We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
BDX Stock Declines Following Class I Classification for Alaris Recall
Read MoreHide Full Article
Becton, Dickinson and Company’s (BDX - Free Report) , or popularly known as BD, initiated the recall of its infusion pumps last month after customer reports indicated software issues, potentially leading to inaccurate therapy administration. The FDA designated BD’s recall of its infusion pump software as Class I, the most severe classification, last week. While no injuries or fatalities have been reported, the FDA warns that continued use of the affected software could result in serious harm or even death if appropriate corrective measures are not implemented.
The affected products include BD Alaris Systems Manager and BD Care Coordination Engine (CCE) Infusion Adapter.
Likely Trend of BDX Stock Following the News
Shares of BDX have lost 0.9% since the Class I classification of the recall last week. The company’s shares have gained 0.5% compared with the industry’s 1.7% growth so far this year. The S&P 500 Index declined 2.7% in the same period.
Image Source: Zacks Investment Research
BD has added the Alaris pump to its portfolio with the acquisition of CareFusion 303 in 2015. It has been selling the Alaris pump under a consent decree till 2023, except for intravenous administration sets and accessories. The consent decree authorized the FDA, in the event of any violations in the future, to order BD’s U.S. infusion pump business to cease manufacturing and distributing products, recall products or take other actions, and order the payment of significant monetary damages. However, BD gained 510(k) clearance from the FDA for its updated BD Alaris infusion system in 2023, which enabled both remediation and a return to market for the system. The relaunch of the Alaris infusion pump boosted the top line by nearly 50 basis points in 2024. Any setback to the pump may lead to a loss of sales going forward.
Reason for the BD's Recall
The recall stems from software issues in BD’s Alaris Systems Manager and BD Care Coordination Engine Infusion Adapter. These programs are critical components that integrate BD’s Alaris infusion pump with hospital electronic medical record systems. Customer reports indicated delayed system responses and a backlog of automated programming requests (APRs), which could result in incorrect therapy administration. This malfunction creates a risk of patients receiving incorrect medication doses, volumes, or infusion rates, potentially leading to severe complications.
Affected BD Systems
The recall specifically affects BD’s Alaris Systems Manager and BD Care Coordination Engine Infusion Adapter, both of which are essential for optimizing the functionality of the Alaris infusion pump. The Alaris pump is widely used to administer essential fluids, including medications and blood products, in a controlled manner. The software glitches could lead to unexpected pump stoppages, inaccurate drug dosing and adverse patient outcomes. BD and its CareFusion subsidiary have advised healthcare facilities to take precautionary steps, such as manually verifying parameters before initiating therapy and notifying BD if affected software is in use.
Historical Recalls in the Infusion Pump Market
BD is not the first company to face regulatory action due to software failures in infusion pumps. In August 2023, Baxter was forced to recall nearly 23,000 devices due to software defects, leading to a Class I recall designation by the FDA. More recently, in May 2024, OptumHealth issued a recall for 208 pumps affected by similar software issues, while Smiths Medical conducted a medical device correction for software-related failures in August 2024. These incidents underscore a broader industry challenge in ensuring the reliability of infusion pump software, which plays a vital role in patient care.
As the global infusion pump market continues to grow, BD and other manufacturers will need to prioritize software integrity to prevent further regulatory scrutiny and safeguard patient safety.
The global infusion pump market, valued at $2.6 billion in 2023, is expected to grow to $3.3 billion by 2033. BD is recognized as a major player in the infusion pump market.
Some better-ranked stocks in the broader medical space are Cardinal Health, Inc. (CAH - Free Report) , Cencora, Inc. (COR - Free Report) and Boston Scientific Corporation (BSX - Free Report) .
Cardinal Health, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 9.5%. CAH’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 9.6%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Cardinal Health’s shares have gained 12.2% compared with the industry’s 1.7% growth so far this year.
Cencora, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 12.1%. COR’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 4.9%.
Cencora has gained 19.5% compared to the industry’s 6% decline year to date.
Boston Scientific, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 13.3%. BSX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 8.3%.
Boston Scientific’s shares have rallied 15.4% compared with the industry’s 7.2% growth so far this year.
Zacks' 7 Best Strong Buy Stocks (New Research Report)
Valued at $99, click below to receive our just-released report predicting the 7 stocks that will soar highest in the coming month.
Image: Bigstock
BDX Stock Declines Following Class I Classification for Alaris Recall
Becton, Dickinson and Company’s (BDX - Free Report) , or popularly known as BD, initiated the recall of its infusion pumps last month after customer reports indicated software issues, potentially leading to inaccurate therapy administration. The FDA designated BD’s recall of its infusion pump software as Class I, the most severe classification, last week. While no injuries or fatalities have been reported, the FDA warns that continued use of the affected software could result in serious harm or even death if appropriate corrective measures are not implemented.
The affected products include BD Alaris Systems Manager and BD Care Coordination Engine (CCE) Infusion Adapter.
Likely Trend of BDX Stock Following the News
Shares of BDX have lost 0.9% since the Class I classification of the recall last week. The company’s shares have gained 0.5% compared with the industry’s 1.7% growth so far this year. The S&P 500 Index declined 2.7% in the same period.
Image Source: Zacks Investment Research
BD has added the Alaris pump to its portfolio with the acquisition of CareFusion 303 in 2015. It has been selling the Alaris pump under a consent decree till 2023, except for intravenous administration sets and accessories. The consent decree authorized the FDA, in the event of any violations in the future, to order BD’s U.S. infusion pump business to cease manufacturing and distributing products, recall products or take other actions, and order the payment of significant monetary damages. However, BD gained 510(k) clearance from the FDA for its updated BD Alaris infusion system in 2023, which enabled both remediation and a return to market for the system. The relaunch of the Alaris infusion pump boosted the top line by nearly 50 basis points in 2024. Any setback to the pump may lead to a loss of sales going forward.
Reason for the BD's Recall
The recall stems from software issues in BD’s Alaris Systems Manager and BD Care Coordination Engine Infusion Adapter. These programs are critical components that integrate BD’s Alaris infusion pump with hospital electronic medical record systems. Customer reports indicated delayed system responses and a backlog of automated programming requests (APRs), which could result in incorrect therapy administration. This malfunction creates a risk of patients receiving incorrect medication doses, volumes, or infusion rates, potentially leading to severe complications.
Affected BD Systems
The recall specifically affects BD’s Alaris Systems Manager and BD Care Coordination Engine Infusion Adapter, both of which are essential for optimizing the functionality of the Alaris infusion pump. The Alaris pump is widely used to administer essential fluids, including medications and blood products, in a controlled manner. The software glitches could lead to unexpected pump stoppages, inaccurate drug dosing and adverse patient outcomes. BD and its CareFusion subsidiary have advised healthcare facilities to take precautionary steps, such as manually verifying parameters before initiating therapy and notifying BD if affected software is in use.
Historical Recalls in the Infusion Pump Market
BD is not the first company to face regulatory action due to software failures in infusion pumps. In August 2023, Baxter was forced to recall nearly 23,000 devices due to software defects, leading to a Class I recall designation by the FDA. More recently, in May 2024, OptumHealth issued a recall for 208 pumps affected by similar software issues, while Smiths Medical conducted a medical device correction for software-related failures in August 2024. These incidents underscore a broader industry challenge in ensuring the reliability of infusion pump software, which plays a vital role in patient care.
As the global infusion pump market continues to grow, BD and other manufacturers will need to prioritize software integrity to prevent further regulatory scrutiny and safeguard patient safety.
The global infusion pump market, valued at $2.6 billion in 2023, is expected to grow to $3.3 billion by 2033. BD is recognized as a major player in the infusion pump market.
Becton, Dickinson and Company Price
Becton, Dickinson and Company price | Becton, Dickinson and Company Quote
BD’s Zacks Rank & Key Picks
Currently, BD carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Cardinal Health, Inc. (CAH - Free Report) , Cencora, Inc. (COR - Free Report) and Boston Scientific Corporation (BSX - Free Report) .
Cardinal Health, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 9.5%. CAH’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 9.6%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Cardinal Health’s shares have gained 12.2% compared with the industry’s 1.7% growth so far this year.
Cencora, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 12.1%. COR’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 4.9%.
Cencora has gained 19.5% compared to the industry’s 6% decline year to date.
Boston Scientific, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 13.3%. BSX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 8.3%.
Boston Scientific’s shares have rallied 15.4% compared with the industry’s 7.2% growth so far this year.