Medical device
The world’s leading product recall company. Supporting the medical device sector since 1995.
CRITICAL RESPONSE: ENSURING MEDICAL DEVICE SAFETY
We are proud to partner with 7/10 of the world’s leading medical device brands.
Medical devices play a pivotal role in patient care, but they also harbor inherent risks. Their criticality underscores the need for manufacturers to prioritize immediate and effective responses to any safety concerns. Failure to act promptly not only jeopardizes patient well-being but also amplifies the reputational and financial fallout.
Continuous surveillance and stringent quality safety protocols are indispensable. Manufacturers must remain vigilant, conducting ongoing evaluations to swiftly identify emerging issues. Proactive monitoring allows for timely interventions, averting potential risks to patient health while mitigating the broader impact on the company’s reputation and viability in the industry.
Since 1995, we’ve partnered with the world’s leading medical device brands to develop, test and execute over 7,000 product recall and remediation programs across 100 countries and 50 languages.
Whether you’re planning for — or currently facing — a product recall, market withdrawal or any other in-market product incident, our experts are on hand to support you.
PRODUCT RECALL MANAGEMENT FOR DEVICE MANUFACTURERS
Expert guidance in developing, testing, and executing comprehensive product recall plans.
The threat posed by medical device failures to patient well-being necessitates manufacturers maintain vigilant monitoring. As the industry evolves, emerging risks such as cyber-attacks targeting connected devices underscore the crucial need for robust recall readiness and swift corrective action to address device vulnerabilities.
Alongside cyber threats, a myriad of other risks including mounting supply chain pressures, enhanced pathogen detection, heightened regulatory scrutiny, and the growing influence of digital health have contributed to a 6.5% increase in global device recalls in the past 5 years.
With three decades of industry experience, we are uniquely qualified to address the most intricate of medical device product recalls and corrective actions. Whether navigating complex regulatory demands and compliance specifications, orchestrating seamless patient notification and response programs, or managing product retrieval, field repair or device destruction – we have the experience to help.
ESSENTIAL INSIGHT
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 medical device safety. Access high-level insights below and download our latest edition in full.
U.S. MEDICAL DEVICE SAFETY & RECALL INSIGHTS
Quarter 2, 2024
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.
Quarter 1, 2024
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.
Quarter 4, 2023
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.
Quarter 3, 2023
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.
EUROPEAN MEDICAL DEVICE SAFETY & RECALL INSIGHTS
Quarter 2, 2024
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.
Quarter 1, 2024
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.
Quarter 4, 2023
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.
Quarter 3, 2023
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.
MEDICAL DEVICE REMEDIATION
While not every device issue mandates a formal recall, swift and cautious action is indispensable in ensuring patient safety.
Whether regional, national or global in scale, protecting patients and brands from defective devices in the marketplace requires speed. In the event of a medical device market withdrawal, product recall or consumer complaint, our global team of field representatives mobilizes within 24 hours to correct faulty medical devices on-site, install software updates, retrieve devices for disposition, or return them to manufacturers for testing. Our fast and effective on-site visits allow for the retrieval of affected products, while follow-up audits verify that medical devices were removed or repaired properly.
Leveraging three decades of industry experience and expertise, our proven best practice strategies and executional proficiency provide comprehensive support to medical device manufacturers. Our global on-site device corrections span hospitals, physician’s offices, and even patient homes, ensuring swift and accurate repair or removal of potentially harmful devices from the market.
INDUSTRY-LEADING CALL CENTER SOLUTIONS
With Sedgwick Brand Protection, gain 24-7-365 access to a global team of brand ambassadors ready to field calls from concerned patients.
Our expertise extends beyond the handling and resolution of product recall inquiries, to encompass a wide range of business and drug related challenges – from market withdrawals, product safety alerts, corrective action programs, and much more. Since 1995 we have provided the medical device industry with:
- Instant on-demand support that adds flexibility and agility to existing customer engagement infrastructures, alleviating pressure on resources as call volumes surge – ensuring vital day-to-day business operations are not compromised.
- Scalability in size and duration, from short-term engagements to long-term programs in response to one-time product recalls or persistent issues. Flexibility on-demand – simply dial up and down as required.
Case study
Recalling a medical device critical to patient health when regulators demand 'immediate' action.
Case study
End-to-end recall management, including a 40+ country multi-lingual call center operation.
Download our Recall Index
Essential insight and analysis for mitigating product recall risk
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.
About us
Since 1995, we’ve helped the world’s leading brands uphold their commitments of product safety to customers, supply chain partners and regulators. Our unrivalled experience spans more than 7,000 of the most sensitive and time-critical recall events, in over 100 countries and 50 languages. Discover more.
Industry-leading solutions
From product recall readiness audits and mock recall simulations, to complete turn-key withdrawal, 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. Discover more.
Essential product safety insight
Featuring unrivalled analysis and perspective on the latest product safety regulation and recall trends, the Index report is the definitive guide to help mitigate recall risk, litigation, and reputational damage caused by product crises and in-market events. Downloaded in over 100 countries – get your copy now.
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Whether you’re planning for — or currently facing — a product recall, market withdrawal, or any other in-market product incident, our experts are on hand to support you.