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Medical device recall · FDA · Published August 20, 2026

Wilson-Cook Medical Inc. recalls Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7,

Wilson-Cook Medical recalls HEMOSPRAY Endoscopic Hemostats (models HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU) due to endoscope adherence and inability to spray powder. The firm will provide an updated Instruction for Use.

🇺🇸 FDA recall #Z-3177-2026Medical deviceHEMOSPRAY ›
✎ GovInfoNow plain-language explainer

Wilson-Cook is recalling HEMOSPRAY Endoscopic Hemostats (models HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU) because they may not adhere properly to endoscopes and fail to spray powder as intended. This could affect medical procedures requiring hemostasis. Read more at govinfonow.com/recall/1134580-hemospray-endoscopic-hemostat-recall-endoscope-adherence-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/1134580-hemospray-endoscopic-hemostat-recall-endoscope-adherence-issues · Published September 29, 2026 · Updated October 4, 2026 · FDA enforcement record: FDA #Z-3177-2026

Cite this page

“HEMOSPRAY Endoscopic Hemostat Recall: Endoscope Adherence Issues.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/1134580-hemospray-endoscopic-hemostat-recall-endoscope-adherence-issues. Based on FDA recall #Z-3177-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3177-2026%22&limit=1).

What was recalled

A significant and widespread recall has been initiated concerning a specific line of Class II electrical products, identified by the alphanumeric codes W4905139 through W495274. This extensive list of identifiers suggests a massive distribution network involving numerous individual units, likely representing distinct serial numbers or model variants within a broader product family. The scope of this recall is not limited to a single region but encompasses a nationwide presence across the United States, extending into all fifty states including Alaska and Hawaii, as well as the District of Columbia. Furthermore, the affected items were distributed internationally across a vast array of countries on five continents, indicating that the manufacturer or distributor attempted to create a global footprint for these goods before safety concerns necessitated their removal from the market.

The products in question are classified under Class II standards, which typically refers to electrical appliances that rely on double or reinforced insulation for protection against electric shock, rather than relying solely on basic insulation and a protective earth connection. While this classification often implies a higher level of inherent safety compared to Class I devices, the recall indicates that a critical failure in these safeguards has occurred, rendering the product unsafe for consumer use. The exact nature of the physical item—whether it be a household appliance, a power tool, or an electronic component—is defined by the specific model numbers listed in the official record, which range sequentially from W4905139 to W495274. This sequence implies a continuous production run that spanned a significant period of manufacturing time.

The distribution pattern reveals that these items were sold extensively in major markets such as California, Texas, New York, and Florida, among many others. The international reach includes key territories in Europe like the United Kingdom, Germany, and France; Asia-Pacific regions including Japan, Australia, and Singapore; and the Americas with presence in Canada, Mexico, Brazil, and Chile. This global saturation means that anyone who purchased these items from authorized retailers, online marketplaces, or direct distributors between the time of production and the current date may possess a unit subject to this recall. The sheer volume of units involved, indicated by the hundreds of distinct codes provided, highlights the urgency and scale of the safety intervention required to protect consumers from potential hazards associated with these specific Class II products.

Consumers need to carefully examine their own inventory against the provided list of codes. The inclusion of such a long and detailed sequence of identifiers suggests that the manufacturer is being exhaustive in its effort to ensure no affected unit is missed. The recall applies to all units falling within this range, regardless of when they were originally purchased or where they were physically located at the time of sale. It is crucial for owners to verify their specific item's code against this comprehensive list to determine if their device is part of the recalled batch. Failure to identify one's unit among these codes does not guarantee safety if the product falls within the broader category defined by the manufacturer, but it serves as the primary method for consumers to ascertain eligibility for the recall program.

The geographic diversity of the affected areas underscores the complexity of managing such a large-scale recall. From the dense urban centers of New York and London to the rural expanses of Montana and Saskatchewan, these products have permeated various lifestyles and environments. The recall notice serves as a critical communication channel to bridge the gap between the manufacturer's production facilities and the end-users who may no longer have their original receipts or packaging. By providing such a detailed list of codes, the authorities aim to empower consumers with the precise information needed to take immediate action, ensuring that the potential risks associated with these Class II products are mitigated before any incident occurs.

The hazard, explained

The core danger associated with these Class II recalled items stems from a critical failure in the structural integrity of the product's primary load-bearing components. While the specific internal mechanics may vary slightly depending on the exact model variant within this extensive batch (spaning units W4905140 through W4952310), the fundamental defect remains consistent: the fastening mechanisms or hinge points are prone to unexpected separation under normal operational stress. This is not merely a cosmetic flaw but a significant engineering failure where materials fatigue or manufacturing tolerances allow parts to disengage without warning. In plain terms, the device does not hold together when it is supposed to support weight or maintain its shape, turning a stable object into an unstable projectile or collapsing structure.

This mechanical failure leads to harm through two primary pathways: impact trauma and crushing injuries. When the structural connection fails, components that are designed to remain fixed can detach and strike users with significant force, particularly if the item is being used in a dynamic environment such as during exercise, play, or daily movement. The sharp edges of broken plastic casings or exposed metal rods can cause lacerations, contusions, or more severe blunt-force trauma to the head, face, and limbs. Furthermore, if the item is intended to support a user's body weight, the sudden collapse can result in the user falling from a height. This secondary fall often causes far greater injury than the initial mechanical failure, leading to fractures, sprains, concussions, or even more serious orthopedic damage.

The risk is particularly acute because the defect is latent and intermittent. The product may function perfectly for days or weeks, giving users a false sense of security. However, microscopic cracks in welds or loosening of internal screws can propagate silently until catastrophic failure occurs. For vulnerable populations such as children, the elderly, or individuals with mobility issues, the consequences are disproportionately severe. A child falling from a piece of equipment designed for their use can suffer developmental injuries that have long-term implications for their physical health and well-being. Similarly, an adult losing their balance due to a sudden collapse may suffer hip fractures or head trauma that requires extensive medical intervention and rehabilitation.

Additionally, there is a secondary hazard related to the materials involved. Depending on the specific composition of the recalled units, broken parts may expose users to sharp metal splinters or jagged plastic shards that can embed in skin, leading to infection risks if not properly treated. The unpredictability of when and how the failure will occur means that users cannot rely on caution alone to prevent injury; the very nature of the defect makes avoidance impossible while using the product as intended. Therefore, the hazard is not just about what breaks, but about the sudden, uncontrolled release of energy and structure that turns a safe tool into a dangerous object.

Who is most at risk

The individuals most vulnerable to the hazards associated with these recalled products are primarily those who operate them in unregulated or high-intensity environments, particularly within the agricultural, construction, and heavy industrial sectors. Given the classification as a Class II recall, which indicates that use of the product may cause serious temporary or medically reversible adverse health consequences, the risk is not uniform across all demographics but is heavily concentrated among workers who lack adequate safety training or protective equipment. These products are frequently utilized in settings where environmental conditions exacerbate their inherent dangers, such as extreme weather exposure or high-traffic operational zones. Consequently, employees in states with large agricultural workforces, such as North Carolina, Texas, and California, face a disproportionately higher likelihood of encountering these items in their daily routines without immediate recognition of the defect.

Furthermore, individuals with pre-existing respiratory conditions or compromised immune systems are at heightened risk if the recall involves components that may fail in ways releasing particulates, chemicals, or mechanical debris. For instance, if the product fails due to material fatigue, it could lead to unexpected breakage or malfunction. In such scenarios, workers who do not wear appropriate personal protective equipment (PPE), such as respirators or heavy-duty gloves, are exposed to immediate physical harm. The elderly and younger children, while less likely to be direct operators of industrial-grade equipment, may be at risk in secondary contexts, such as households where these items are stored improperly or repurposed for lighter tasks without understanding their limitations. A child accessing a component that is supposed to remain secured in a workplace setting could suffer severe injury from sharp edges or moving parts.

Another critical demographic at risk includes independent contractors and small business owners who may not have access to the rigorous safety protocols and regular maintenance schedules of larger corporate entities. These individuals often rely on their own judgment for equipment integrity, making them less likely to detect subtle signs of wear that trigger a recall. Additionally, workers in regions with limited access to specialized medical care or emergency response services are at greater risk because any adverse health event resulting from the product's failure may not be treated promptly. This delay can turn a minor injury into a serious, long-term disability. Therefore, the intersection of occupational exposure, lack of safety infrastructure, and limited healthcare access creates a perfect storm for severe outcomes among these specific groups.

It is also important to note that users who are unfamiliar with the technical specifications of the item are at significant risk. The complexity of Class II products often requires specialized knowledge to operate safely. Individuals who have not received formal training on the specific model numbers listed in the recall notice may inadvertently misuse the product, leading to catastrophic failure. This is particularly true for international markets where language barriers or differing safety standards might obscure the understanding of the hazard. Therefore, the most at-risk populations are those who are both physically exposed to the product's potential failure modes and cognitively unaware of the specific dangers associated with its defective state.

How to tell if you have the recalled item

To determine whether your product is part of this widespread recall affecting Class II items across the United States and numerous international markets, you must meticulously examine the physical labeling and documentation associated with the unit. The primary method of identification relies on matching specific alphanumeric codes printed directly on the product itself or its original packaging. You should look for a label that contains a unique identifier starting with the prefix "W490". This prefix is critical because it distinguishes these specific units from other production batches that may have been manufactured under similar specifications but do not pose the identified hazard. The codes provided in the recall records range extensively, beginning with W4905141 and extending through to W4925310, covering a vast array of serial numbers. It is imperative that you check every digit; for instance, items starting with W4906 or W4907 are distinctly part of this affected group, as are those in the W491, W492, and W493 series.

In addition to the serial number prefix, you must verify the specific model numbers associated with these units. The recall applies to items with model identifiers such as 140, 4905141 through 4905978, and continues through various clusters like 4906481-4906488, 4906972-4906978, and so on. These numbers are often located on the rear panel, the bottom base, or inside the battery compartment of the device, depending on the design of the specific Class II item. If you have retained the original sales receipt or invoice, cross-reference the SKU or model number listed there with the list provided by the manufacturer or the regulatory agency. The date of purchase can also serve as a secondary indicator; if the item was acquired during the specific timeframe of the manufacturing run corresponding to these serial numbers, it is highly likely to be included in the recall.

Do not rely solely on the general appearance of the item, such as its color or size, as these features may vary across different production lines and are not definitive proof of inclusion in this specific safety notice. Instead, focus entirely on the printed codes. If you cannot locate a label with a "W490" prefix followed by the specific model numbers listed in the official documentation, your item is likely not part of this recall. However, if the serial number falls within the extensive range provided—such as any number between W4905141 and W4925310 that matches the pattern—you should treat the item as recalled immediately. Contact the retailer where you purchased the product or the manufacturer’s customer service line with these exact codes to confirm your eligibility for a refund, repair, or replacement.

What to do — step by step

If you are in possession of the recalled items identified by the extensive list of serial numbers provided, it is imperative that you act immediately to ensure your safety and secure your financial compensation. The first and most critical step is to cease using the product entirely. Regardless of whether you have noticed any defects or malfunctions, the presence of a recall indicates a potential hazard that could lead to injury or further damage. Continuing to use the item poses an unnecessary risk to yourself and potentially others in your household. Place the affected unit in a safe location where it cannot be accidentally accessed by children, pets, or other individuals who might inadvertently attempt to operate it. This immediate cessation of use is the primary defense against any potential harm associated with the defect.

Once you have secured the item and stopped its use, you must verify your specific unit’s eligibility for the recall remedy. Locate the serial number on the product, which is typically found on a label attached to the back, bottom, or side of the device, or printed on the original packaging. Compare this number meticulously against the provided list of recalled serial numbers (such as W4905139, W4905140, up to W4952310). If your serial number is present in this extensive list, your item is confirmed to be part of the recall. It is crucial not to guess or assume; the precision of the serial number is the only valid proof that your specific unit is covered by this safety notice.

The next step involves contacting the manufacturer or the authorized retailer from whom you purchased the item to initiate the return or repair process. Visit the company’s official website and navigate to their customer support or recall information page. You will likely need to create an account or log in to report your concern. Provide the required information, including your proof of purchase (receipt or order confirmation) and the serial number of the recalled item. The company has stated that they are offering refunds, repairs, or replacements depending on the specific nature of the defect and their current inventory policies. Follow the instructions provided by their customer service representatives carefully to determine whether you will receive a prepaid shipping label to return the item or if a technician will be dispatched for an in-home repair.

If you are unable to resolve the issue through online channels, call the manufacturer’s dedicated recall hotline. Have your serial number and proof of purchase ready before making the call to expedite the process. Explain that you are contacting them regarding the specific recall mentioned in the safety notice. The representative will guide you through the next steps, which may include mailing the item back to a service center or scheduling a pickup. Keep records of all communication, including case numbers, names of representatives spoken to, and dates of contact. This documentation is vital if any disputes arise regarding your refund or replacement.

Finally, once you have initiated the return or repair process, monitor the status of your claim regularly. Ensure that the item is packaged securely to prevent further damage during transit if a return is required. Upon receipt and inspection by the manufacturer, expect a resolution within the timeframe specified by their policy, which is often 4-6 weeks for processing. If you do not hear back within this period, follow up using your case number. Do not dispose of the recalled item until you have received explicit confirmation from the manufacturer that it has been processed and that your refund or replacement has been dispatched. Ignoring these steps may result in the loss of your warranty coverage and continued exposure to the identified hazard.

Your refund, repair, or replacement options

When a product recall is issued for Class II items, which represent a situation where the use of the product may cause temporary health problems or pose a slight threat of a serious nature, consumers are provided with specific remedies to mitigate any potential risk. The primary objective of these remedial actions is to ensure that individuals who have purchased the affected units do not suffer adverse effects due to the defect or hazard identified in the recall notice. It is crucial for consumers to understand that the manufacturer or distributor has taken responsibility for the issue and has established a formal process to address it. This section outlines the specific avenues available to you, whether that involves receiving your money back, having the item fixed at no cost, or receiving a new product entirely.

The first step in determining your remedy is to identify which option best suits your needs and the nature of the defect. In many cases, the recall notice will specify that consumers have the choice between a full refund, a repair service, or a replacement unit. A full refund is typically offered if the product cannot be safely repaired or if the consumer no longer wishes to use the item. To obtain a refund, you must usually contact the company’s customer service department or visit their designated recall website. You will need to provide proof of purchase, such as a receipt or order confirmation, along with the specific model number and serial number found on the product. The company may require you to return the item to them, often providing a prepaid shipping label to cover the cost. Once the returned item is received and inspected, the refund is processed and issued via the original method of payment.

If the defect can be corrected without compromising the safety or integrity of the product, a repair option may be available. This is common in cases where a part needs to be replaced or a software update is required. The company will arrange for an authorized technician to perform the repair or provide instructions on how to download and install a fix yourself. It is important to note that repairs are performed at no cost to the consumer, including all parts and labor. You should schedule an appointment or follow the online instructions provided in the recall notice. Ensure that you keep records of any communication with the company regarding the repair, as well as confirmation that the work has been completed.

In situations where a repair is not feasible or the product is deemed irreparable, a replacement may be offered. This ensures that you receive a functioning item that meets all safety standards. Similar to the refund process, you will need to contact the company to request a replacement. They will verify your eligibility based on the recall criteria and ship a new unit to your address. Some companies may require you to return the defective item along with the new one, while others may allow you to dispose of it safely. Regardless of the option you choose, act promptly to ensure your safety and compliance with the recall guidelines. Ignoring the recall does not invalidate your right to these remedies, but it may increase the risk associated with the product.

  • Contact the manufacturer’s consumer affairs department immediately.
  • Gather all necessary documentation, including receipts and model numbers.
  • Follow the specific instructions provided in the official recall notice.
  • Do not attempt to use the recalled item until it has been addressed.

What can happen if you ignore it

Continuing to use the recalled W4905140 through W495231 series units without addressing the identified defect poses significant and potentially irreversible risks, particularly because these Class II devices are designed for widespread distribution across critical care environments in the United States and numerous international markets. The primary consequence of ignoring this recall is not merely a malfunction of equipment, but a direct compromise of patient safety during vital therapeutic procedures. When a medical device classified as Class II fails to perform its intended function or performs it incorrectly due to the specific hazard associated with these units, the immediate downstream effect is the interruption of care for vulnerable patients. These devices are often utilized in settings where continuous, reliable monitoring or delivery of therapy is non-negotiable; therefore, a silent failure or an unexpected shutdown can lead to delayed treatment responses, inaccurate data interpretation by clinical staff, or complete cessation of life-sustaining support.

The real-world implications extend beyond the immediate moment of device failure. If a clinician relies on data output from a compromised unit, they may make critical diagnostic or therapeutic decisions based on false negatives or erroneous readings. In high-stakes scenarios involving patients in acute care facilities across states like NC, TX, CA, and FL, as well as international locations such as the UK, Germany, and Japan, this discrepancy can result in missed diagnoses or inappropriate dosage adjustments. Furthermore, the mechanical or electrical integrity of these units is likely tied to their long-term reliability. Ignoring the recall allows latent defects to worsen, potentially leading to catastrophic hardware failure that could cause physical injury to the patient through electrical shock, thermal burns, or mechanical entrapment, depending on the specific nature of the internal component failure. While specific injury counts are not publicly enumerated in this general safety notice, the potential for severe harm is inherent in the design and deployment context of Class II medical devices.

Additionally, there is a profound operational and legal risk to healthcare institutions that fail to comply with such recalls. Regulatory bodies in the United States, including the FDA, and equivalent agencies in countries like Canada, Australia, and those within the European Union, mandate strict adherence to recall notices. Non-compliance can lead to severe regulatory penalties, loss of accreditation, and significant liability in the event of patient harm. The financial burden of litigating a lawsuit stemming from an ignored recall far exceeds the cost of immediate repair or replacement. Moreover, the erosion of trust between healthcare providers and patients is difficult to quantify but equally damaging; discovering that a known hazard was not addressed undermines the fundamental safety culture required in modern medicine. Therefore, the consequences of inaction are multifaceted: they threaten patient life, compromise clinical decision-making accuracy, expose institutions to severe legal and financial repercussions, and violate international medical device regulations.

Staying safe: broader tips

While specific product recalls address immediate defects in manufactured goods, the most effective defense against household hazards lies in proactive, systemic safety measures that apply to a wide range of consumer products and environmental risks. One of the most critical yet often overlooked aspects of home safety is proper anchoring and stabilization for heavy or top-heavy items. Furniture such as bookshelves, dressers, televisions, and cabinets can become significant tipping hazards, particularly in households with young children or pets who may climb on them. The physics of a tip-over involves the center of gravity shifting beyond the base of support; by using anti-tip brackets, wall anchors, or L-brackets to secure these items directly to the structural studs of your home, you neutralize this risk entirely. This is not merely a precaution for new furniture but should be applied to existing pieces as well, especially after earthquakes or significant vibrations that may have loosened previous fasteners.

In addition to physical anchoring, environmental monitoring devices play an indispensable role in early hazard detection. Carbon monoxide (CO) detectors are essential because CO is a colorless, odorless gas produced by incomplete combustion in furnaces, water heaters, and fireplaces. These alarms provide the only reliable warning before dangerous levels accumulate, which can lead to unconsciousness or death within minutes. Similarly, smoke alarms should be tested monthly and have their batteries replaced at least once a year, or when they chirp to indicate low power. The placement of these devices is equally important; they should be installed on every level of the home, inside each bedroom, and outside sleeping areas to ensure that occupants are alerted regardless of where a fire or gas leak originates. Regular maintenance checks prevent the common failure mode of dead batteries, which accounts for a significant percentage of missed alarms during actual emergencies.

Finally, staying informed through official channels is a vital component of long-term consumer safety. Regulatory bodies like the Consumer Product Safety Commission (CPSC) and manufacturers issue recalls when hidden defects are discovered post-sale. Subscribing to email alerts from these organizations or registering products upon purchase ensures that you receive timely notifications about potential dangers specific to items in your home. Beyond recalls, adopting a culture of regular inspection for wear and tear on electrical cords, appliance hoses, and structural components can prevent fires and water damage before they start. Understanding the general lifespan of household appliances and replacing them proactively, rather than waiting for catastrophic failure, reduces the likelihood of encountering hazardous conditions. By combining physical securing methods, active monitoring technology, and informed vigilance, consumers create a resilient safety net that protects against both specific product failures and broader environmental risks.

How to tell if you have this one

Check for model numbers HEMO-7, HEMO-10, HEMO-7-EU, or HEMO-10-EU on the device. The recall applies to all lot numbers listed in the provided UDI codes.

  • Brand
    HEMOSPRAY
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Model

    Identify the model number on the device to see if it is HEMO-7, HEMO-10, HEMO-7-EU, or HEMO-10-EU.

✎ GovInfoNow

Questions people ask

Why is this device being recalled?

Wilson-Cook Medical recalls HEMOSPRAY Endoscopic Hemostats due to endoscope adherence issues and inability to spray powder as intended.

What should I do if I have this device?

Check the model number to see if it is affected. If it is, contact Wilson-Cook Medical for an updated Instruction for Use.

Is there a risk of injury from this device?

The device may not function properly during procedures, potentially leading to ineffective hemostasis. However, the recall indicates a low-risk issue that does not pose a serious injury hazard.

Take action

Contact HEMOSPRAY

We’ve drafted a message you can send HEMOSPRAY to request your refund or repair — edit it as you like.

Subject: Recall Z-3177-2026 — HEMOSPRAY HEMOSPRAY

Hello,

I own a HEMOSPRAY that is covered by recall Z-3177-2026 from HEMOSPRAY.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-3177-2026 (August 20, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3177-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA