it is today, especially in time-critical/complex product recall situations.
TRUSTED BY THE WORLD』S LEADING BRANDS AND BUSINESSES
Sedgwick brand protection is the world’s leading product recall provider. Since 1995, we』ve managed 7,000+ of the most sensitive recall events, spanning 100+ countries and 50+ languages.
25+
Years of experience
7,000+
Product recall events
100+
Countries
50+
Languages
ACROSS INDUSTRY
For over 25 years we』ve partnered with the world’s leading brands and businesses across industry to help them manage the risks, minimize the impacts, and mitigate the future onset of product recalls and other in-market product crises.
During this time our goal has remained consistent; to helps brands uphold their promises of safety, quality, and service to their customers, supply chain partners, and industry regulators.
Automotive
The industry’s drive to electrification signifies a crucial step towards sustainability but ushers in a new era of product safety. EVs necessitate new regulatory norms, safeguards for battery technology and cybersecurity. With this comes significant risk.
Food & Drink
The sector faces a myriad of challenges, from supply chain constraints, to sustainability and transparency demands. Recent rises in pathogenic bacteria, undeclared allergens and foreign materials underscores the need for rigorous QC and recall planning.
Retail & Consumer
Supply chain management is inherently complex, involving manufacturers, suppliers, retailers and regulators. This is reflected by consumer product recalls, which have soared to a 10-year high. Mishandling these events can lead to devastating consequences.
Medical Device
Technological advancements, the growing influence of digital health, mounting supply chain pressures, enhanced pathogen identification, and heightened regulatory scrutiny, have contributed to a 6.5% growth in medical device recalls over the past 5 years.
Pharmaceutical
Recent surges in cGMP deviations (+84%), contamination (+82%) and sterility issues (+60%) have driven a 17.1% Y-o-Y rise in global drug recalls. Increasingly complex supply chains and heightened regulatory scrutiny, necessitate meticulous recall planning.
Technology
The convergence of AI and machine learning marks a new era of regulatory scrutiny. While advanced automation and data analytics improve product quality and traceability, the increasing dependence on these technologies has escalated the gravity of recalls.
ESSENTIAL INSIGHT
The spotlight on product safety is shining brighter than ever. From new voluntary standards and official rulemaking to unilateral warnings from regulators, companies across all industries and jurisdictions face unprecedented threats. Gain unrivalled perspective on the latest product safety regulation and what this means for you.
For over a decade, Sedgwick brand protection has published its quarterly Recall Index report. Downloaded in more than 100 countries, the Index has established itself as the definitive guide to product safety. Access high-level insights below and download our latest edition in full.
QUARTER 3, 2023 – KEY PRODUCT SAFETY INSIGHTS
Food & Drink
United States:
The total number of FDA food recalls fell by 14.4% in Q3 2023 compared to the previous quarter. The number of units decreased even more, falling from 114.06 million units in Q2 to 40.20 million in Q3, a decline of 64.8%. There were 121 unique companies who had product recalls in Q3 2023.
There were 52 recalls for undeclared allergens, making it the leading cause of U.S. food recalls for all but one quarter since Q2 2017. There were six recalls involving undeclared sesame, which affected 12,985 units. Bacterial contamination was a distant second in terms of events with 24 recalls in Q3. It also had the second-highest number of units recalled with 7.97 million. Units outside of specifications accounted for the most units impacted with 14.95 million units.
Prepared foods was the top recall product category in Q3 in terms of events with 31 recalls. Produce was the second-highest category with 25, and dairy was third with 16. In terms of units impacted, beverages had the most with 15.04 million units. Dairy was second with 11.08 million units affected, and flavorings was third with 7.14 units involved in recalls.
Europe:
Regulators in the EU and UK reported 1,194 food and beverage recalls in Q3 2023, up 1.1% compared to Q2 2023. The leading cause of recalls this quarter was contamination—other, with 470 events. The most common contaminants of concern were aflatoxins and chlorpyrifos, which were linked to 79 and 59 recalls respectively this quarter. The second leading concern across the food and beverage sector was bacterial contamination which was cited in 266 recalls. Salmonella was the most common bacterial risk and was tied to 182 recalls.
Fruits and vegetables remained the product category with the most recalls with 192 events in Q3 2023, down slightly from 206 last quarter. Nuts, nut products, and seeds was the second-most impacted category with 127 recalls, slightly higher than the 122 recalls last quarter. Poultry meat and poultry meat products was the third-highest product category with 122 events, up by 69.4% compared to Q2 2023.
In terms of notifications, the Netherlands recorded the most with 156. Germany was second with 146, the same number it had in Q2. Italy was third with 105 notifications. The UK submitted 29 notifications in Q3 2023, the same number it had in Q2 2023.
Consumer Product
United States:
Both the number of recalls and the number of units recalled by the CPSC were lower in Q3 2023 compared to Q2 2023. There were 65 consumer product recalls compared to 76 events last quarter, a 14.5% drop. The change in units impacted was more significant, falling by 58.0% from 20.65 million last quarter to only 8.67 million in Q3. The average recall size was also lower, decreasing from 271,767 in Q2 to 133,308 units in Q3. Regulators issued $20.5 million in fines in Q3 2023.
Fire was the top consumer product hazard by event in Q3 2023, tied to 19 recalls. Lacerations was the second-leading concern with eight events, followed by injury and crash which each recorded seven recalls. Lacerations was also the top risk by volume with 2.42 million units affected, followed closely by fire with 2.41 million units impacted.
Sports & Recreation accounted for the most recalls by product category, linked to 17 events in Q3 2023. Yard and Garden was second with 11 recalls, and Children’s Products was third with seven events. In terms of units impacted, Home Furnishings was the top product category with 2.51 million units recalled, or 29.0% of all units in Q3. Home Appliances was second with 1.64 million units affected, followed by Sports & Recreation with 1.09 million units.
Europe:
There were 110 electronics recalls across the EU and UK in Q3 2023, down 34.5% from Q2 2023. It is worth noting that the 168 recalls last quarter represented the most in this sector in more than 10 years, so it is not surprising that the total this quarter is lower.
There were 103 toy recalls across the UK and EU in Q3 2023, a 14.2% drop from the 120 events recorded in Q2 2023. Choking was the most common reason for toy recalls in Q3 with 36 events. When combined with other risks such as injuries and suffocation, the total rises to 44. Chemicals as a standalone cause was the second most-cited concern for Q3 with 24 recalls, though when other causes such as choking or injuries are added, the total rises to 28.
There were 59 clothing recalls in Q3 2023 in the UK and EU, representing a 49.6% drop from Q2 2023. Last quarter was the only quarter since Q4 2017 to exceed 100 recalls. Lower figures in Q3 are not unusual. The five-year average for third quarter recall is 43 events.
Automotive
United States:
NHTSA issued 197 automotive recalls in Q3 2023, a 15.8% decrease compared to the previous quarter. The number of impacted units was also lower, going from 8.21 million in Q2 2023 to 7.92 million in Q3.
Electrical systems was the leading cause cited for NHTSA recalls again in Q3, linked to 41 events. Equipment and power trains tied for the second-most recalls with 20 events each. Hydraulic service brakes were only linked to five recalls but impacted 3.41 million units, more than any other category. Back-over prevention equipment affected 1.28 million units across 13 recalls in Q3, making it the second-highest category by volume.
Automobiles was the largest product category of recalls with 176 events in Q3 2023, down from 214 last quarter. The equipment category had 20 recalls that impacted 317,530 units. There was one recall for tires and no recalls for child seats in Q3 2023.
Europe:
There was a 1.4% increase in automotive recalls across the UK and Europe from Q2 2023 to Q3 2023, with the number of events increasing from 214 to 217. This is only the third quarter in more than 10 years that saw more than 200 automotive recalls and the second-highest quarter for events in that same period.
There were 164 recalls tied to injuries in Q3 2023, reflecting a 12.3% increase from the 146 reported in the previous quarter. Fire risk was the second-most common cause for recalls, linked to 38 events as a single concern but rising to 44 recalls if other factors such as injuries and environment are included. Passenger cars was the most common product category recalled in Q3 2023 with 147 events. Motorcycles was the second-most-recalled product category with 15 events, followed by lorries with 10 recalls.
The UK remained the country with the most recall alerts for the seventh consecutive quarter with 96 notifications in Q3 2023. Germany issued the second-highest number of alerts with 68, down from 74 notifications last quarter. France submitted 36 alerts in Q3 2023, up slightly from the 31 it had in Q2.
Medical Device
United States:
The number of medical device recalls decreased by 7.9%, with 222 events in Q3 2023 compared to 241 recalls in Q2 2023. The number of impacted units dropped by 63.1% to 24.48 million this quarter. Quality issues were the leading reason for recalls in the sector, accounting for 49 events in Q3 2023. Mislabeling concerns were the second-most common cause with 29 events, followed by safety with 24 recalls.
In terms of impacted units, parts issues was the top reason for recalls in Q3 2023, affecting 7.62 million devices, including two separate recalls for probe covers that impacted 5.61 million and 1.51 million units, respectively. Sterility issues affected the second-highest number of medical device units with 5.19 million in Q3 2023. Concerns about false results affected 2.77 million units, followed closely by quality issues which impacted 2.76 million units.
The number of recalls across all Class designations of medical devices fell from Q2 to Q3 2023, as did the number of units recalled in each category. The number of units involved in Class I events fell from 15.74 million in Q2 to 649,124 in Q3 across 19 events. The volume attributed to Class II recalls decreased by 52.9% quarter-over-quarter. Even more significant was the drop in Class III units, which fell by 97.0% to 1,112 units in Q3 compared to 37,574 units last quarter.
Europe:
Across the UK and EU, there were a total of 886 medical device recalls in Q3 2023. This is an increase of 17.2% compared to Q2 2023. It is also the highest quarterly total since Q1 2021.
Software was the most common reason for Q3 2023 medical device recalls with 114 events, a 14.0% increase from Q2 2023. Safety concerns was the second-most cited issue, accounting for 106 recalls. There were 82 recalls for device failure, making it the third-most common cause of recalls this quarter, though it also marks a significant drop from the 102 device failure recalls in Q2.
In Q3 2023, Germany issued the most recall notifications for medical devices with 199, the same number it had in Q2 2023. France also had the same number of recalls as it did last quarter, holding its position as the second-highest issuer with 197 notifications. Italy was third with 169 notifications, on par with its 166 alerts last quarter.
Pharmaceutical
United States:
The number of pharmaceutical recalls in Q3 2023 dropped by 20.7% from Q2 2023 to 107 events. The number of units recalled decreased even more, going from 24.24 million units in Q2 to 7.42 million in Q3, representing a decline of 69.4%. Sterility was the leading cause of pharmaceutical recalls with 45 events, or 42.1% of total recalls. Sterility also had the most units recalled in Q3, with 4.10 million, or 55.2% of recalled units. There was only one recall in Q3 that impacted more than 1.00 million units.
Failed specifications were the second-most common cause for pharmaceutical recalls in Q3 2023, linked to 16 events. This concern was also tied to the second-highest number of units recalled with 1.50 million. cGMP deviations were third in terms of events with 13 recalls.
Both the number of recalls and the units impacted rose for Class I recalls. While the number of events only increased from seven to eight, the number of units impacted grew from 21,099 in Q2 to 692,869 in Q3. The number of recalls and units for Classes II and III were lower, with Class II units falling from 23.09 million in Q2 to 6.28 million in Q3.
Europe:
Pharmaceutical recalls across the EU and UK increased by 48.6% in Q3 2023 compared to Q2 2023. There were 110 events this quarter compared to 74 in the previous quarter.
Safety risks was the leading cause of pharmaceutical recalls and was linked to 22 events this quarter, down slightly from 30 events in Q2 2023. The second-most common concern was foreign materials/contamination with 19 events, followed by mislabelling with 15 events in Q3. Last quarter, only eight recalls were attributed to foreign materials/contamination, and five were tied to mislabelling.
Germany had the most notifications, issuing 22 alerts in Q3 2023, up from 10 last quarter. France was second with 20 notifications and the UK was third with 19. Portugal followed with 15 notifications in Q3.
QUARTER 2, 2023 – KEY PRODUCT SAFETY INSIGHTS
Food & Drink
United States:
In Q2 2023, the number of food and drink product recalls rose by 30.8% to 153. The increase in the number of units impacted was even more dramatic with 114.1 million units affected, representing a 190.6% increase from Q1.
There were 82 product recalls attributed to undeclared allergens, an uplift of 46.4% on the 56 events reported in Q1. Undeclared allergens were also responsible for the most units recalled this quarter, a total of 85.0 million, accounting for 74.5%.
Prepared foods was the top recall category both in terms of events and units impacted, there were 42 product recalls involving 61 million units.
Europe:
Regulators in the EU and UK reported 1,181 food and drink product recalls in Q2 2023. The leading cause of recalls this quarter was 「Contamination – Other」 with 456 events, or 38.6% of all product recalls. The second leading concern was bacterial contamination, cited in 239 recalls. Of this concern, Salmonella was the most common risk with 160 product recalls, followed by Listeria with 39.
Fruits and vegetables was the product category with the most recalls with 206 events, followed by nuts, nut products, and seeds in second with 126. Germany had the most with 146. Belgium was second with 126 and the Netherlands was third with 105 notifications.
Consumer Product
United States:
There were 76 consumer product recalls in Q2 2023 compared to 94 in the previous quarter, representing a 19.1% drop. The sector also experienced a 10.7% reduction in the number of units impacted, with 20.7 million.
Fire was the leading consumer product hazard by event with 14 recalls, followed by burns with 11 and injury with 10. Laceration was the top risk by unit with 13.1 million units across nine events. Sports & Recreation accounted for the most product recalls by product category, linked to 21 events.
In terms of units impacted, Toys were the top product category with 7.6 million units recalled, or 36.6% of all units in Q2 2023. Home Furnishings was second with 5.5 million units.
Europe:
There were 168 European consumer electronic product recalls in Q2 2023, the highest number for the sector in more than 10 years. The most common risk was electric shock, which was linked to 73 product recalls. Lighting chains were the most recalled product, cited in 27 events.
There were 120 toy product recalls across Europe in Q2 2023, a 19.5% drop from Q1 2023. Chemical risk was the most common cause for toy recalls with 49 events. There were 28 recalls for plastic dolls, making it the most common type of toy recalled. In second place was soft toys with 15 events.
There were 117 European clothing product recalls in Q2 2023, marking the highest quarterly figure in the past five years. A variety of children’s apparel held the top three spots for the most recalled items: there were 31 events for hoodies, 13 for trousers, and 11 for sweatshirts.
Automotive
United States:
NHTSA issued 234 automotive product recalls in Q2 2023, a decrease of 4.5% compared to Q1 2023. The number of recalled units increased slightly, from 7.6 million in Q1 2023 to 8.2 million in Q2 2023.
Electrical systems were the leading cause cited for NHTSA product recalls, linked to 51 events compared to 48 last quarter. Back-over prevention was responsible for the most units recalled with 1.7 million, though there were only six product recalls for this concern. Air bags were second with 1.3 million units, but only accounting for five product recall events.
Automobiles were the largest product category of recalls with 214 events in Q2 2023, down two events compared to last quarter. The equipment category had 18 recalls that impacted 179,350 units. Child seats and tires had one recall each.
Europe:
There was a 12.6% increase in automotive product recalls across the EU and UK from 190 in Q1 2023 to 214 in Q2 2023. At the halfway point of this year, European automotive recall activity was at its highest level in more than ten years with 404 events.
There were 146 product recalls tied to injuries in Q2 2023, reflecting a slight decrease from the 152 reported in Q1. Fire risk was the second-most common cause for recalls, linked to 43 events as a single concern, but rising to 59 recalls if other factors are included.
In Q2 2023, the UK remained the country with the most product recall alerts with 93, a slight increase compared to the 83 alerts in Q1 2023. Germany issued the second-highest number of recall alerts with 74, up from the 63 notifications last quarter. France submitted 31 recall alerts in Q2 2023.
Medical Device
United States:
The number of medical device product recalls decreased to 241 events in Q2 2023 from 252 recalls in Q1 2023. Looking at H1 as a whole, the 493 recall events recorded in H1 2023 are up 10.3% on the 447 recorded in H1 of 2022.
Quality issues were the leading reason for product recalls in the sector, accounting for 38 events. Parts issues were the second-most common concern with 27 events, followed by software, and mislabeling which both recorded 20. In terms of units impacted, sterility concerns led to the recall of 21.1 million medical devices in Q2 2023.
The number of Class I medical device product recalls increased 71.4% to 24 events in Q2 2023, which represents the highest quarterly figure for Class I designations in over ten years.
Europe:
There were a total of 756 medical device product recalls across Europe in Q2 2023. This is down slightly from 790 events in the previous quarter. Despite this decline, at the halfway point of the year, product recall activity is up 13.0% from H1 2022.
Device failure was the most common reason for product recall in Q2 2023 with 102 events. Software concerns were the second-most cited issue, accounting for 100 events. The number of product recalls linked to medical device safety fell by 21.6% to 76 in Q2 2023.
Germany issued the most recall notifications with 199, a 6.4% increase from Q1 2023. France was the second top issuer with 197 notifications, followed by Italy with 166 recall events.
Pharmaceutical
United States:
The number of pharmaceutical product recalls fell 6.3% from 144 in Q1 2023 to 135 in Q2 2023. This does not include any of the 85 voluntary recalls issued by a manufacturer that filed Chapter 7 bankruptcy in February 2023. The FDA has yet to report any unit numbers for these recall events.
There were 24.2 million pharmaceutical units recalled in Q2 2023, a 51.1% decrease from last quarter. The average product recall size also fell to 179,587 in Q2 2023. That is the second-lowest total since Q1 2019.
Sterility was the leading cause of pharmaceutical product recalls with 54 events, or 40.0% of total activity. Sterility also accounted for the most units recalled in Q2, with 18.7 million, or 76.9%. cGMP deviations were the second-most common cause for pharmaceutical recalls with 24 events.
Europe:
Pharmaceutical product recalls across the EU and UK dropped by 14.0% from 86 in Q1 2023 to 74 events in Q2 2023. Despite this decline, at the halfway point of 2023, European pharmaceutical product recall activity is up 8.8% from 147 in H1 2022 to 160 events in H1 2023.
Accounting for 30 events, safety risks were the leading cause of pharmaceutical product recalls in Q2 2023. The second-most common concern was quality with nine events, followed by foreign materials / contamination with eight. France was responsible for the most recall notifications, issuing 19 in Q2 2023, followed by Spain and Germany with 10 each, and then the UK with eight.
QUARTER 1, 2023 – KEY PRODUCT SAFETY INSIGHTS
Food & Drink
United States:
FDA food product recalls increased by 23.2% to 117 in Q1 2023. However, the number of units impacted plummeted 78.7% compared to last quarter, from 184.0 million to 39.3 million. A major recall for a workout beverage contaminated with plastic was responsible for 21.0 million units.
Undeclared allergens was the leading cause of U.S. food recalls, with 56 events, while Foreign materials impacted the most units, with 29.7 million units.
The number of Class I product recall events fell from 34 to 29 in Q1, and involved 3.3 million units. Class II recalls increased from 55 last quarter to 67 (impacting 33.7 million units), while Class III recalls rose from six to 21 recalls (impacting 2.2 million units).
Europe:
Regulators in the EU and UK reported 1,154 food and drink product recalls in Q1 2023, up 2.9% compared to Q4 2022. The leading cause was 『Contamination – Other』 with 486 events. The most common contaminant of concern was aflatoxins, linked to 89 product recalls.
Regulators are recalling food products containing cannabidiol (CBD). In Q3 2022, there were nine food recalls involving CBD. In Q4 2022, that number rose to 11, and this quarter there were 24, mostly classifying it as an unauthorised novel food.
Fruits and vegetables remained the product category with the most recalls, totalling 187 events in Q1 2023, a 12.0% rise from the previous quarter. Nuts, nut products, and seeds were the second-most impacted with 126 product recalls.
Consumer Product
United States:
There were 94 consumer product recalls in Q1 2023, the most recalls in a single quarter since Q3 2015. The total number of units recalled increased 442.1% from the previous quarter to 23.1 million, making it the highest quarter by recalled units since Q4 2017.
Burns were the top consumer product hazard by event, with 23 recalls. Hazardous materials were the top risk by unit with 6.9 million units, while Children’s Products accounted for the most product recalls by category, making up 28.7% of recalls with 27 events.
In terms of units impacted, Children’s Products was also the top product category with 6.3 million units recalled. Kitchen products was second with 5.0 million units, nearly all of which were linked to the single recall of multi-purpose cleaners.
Europe:
European consumer electronic product recalls increased 11.5% between Q4 2022 and Q1 2023, with 87 events this quarter. The most common risk was electric shock, which was linked to 41 recalls. Lighting chains were the most recalled product, cited in 17 events.
There were 149 toy product recalls across Europe in Q1 2023, a 31.3% drop from the previous quarter. Chemical risk was the most common reason for recalls with 60 events, while plastic dolls were the most common category of toy recalled, linked to 18 events
There were 77 clothing product recalls in Q1 2023 across Europe, a 2.7% increase on the 75 recall events recorded in Q4 2022. Children’s and baby’s apparel, were responsible for 54 of all recalls, or 70.1%. Injuries were the most common reason, cited in 25 events.
Automotive
United States:
NHTSA issued 245 automotive product recalls in Q1 2023, an increase of 3.4% compared to the previous quarter. The number of recalled units also increased slightly, from 7.5 million in Q4 2022 to 7.6 million.
Electrical systems were the leading cause cited for NHTSA product recalls, linked to 48 events compared to 33 last quarter. This category was also linked to the most units recalled with 1.7 million units, or 22.1%. Equipment had the second most product recall events with 46, though only 263,464 units were impacted.
Automobiles were the largest category of NHTSA product recalls with 216 in Q1. The number of units impacted quarter-over-quarter also held steady with 7.32 million automobiles, compared to 7.30 million in Q4 2022.
Europe:
There was a 2.6% decrease in automotive product recalls across Europe from Q4 2022 to Q1 2023, with the number of events falling from 195 last quarter to 190 this quarter. There were 152 product recalls tied to injuries, reflecting a slight decrease from the 157 reported in the previous quarter.
Passenger cars were the most common product recalled in Q1 with 106 events, a 15.2% decrease from the previous quarter. Passenger car recalls accounted for 55.8% of the total automotive product recalls in Q1 2023.
In Q1 2023, the UK remained the most active country with 83 product recall alerts, a slight decrease compared to the 89 in Q4 2022. Germany issued the second highest number of alerts with 63, followed by France with 30 alerts.
Medical Device
United States:
The number of medical device product recalls marginally increased in Q1 2023 with 252 events compared to 241 recalls in Q4 2022. There was a more dramatic uptick in the number of impacted units, which rose by 34.3% to 83.3 million this quarter.
Manufacturing defects were the leading reason for medical device product recalls, accounting for 59 events or 23.4%. Parts issues were the second-most common concern and were linked to 38 events.
In terms of units impacted, quality concerns accounted for 68.5 million units, or 82.3% of all products recalled in Q1. A single recall for 66.5 million CADD infusion sets was responsible for 79.8% of all units recalled across the sector.
Europe:
There were a total of 790 medical device product recalls across Europe in Q1 2023. This represents a 6.8% uplift on the 740 events recorded in Q4 2022. Software issues were the most common reason for recall, with 115 events. This reflects an 18.6% increase from the 97 events recorded in Q4.
Safety concerns were the second most cited issue, accounting for 97 product recalls, a 70.2% increase from last quarter. That was followed by device failure with 89 events and outside of specifications with 65 events.
France issued the most product recall notifications for medical devices with 205, a 15.8% increase from the previous quarter. Germany was the second top issuer with 187 notifications, down 12.6% from the previous quarter.
Pharmaceutical
United States:
Q1 2023 recorded the highest number of pharmaceutical product recalls in a single quarter in the past 18 years. There were 144 recall events, an increase of 53.2% compared to last quarter. The number of units recalled rose even more dramatically, from 4.2 million to 49.5 million units.
cGMP deviations were the leading cause of pharmaceutical product recalls with 70 events (48.6%). This is the highest number of recalls for cGMP deviations in a single quarter in over five years. cGMP deviations also had the most units recalled in Q1, with 33.2 million.
Failed specifications were the second most common cause for both product recall events and units impacted with 23 events involving 9.64 million units.
Europe:
European pharmaceutical product recalls declined 17.3% in Q1 2023 compared to Q4 2022. There were 86 events compared to 104 the previous quarter. It is worth noting that Q4 was very active with a much higher number of product recalls than the rest of the year.
Safety risks were the leading cause of pharmaceutical recalls, linked to 31 events this quarter. The second-most common concern was foreign materials / contamination with 12 events. In third was mislabelling with 11 product recall events.
France issued the most recall notifications, with 23 or 26.7% of the total figure. The UK followed with 16 notifications, up from 13 in Q4 2022. Germany had 13 notifications (down from 17 in Q4), which put it in third place.
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