The US Food and Drug Administration (FDA) has issued import alerts for select Olympus Medical Systems devices manufactured in Japan due to due to unresolved concerns related to quality system regulation violations.

The affected devices include specific models of ureterorenoscopes, bronchoscopes, laparoscopes, and automated endoscope reprocessors. These products, produced by Olympus Medical Systems Corporation and its subsidiaries, will now be refused entry into the US under Import Alert 89-04, which cites noncompliance at Olympus’ Aizu manufacturing facility.

The FDA says in the alert that it has taken actions related to quality system requirements and compliance concerns with Olympus and that it is continuing to engage with the company to accelerate corrective actions related to the ongoing violations and minimize risk to patients. 

“FDA takes seriously its role in assuring patients that medical devices are safe and effective,” reads the alert from the agency. 

What Health Care Providers Should Know

According to the FDA, health care providers should:

• Be aware of the import alerts and consult the FDA’s table of affected models and Unique Device Identifiers.
• Note that the alerts do not apply to related products such as replacement parts, connectors, or single-use consumables.
• Continue using devices already in use, provided they are functioning properly and not showing signs of damage.
• Follow all labeling and reprocessing instructions for cleaning and sterilization.
• Remove from service any devices that are damaged or fail a leak test.
• Establish maintenance and inspection schedules per manufacturer guidance.
• Discuss risks and benefits with patients prior to procedures involving the affected devices.
• Promptly report any adverse events to the FDA to aid in ongoing safety monitoring.

The FDA emphasizes its ongoing engagement with the company to ensure corrective actions are implemented and patient safety risks are mitigated. The FDA says it will update providers and the public as more information becomes available.

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Medtronic has issued a voluntary recall notice for specific Newport HT70 and HT70 Plus ventilators, as well as certain related Newport service parts, advising customers to discontinue clinical use of the affected devices.

According to the company, an investigation into customer complaints identified two separate capacitors on the ventilator’s controller printed circuit board assembly (PCBA) that could fail. If either component fails, it may result in the ventilator shutting down during use or in the shutdown alarm not sounding effectively.

No instances of both capacitors failing on the same PCBA board have occurred, nor are they anticipated to occur, according to a company release.

If a ventilator fails and does not provide adequate ventilation, the patient may not be able to breathe on their own, leading to low oxygen levels, high carbon dioxide levels, and potentially severe consequences like brain injury or death. There have been 63 medical device reports associated with this issue, including two serious injuries and one death. 

HT70 and HT70 Plus ventilators are intended for use by home users, as well as for infant and pediatric patients who may be at higher risks of injury or death due to unanticipated ventilator failures.

Customers should remove the affected devices from use and replace with an alternate means of ventilation. Medtronic is not correcting these issues on affected ventilators or service parts and will no longer service affected ventilators identified in this notification. 

The US Food and Drug Administration (FDA) designated this recall a Class I recall, the most serious type. Medtronic notes in a release that it will continue working with the FDA and other regulatory bodies on this recall. 

In February 2024, Medtronic announced its decision to exit the ventilator business, including the Newport product line. The company says it will continue to fulfill existing contracts and work with regulators as it winds down operations.

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Zyno Medical is recalling certain Z-800 series infusion pumps due to a software issue, according to a medical device recall notice from the US Food and Drug Administration, which notes that this recall involves removing the devices from where they are used or sold.

Zyno Medical stated that certain Z-800, Z-800F, Z-800W and Z-800WF infusion pumps were released to customers with incorrect software versions that had not undergone required verification and validation testing. As a result, these pumps can experience unexpected performance problems, including issues with essential functions and risk measures such as air in line detection, alarm volume, and reverse flow prevention.

The worst case scenarios of incorrect air in line detection and incorrect audio alarms associated with other failures could result in serious harms such as under- or over-delivery of drugs, air in line that infuses a venous air embolism of up to 1mL, undetected flow reversal of drugs or parenteral fluids, and lowering of the Keep Vein Open (KVO) rate from 5 mL/hr to 1 mL/hr, which can lead to very low KVO flow rates and possibly cause a blood clot to form at the distal end of the catheter, ultimately leading to peripheral IV catheter (PIV) failure.

At this time, Zyno Medical has not reported any serious injuries or deaths. The FDA has identified this as a Class I recall, the most serious type. 

What to Do

On May 7, 2025, Zyno Medical sent affected customers an email recommending the following actions:

• Discontinue use of affected devices and follow instructions for the return of the device.
• Check inventory for affected products, verify serial numbers, and confirm product location.
• Report any transferred product and pass this notice to the appropriate personnel who need to be informed if the identified devices have been transferred to another location.
• A representative from Zyno Medical’s partner company, Intuvie LLC, will be in contact with you to coordinate instructions on exchanging devices to remediate this action.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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Medtronic and its subsidiary, Covidien, are recalling the Shiley adult flexible tracheostomy tube with TaperGuard cuff reusable inner cannula as the tube may become dislodged or move out of place if the securement flange becomes disconnected, according to a medical device recall notification from the US Food and Drug Administration. 

This could prevent patient breathing and/or block the airway, which may lead to a serious or life-threatening emergency.

On Feb 26, 2025, Medtronic sent all affected customers an Urgent Medical Device Recall notice regarding the affected tracheostomy tube, recommending the following actions:

• Quarantine all unused product from the affected lot of Shiley adult flexible tracheostomy tube with TaperGuard cuff reusable inner cannula.
• Return all unused product from the affected lot in your inventory to Medtronic as described on the Customer Confirmation Form.

The use of a device that has disconnected the flange from the device cannula may result in respiratory failure, airway tissue injury, choking, respiratory tract infection, tightening of the airways, treatment delay, and/or death.

Medtronic has not reported any serious injuries or deaths associated with this issue.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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Baxter has issued a letter to affected customers recommending Novum IQ large volume pumps to be corrected prior to use due to a potential for underinfusion, according to a medical device recall notice from the US Food and Drug Administration (FDA).

The correction is recommended if the device has been powered off with the administration set loaded, or after the “standby mode” feature has been activated. Keeping the administration set loaded in the pump for an extended amount of time may result in underinfusion due to the compression of the set. The risk increases when infusing at higher flow rates after a longer duration in standby mode or powered off.

These large volume pumps are intended to provide intravenous infusion of drugs, IV nutrition, blood, and blood products. Underinfusion can lead to patient dehydration, inadequate drug therapy, and nutrition. Underinfusion in pediatric patients may create an increased risk of morbidity and mortality.

Baxter has reported one serious injury and no deaths associated with this issue.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Photo caption: Novum IQ large volume pumps

Photo credit: Baxter

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BiVACOR, a clinical-stage medical device company developing a titanium Total Artificial Heart, announced that its device has received Breakthrough Device Designation from the US Food and Drug Administration (FDA).

The designation supports the BiVACOR Total Artificial Heart as a bridge to transplant for adults with severe biventricular or univentricular heart failure where current treatments, including LVADs, are not viable. The FDA’s Breakthrough Device program is reserved for technologies that may significantly improve outcomes for patients with life-threatening or irreversibly debilitating conditions. It offers priority regulatory interaction and accelerated pathways to approval.

“This is more than a regulatory milestone. It’s a validation of a concept we’ve spent decades proving that a fully implantable, total artificial heart isn’t just possible, it’s necessary,” says Daniel Timms, PhD, founder and chief technology officer of BiVACOR, in a release. “Patients with biventricular failure have been overlooked for too long. The early results from our clinical trial show that we can give them a second chance, without the compromises of older technologies. The Breakthrough Device Designation puts us on a faster track to deliver exactly that.”

Trial Expansion Follows Early Success

The designation follows the first phase of BiVACOR’s FDA Early Feasibility Study, where five patients in the US received the Total Artificial Heart between July and November 2024. Based on positive safety and performance data, the FDA approved the expansion of the trial to include 15 additional patients starting later this year.

BiVACOR’s device represents a new category in artificial heart technology. Compact enough to fit most men and women, the Total Artificial Heart uses magnetic levitation, similar to maglev trains, to suspend a single dual-sided rotor. This rotor simultaneously powers the right and left circulatory systems, mimicking the natural heartbeat without valves or mechanical wear points. Its simplified design allows for pulsatile flow, large blood gaps to reduce trauma, and long-term durability.

“We’ve seen every kind of artificial heart technology over the last four decades, but this is the first system I’ve encountered that combines engineering elegance, efficiency, and safety with true clinical viability,” says William Cohn, MD, BiVACOR chief medical officer and heart surgeon at the Texas Heart Institute, in a release. “The early results are remarkable with no strokes, no device-related complications, and a safety profile unlike anything in this space. With Breakthrough status in hand, we’re entering the next phase with the wind at our backs and real momentum to bring this to more patients.”

Heart failure affects more than 6 million Americans, and thousands of patients each year progress to irreversible biventricular failure. However, the number of available donor hearts remains stagnant, with fewer than 4,500 transplants performed annually in the US. BiVACOR is targeting this gap with a durable artificial replacement engineered for eventual long-term support.

The BiVACOR Total Artificial Heart is currently investigational and not approved for commercial use.

Photo caption: Total Artificial Heart

Photo credit: BiVACOR

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The US Food and Drug Administration (FDA) has classified three recent safety notices from Smiths Medical regarding its CADD-Solis Ambulatory Infusion Pumps and CADD-Solis VIP pumps as Class I recalls—the agency’s most serious designation.

The corrections involve updates to device instructions rather than product removals, but the FDA warns that failure to follow the new guidance could lead to serious injury or death depending on the clinical context and medication being infused. Smiths Medical has not reported any injuries or fatalities associated with the issues.

The updates address the following concerns:

• Infusion Pump False Occlusion Alarm: Under certain conditions, a CADD-Solis pump may trigger a false Upstream Occlusion (USO) Alarm. The erroneous USO alarm may occur when there is a delay of more than one hour between the first prime or infusion of a new CADD Administration Set and the next prime or infusion of the same CADD Administration Set. The USO Alarm is a high-priority alarm that will interrupt an ongoing infusion or delay initiation of an infusion. The pump cannot resume or start an infusion until the alarm is cleared.
• Infusion Pump Thermal Damage Issue: Damage to the rechargeable battery pack circuit board, Wireless Communication Circuit Board, or battery separators is associated with the potential for thermal damage in affected infusion pumps. Damage to or inoperable batteries may lead to a delay in therapy or interruption of therapy. The user would be alerted with the normal “Low Battery” or “Depleted Battery” alarms. The presence of excessive heat from damaged or shorted components is also possible, which may result in a thermal injury.
• Infusion Pump Intermittent Connection Issue: CADD-Solis pumps may lose communication with the CADD wireless communication module if wireless network setting changes on the hospital network are not compatible with the CADD wireless communication module. This may result in a “Wireless Module Intermittent Connection” high priority alarm, which will stop an ongoing infusion. When this alarm triggers, the pump must be power cycled to clear the alarm.

Smiths Medical has issued updated use instructions to affected customers and continues to monitor the situation. The FDA urges healthcare professionals to follow the revised guidance to ensure patient safety.

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The number of medical device recalls in the US dropped nearly 9% in the first quarter of 2025, marking the lowest total recorded in three years, according to Sedgwick’s latest US Product Safety and Recall Index.

There were 236 medical device recalls between January and March 2025, down from 259 in Q4 2024. The total number of units affected fell even more significantly, decreasing 42.1% to 18.58 million—making it the third-lowest quarterly figure in the past eight years.

Despite the overall decline in recall activity and volume, Class I recalls—the FDA’s most serious designation—rose from 25 to 31 quarter-over-quarter. Only one quarter in the past two decades, Q1 2024, recorded more Class I events (33).

Device failures were the leading cause of recalls, responsible for 48 events, followed by software issues (31 recalls) and mislabeling (24 recalls). In terms of volume, safety concerns accounted for the most units affected, driven primarily by a recall of 6.22 million sampling lines and airway adapters and a separate recall of 1.17 million assorted medical tools.

Device failure was the second most common reason for medical device recalls by volume, with 3.65 million recalled units, followed by sterility concerns, which accounted for 1.37 million. Class III unit recalls saw the steepest drop, falling 95.7% compared to the previous quarter. Class I and II units also declined by 57.7% and 40.9%, respectively.

The full Sedgwick report also notes that reduced staffing and funding at federal agencies—including the US Food and Drug Administration—may impact recall response timelines and enforcement activity in the months ahead.

The Q1 2025 Recall Index tracks product safety trends across five industries: medical devices, pharmaceuticals, consumer products, automotive, and food and beverage.

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The US Food and Drug Administration (FDA) announced plans to scale use of artificial intelligence (AI) internally across all FDA centers by June 30, following the completion of a new generative AI pilot for scientific reviewers.

“I was blown away by the success of our first AI-assisted scientific review pilot. We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process. The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies,” says FDA commissioner Martin A. Makary, MD, MPH, in a release.

The generative AI tools allow FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process.

“This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take three days,” says Jinzhong (Jin) Liu, deputy director, Office of Drug Evaluation Sciences, Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER), in a release.

Rolling Out AI to All Centers

To reflect the urgency of this effort, Makary has directed all FDA centers to begin deployment immediately, with the goal of full integration by the end of June. Work will continue to expand use cases, improve functionality, and adapt to the evolving needs of each center after June 30. By that date, all centers will be operating on a common, secure generative AI system integrated with FDA’s internal data platforms.

“There have been years of talk about AI capabilities in frameworks, conferences, and panels, but we cannot afford to keep talking. It is time to take action. The opportunity to reduce tasks that once took days to just minutes is too important to delay,” says Makary in a release.

Next Steps

Looking ahead, the FDA plans to expand generative AI capabilities across all centers using a secure, unified platform. Future enhancements will focus on improving usability, expanding document integration, and tailoring outputs to center-specific needs, while maintaining strict information security and compliance with FDA policy.

The agency-wide rollout is being coordinated by Jeremy Walsh, the FDA’s newly appointed chief AI officer and Sridhar Mantha. Walsh previously led enterprise-scale technology deployments across federal health and intelligence agencies, and Mantha recently led the Office of Business Informatics in CDER.

The agency will continue to assess performance, gather user feedback, and refine features to support the evolving needs of FDA staff and advance its public health mission. Additional details and updates on the initiative will be shared publicly in June.

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The US Food and Drug Administration (FDA) is expanding the use of unannounced inspections at foreign manufacturing facilities that produce medical products, essential medicines, and food products for American patients and consumers. 

This change builds on the agency’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program in India and China, aiming to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies, according to an FDA release.  

“For too long, foreign companies have enjoyed a double standard—given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning. That ends today. This is a key step for the FDA as part of a broader strategy to get foreign inspections back on track,” says FDA Commissioner Martin A. Makary, MD, MPH.  

The FDA will also evaluate its policies and practices for improvements to the foreign inspection program. These changes will include clarifying policies for FDA investigators to refuse travel accommodations from regulated industry, including lodging and transportation arrangements (taxi, limousine, and for-hire vehicle transit), to maintain the integrity of the oversight process.

Aligning Oversight Standards

Each year, the FDA conducts approximately 12,000 domestic inspections and 3,000 foreign inspections in more than 90 countries. While US manufacturers are subject to frequent, unannounced inspections, foreign firms have often had weeks to prepare, the FDA states. Despite the advanced notice, the FDA found serious deficiencies in foreign facilities more than twice as often as domestic facilities.  

“With this shift, the FDA is further ensuring that every product entering the US is safe, legitimate, and honestly made. Unannounced inspections will also help expose bad actors—those who falsify records or conceal violations—before they can put American lives at risk,” the FDA states in a release.

The FDA notes that it is authorized to take regulatory action against any firm that seeks to delay, deny, or limit an inspection, or refuses to permit entry for an unannounced drug or device inspection.

“The FDA’s rigorous, science-based global inspections of manufacturing facilities ensure that the food and drug products that enter the US marketplace and the homes of American consumers are safe, trusted, and accessible,” says FDA assistant commissioner for Inspections and Investigations Michael Rogers in a release. “These inspections provide real-time evidence and insights that are essential for making fact-based regulatory decisions to protect public health.”

The agency emphasized that even inspections that result in “No Action Indicated” findings provide critical regulatory intelligence, reinforcing the safety net for US consumers.

This approach represents what the FDA describes as a stronger, more proactive stance in enforcing regulatory standards for foreign manufacturers supplying the US market.

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