The world’s leading product recall company

United States:

FDA food and drink product recalls dropped by 11.9% in Q2 2024 compared to Q1, falling to 118 events. The number of impacted units declined by 68.5%, from 30.72 million in Q1 to 9.68 million in Q2.

In Q2 2024, there were 41 product recalls for undeclared allergens, continuing its streak as the leading cause of FDA food recalls. Bacterial contamination was the second-highest cause of FDA food recalls in terms of events with 37. By volume, bacterial contamination had the highest number of units recalled with 8.94 million.

The number of Class I recalls in Q2 2024 fell 35.6%, from 59 in Q1 to 38. The number of impacted units in this designation fell 10.2%, from 3.06 million to 2.75 million.

Europe:

In Q2 2024, regulators in the EU and UK reported 1,437 food and beverage product recalls. This marks a 6.3% increase over Q1 and a 10-year quarterly high for the sector.

The leading cause of food and beverage product recalls this quarter was non-bacterial contamination, with 544 events, followed by  bacterial contamination which cited in 322 recalls.

As it has for the last 16 quarters, fruits and vegetables experienced the most recalls. There were 231 events in Q2 2024, down from 262 last quarter. Nuts, nut products, and seeds was the second-most impacted category with 157 recalls.

Download our latest Recall Index reports

United States:

In Q2 2024, there were 86 CPSC recalls, down 6.5% from Q1 2024. In contrast, the number of units increased by 67.3%, from 23.36 million in Q1 to 39.07 million in Q2.

Comparing the half-year (H1) 2024 with H1 2023, the 178 product recalls recorded to the end of June this year are 4.7% more than the 186 in H1 2023.The number of units recalled is higher with 62.43 million units recorded in H1 2024, compared to 43.78 million in H1 2023.

Sports & Recreation accounted for the most recalls by product category in Q2 2024, linked to 25 events. Home Furnishings and Décor was second with 13 recalls, and Children’s Products was third with nine events.

Europe:

Consumer electronic product recall events across the EU and UK decreased by 56.6% between Q1 and Q2 2024, from 281 to 122. It is noteworthy that Q1 experienced the most consumer electronics recalls in more than 10 years. Electronics product recalls spread across 72 different product categories in Q2 2024. Lighting chains were the most common product impacted, tied to 13 recalls.

There were 162 toy product recalls across the EU and UK in Q2 2024, a slight increase from the 161 in Q1 2024. Choking was the most prevalent cause of European toy product recalls in Q2 2024 with 59 events. There were 15 recalls for soft toys, making it the top category in Q2 2024.

There were 53 clothing product recalls in Q2 2024, up 12.8% compared to the 47 events in Q1 2024. The combination of injuries and strangulation was the most common reason for clothing recalls, cited in 19 events in Q2 2024.

Download our latest Recall Index reports

United States:

In Q2 2024, NHTSA issued 243 automotive product recalls, a 7.3% decrease compared to Q1 2024. The number of units fell by 60.1% from 12.45 million in Q1 to 4.97 million in Q2. For context, only one quarter in the past 10 years has recorded fewer impacted units.

Despite the lower numbers in Q2, figures remain ahead of 2023 at the half-way point in the year (H1). At the close of H1 2023, there were 479 automotive product recalls impacting 15.82 million vehicles. By comparison, there have been 505 recalls with 17.42 million vehicles affected in H1 2024.

Equipment was the leading cause of automotive product recalls and was linked to 42 events.

Europe:

There was a 9.3% increase in automotive product recalls across the EU and UK from Q1 2024 to Q2 2024. Events rose from 162 last quarter to 177 this quarter. There were 136 recalls tied to injuries in Q2 2024, making it the leading cause across the automotive industry.

Passenger cars were the most common category recalled in Q2 2024 with 105 incidents. Light commercial vehicles, including passenger vans, were second with 19 events. Motorcycles were third with 14 recalls.

The same three countries have submitted the most recall notifications for the past six quarters, largely in the same order. The UK issued the most notifications in Q2 2024 with 82. Germany had the second-most with 56 notifications. France ranked third with 17 alerts submitted.

Download our latest Recall Index reports

United States:

In Q2 2024, medical device recall events decreased by 18.2% compared to Q1 2024, dropping to 242. In contrast, the number of units impacted rose by 267.3% from 53.40 million in Q1 to 196.15 million in Q2. This is the highest number of units in two years.

Quality issues was the leading cause of recall activity in the sector, accounting for 26 events in Q2 2024. Parts concerns was the second-most common cause with 24 events.

Both the number and volume of Class I medical device recalls decreased in Q2 from 33 events to 30, and from 19.07 million units to 1.81 million.

Europe:

There were 893 EU and UK medical device product recalls in Q2 2024, down 4.5% from Q1. For context, the 935 recalls last quarter represented the highest figure in four years.

Software concerns was the leading cause of European medical device product recalls in Q2 2024 with 136 events. This is up 29.5% compared to the 105 recalls in Q1 2024. Device failure was second, accounting for 103 recalls. There were 88 medical device recalls attributed to safety concerns, placing it third.

The same three countries have issued the most medical device recall alerts every quarter since Q1 2021. Germany led with 227 notifications in Q2 2024, France issued 200 alerts, putting it in second place. Italy was third with 159 notifications.

Download our latest Recall Index reports

United States:

The number of units impacted by FDA pharmaceutical product recalls decreased 51.2% from 9.30 million in Q1 2024 to 4.54 million in Q2. For context, there have only been five other quarters in the past 15 years with fewer units recalled. The number of events was also lower, dropping from 112 recalls in Q1 2024 to 93 events in Q2.

Failed specifications was the leading cause of pharmaceutical product recalls with 21 events. Sterility was the second-most common concern in Q2 2024, linked to 15 recalls.

Class I recalls decreased by 42.9%, from 21 events in Q1 to 12 in Q2. This quarter saw a total of 46,527 units impacted, representing a significant 99.1% reduction from the 5.32 million units classified as Class I in Q1.

Europe:

In Q2 2024, there were 69 pharmaceutical product recalls across the UK and EU. This is up 9.5% compared to 63 events in Q1 2024.

Failed specifications was the leading cause of pharmaceutical product recalls in Q2 2024. It was linked to 17 events, up from seven events in Q1 2024. Safety risks was second with 14 recalls.

The UK recorded the most notifications of any country in Q2 2024 with 14. Italy was second with 13, and Spain and France tied for third with 10 alerts each.

Download our latest Recall Index reports

United States:

The number of FDA food and drink product recalls rose by 27.6% in Q1 2024 compared to Q4 2023, increasing to 134 events. This is the second-highest quarterly number of FDA recalls in the past four years. The number of units impacted increased even more dramatically, going from 6.20 million units last quarter to 30.72 million in Q1.

There were 51 product recalls for undeclared allergens, making it the leading cause of U.S. food and drink recalls for every quarter, bar one, in the last seven years. Bacterial contamination was the second highest cause in terms of events with 34 product recalls in Q1.

The number of Class I recalls in Q1 2024 rose to 59 compared to 47 in Q4.

Europe:

In Q1 2024, regulators in the EU and UK reported 1,352 food and drink product recalls, the highest single-quarterly total over the last five years.

The leading cause of food and drink recalls this quarter was non-bacterial contamination with 557 events, followed by bacterial contamination which was cited in 209 recalls.

Fruits and vegetables again were the most recalled product. There were 262 events in Q1 2024, up from 216 last quarter. Nuts, nut products, and seeds was the second-most impacted category with 174 product recalls, higher than the 139 recalls last quarter. Dietetic foods, food supplements, and fortified foods was the third-highest product category with 100 recalls.

Download our latest Recall Index reports

United States:

In Q1 2024, there were 92 CPSC recalls, up 5.7% from Q4 2023. However, the number of recalled units dropped by 71.8% to 23.36 million compared to 82.79 million in Q4.

Fire was the leading cause of consumer product recalls by event in Q1 2024, tied to 19. This has been the leading product risk for the past 4 quarters. Burns was the second-leading concern with 15 events, followed by injury with 13 product recalls.

Sports & Recreation accounted for the most recalls by product category, linked to 24 events in Q1 2024. Children’s Products was second with 16 recalls, and Electronics was third with 13 events.

Europe:

Consumer electronics product recall events across the EU and UK increased 62.4% from 173 in Q4 2023 to 281 in Q1 2024. This marks their highest reported level in over ten years. The most prevalent risk was electric shock, which was linked to 74 product recalls as a single concern. When other issues such as fire, burns, and explosions are added, the total rises to 93.

There were 161 toy product recalls across the UK and EU in Q1 2024. That is a 19.3% increase from the 135 events in Q4 2023. Chemicals by itself was the most prevalent cause of European toy recalls in Q1 2024 with 49 events, up from 36 recall events last quarter.

There were 47 European clothing product recalls in Q1 2024, up 42.4% compared to the 33 events in Q4 2023. Children’s dresses had the most recalls of any product category in Q1 with nine events. Children’s shoes, children’s sweatshirts, and children’s trousers were the next most common categories.

Download our latest Recall Index reports

United States:

In Q1 2024, NHTSA issued 262 automotive product recalls, a 9.2% increase compared to Q4 2023 and the most recalls in a single quarter since Q3 2021. The number of automotive recalled units fell from 14.69 million in Q4 2023 to 12.45 million in Q1 2024.

Electrical systems was the leading recall cause for the fifth consecutive quarter with 66 events. Equipment was the second-most common concern, cited in 36 product recalls. Air bags was the most common reason for automotive recalls by volume in Q1 2024 with 2.96 million units impacted.

Automobiles was the largest product category of recalls with 232 events. The equipment category had 29 recalls that impacted 1.98 million units.

Europe:

There was a 52.8% increase in automotive product recalls across Europe, from 106 in Q4 2023 to 162 in Q1 2024. There were 125 recalls tied to injuries in Q1 2024, making it the leading cause.

Passenger cars was the most common product category recalled in Q1 2024 with 107 incidents, up from 74 recalls in the previous quarter. Vans were the second-most recalled product with nine events, and motorcycles were third with eight.

Germany issued the most automotive product recall notifications in Q1 2024 with 70, up from 44 in Q4 2023. The UK had the second most with 66, compared to 22 last quarter. France submitted eight automotive recall alerts in Q1 2024, putting it in third place.

Download our latest Recall Index reports

United States:

In Q1 2024, the number of medical device recall events increased by 13.8% compared to Q4 2023. The 296 recalls this quarter is the second highest since Q2 2018. The number of units impacted fell by 51.2% from 109.35 million in Q4 to 53.40 million in Q1.

Quality issues was the leading cause of recall activity in the sector, accounting for 51 events in Q1 2024. Sterility concerns was the second-most common cause with 35 events, up 169.2% from 13 events last quarter.

In terms of volume, sterility was the leading cause accounting for 12.49 million defective units. This was followed by Quality issues with 10.66 million and Parts issues with 9.01 million.

The total number of Class I medical device recalls reached a ten-year high in Q1 2024 with 33 events.

Europe:

There were 935 European medical device recalls in Q1 2024, breaking the previous single-quarter record of 900 set in Q3 2023. This reflects a 9.1% increase compared to the previous quarter.

Device failure was the leading cause of medical device recalls in Q1 2024 with 123 events. Software concerns was the second-most cited issue, accounting for 105 events. There were 84 medical device recalls attributed to Safety concerns, making it the third-most common cause of recalls this quarter.

The top countries issuing medical device recall alerts in Q1 2024 mirrored the results in Q3 and Q4 2023. Germany led with 216 recall notifications, followed by France with 198 recall alerts this quarter.

Download our latest Recall Index reports

United States:

There was a 14.5% decrease in pharmaceutical product recalls, from 131 in Q4 2023 to 112 in Q1 2024. The number of recalled units fell by 46.3% from 17.31 million in Q4 to 9.30 million in Q1.

Failed specifications was the leading cause of pharmaceutical recalls with 26 events. Contamination was the second-most common concern in Q1 2024, linked to 21 product recalls.

In terms of volume, sterility issues impacted the most pharmaceutical units with 5.38 million. Contamination was second with 1.21 million units, of which 7.8% were connected to two recalls for benzene.

Europe:

In Q1 2024, there were 63 pharmaceutical product recalls across the UK and EU. This is down 3.1% compared to 65 events in Q4 2023 and marks the second-lowest quarterly recall figure recorded in the past three years.

Safety risks were the leading cause of pharmaceutical product recalls and were linked to 18 events this quarter, a decrease from 24 events in Q4 2023. Failed specifications and Manufacturing errors tied for the second-most common concern.

France remained the leading pharmaceutical recall notifier for the second consecutive quarter, issuing 12 alerts in Q1 2024, down from 16 last quarter. Spain was second with 11 recall notifications.

Download our latest Recall Index reports

United States:

Compared to Q3 2023, Q4 had fewer total product recalls and fewer units impacted. There were 105 FDA food recalls in Q4, down 19.8% from Q3. There were 6.20 million units recalled, an 84.6% decrease from the previous quarter.

There were 42 recalls for undeclared allergens, making it the leading cause of U.S. food and drink product recalls for all but one quarter over the last 6 years. Bacterial contamination was second in terms of events with 25 recalls in Q4. Non-bacterial contamination drove the highest volume of FDA food and drink recalls in Q4, accounting for 3.07 million units.

Produce was the top recalled product category in Q4 2023 in terms of events with 27 recalls, followed by Prepared Foods with 19 recalls and Baked Goods with 15.

Europe:

Q4 2023 marked the fifth consecutive quarter of growth of product recalls in the food and beverage sector. European regulators reported a total of 1,308 recall events during this period, reflecting a 9.5% rise compared to Q3.

The leading cause of food and beverage recalls in Q4 was non-bacterial contamination, with 578 events, up from 470 last quarter. The most common contaminants of concern were aflatoxins and pesticides. The second leading concern was bacterial contamination with 241 recalls. Salmonella was the most common risk and was tied to 146 recalls, followed by Listeria with 37, and E. Coli with 29.

In Q4 2023, Fruits and vegetables was the most recalled product category 216 recalls, followed by nuts, nut products, and seeds with 139 recalls.

Download our latest Recall Index reports

United States:

The CPSC issued 87 product recalls in Q4 2023, up from 65 events in Q3. The change in units impacted was more significant, rising by 855.5% from 8.67 million last quarter to 82.79 million in Q4. Only two years in the last ten have recorded more impacted units.

Fire was the top consumer product hazard by event in Q4 2023, tied to 16 recalls, followed by Injury with 14 events and falls with 10 recalls. Choking was the top risk by unit with 70.64 million units impacted, followed by fire with 7.08 million units affected.

Children’s Products accounted for the most recalls by product category, linked to 21 events in Q4 2023. In terms of units impacted, Children’s Products was also the top product category with 70.88 million units recalled, or 85.6% of all units in Q4 2023.

Europe:

There were 173 consumer electronic product recalls across the EU and UK in Q4 2023, up 57.3% from Q3 and setting the new record for the most recalls in a single quarter. This record was previously set with 168 recalls in Q2 2023. The most common risk was environment, which was linked to 79 recalls. This marks the first quarter in more than 10 years that environment has been the leading cause.

For Q4 2023, there were 135 toy product recalls across the UK and EU, a 31.1% increase from the 103 events in Q3 2023, but a 37.8% decline from the 217 recall events from Q4 2022. Choking was the most common reason for toy recalls in Q4 2023 with 45 events. When combined with other risks such as injuries and suffocation, the total rises to 66. Chemicals was the second most-cited concern with 36 recalls.

There were 33 clothing product recalls across the UK and EU, representing a decline of 44.1% on Q3 2023. Hooded sweatshirts had the most recalls of any product category in Q4 with five events. If all categories of sweatshirts are considered, the total increases to seven. Tracksuits were the second-most common category with three recalls, and children’s flip-flops and children’s shoes had two recalls each.

Download our latest Recall Index reports

United States:

Looking at Q4 2023, NHTSA issued 240 automotive product recalls, a 21.8% increase compared to the previous quarter. The number of vehicles impacted was also higher, increasing from 7.92 million in Q3 to 14.69 million in Q4. This is the highest quarterly total since Q1 2020 and the third highest since Q3 2016.

Electrical systems was the leading cause of U.S. automotive recalls in every quarter of 2023. It was linked to 53 events in the final quarter, compared to 41 in Q3, 51 in Q2, and 48 in Q1. Structure was the second-most common concern in Q4, cited in 28 recalls, and equipment was third with 26 events. Electrical systems was also the most common reason for automotive recalls by volume in Q4 2023 with 4.92 million units impacted.

Europe:

There was a 51.2% decrease in automotive  product recalls from Q3 to Q4 2023. The number of events declined from 217 to 106. There were 84 product recalls tied to injuries in Q4 2023, reflecting a 48.8% decrease from the 164 reported in the previous quarter. Fire risk was the second-most common cause for recalls, linked to 10 events. Environment was third with six product recall events.

Passenger cars were the most common product category recalled in Q4 2023 with 75 events, a significant decrease from the 147 recalled in Q3. Motorcycles were the second-most recalled product category with five events. Germany issued the most notifications in Q4 with 44, down from 68 in Q3. The UK had the second-most with 22, 77.1% fewer than last quarter.

Download our latest Recall Index reports

United States:

The number of medical device recalls and units affected were both higher in Q4 than in Q3 2023. There were 260 recalls, a 17.1% increase from the 222 events in Q3. The number of impacted units rose by 346.6% to 109.35 million in Q4.

Quality issues was the leading reason for medical device recalls in the sector, accounting for 44 events in Q4 2023. Mislabeling concerns was the second-most common cause with 31 events, followed by parts issues with 25 recalls. In terms of volume, products out-of-specifications was the top reason for recalls in Q4 2023 affecting 50.78 million units.

The number of recalls and units impacted rose for Class I and II medical devices between Q3 and Q4 2023. The number of units involved in Class I recalls rose from 649,124 across 19 events in Q3 to 81.31 million units across 28 recalls in Q4.

Europe:

Looking at the final quarter of the year, there were 853 medical device recalls, marking a 5.2% decrease compared to the 900 recorded in Q3 2023. It is worth noting however that Q3 witnessed the highest number of European medical device recalls in a single quarter in the past three years.

Device failure was the most common reason for Q4 2023 medical device recalls with 171 events. This reflects a 92.1% increase from Q3 2023 for this risk. Safety concerns were the second-most cited issue, accounting for 109 recalls.

Germany issued the most recall notifications for medical devices this quarter with 194, down slightly from 199 in Q3 2023. France had 181 alerts this quarter, compared to 197 from Q3 2023.

Download our latest Recall Index reports

United States:

Q4 2023 saw a 22.4% increase in pharmaceutical product recalls, growing from 107 events last quarter to 131 this quarter. The number of units also increased, rising 133.3% from 7.42 million in Q3 to 17.31 million in Q4.

Poor temperature control was the leading cause of pharmaceutical recalls with 40 events. This is the first time in over eight years that this has been the top concern. Failed specifications was the second-most common cause for pharmaceutical product recalls by event with 27.

The number of events rose for all classes of recall severity in Q4. The biggest change was for Class I recalls, which increased from eight events in Q3 to 26 in Q4.

Europe:

In Q4 2023, there were 40.9% fewer pharmaceutical product recalls compared to Q3 2023. The final quarter of the year closed with 65 events, down from 110 in Q3. Only one quarter in the past three years has recorded fewer events (Q3 2022 with 60).

Having dominated European pharmaceutical product recall activity in 2023, safety risks closed the year with 24 events in Q4, marking a 9.1% uplift on the 22 events recorded in Q3. Mislabelling was the second-most cited reason for recall with seven events.

France issued the most pharmaceutical recall notifications, with 16 alerts in Q4 2023, down from 20 in the previous quarter. Germany was second with 15 recall notifications, and Spain was third with 13 alerts. The UK had six notifications this quarter compared to 19 in Q3.

Download our latest Recall Index reports

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.

Download our latest Recall Index reports

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.

Download our latest Recall Index reports

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.

Download our latest Recall Index reports

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.

Download our latest Recall Index reports

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.

Download our latest Recall Index reports