What was recalled
The U.S. Food and Drug Administration (FDA) has issued a Class II recall involving a specific surgical device manufactured by Stryker under the Ethicon brand. The item at the center of this notice is the REF:2B5ST XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE, which measures 5MM x 75MM. This particular model is a reusable access port system designed for use in minimally invasive surgical procedures. It is important to note that this recall applies exclusively to this specific reference number and configuration; other models or sizes within the XCEL line are not included in this announcement unless explicitly listed.
The scope of the distribution was extensive, covering a nationwide presence across the United States and extending into international markets. Within the U.S., the device was distributed to medical facilities in all 50 states, including Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, the District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming. Additionally, the product reached patients and healthcare providers in Canada and Israel. While the recall is federal, this specific alert originates from Arizona, indicating where the incident or reporting may have been initially documented.
To identify if a unit is affected, you must look at the Unique Device Identifier (UDI) and the lot numbers printed on the packaging or device itself. The UDI for the recalled batch is (01)00885825017231. The recall encompasses devices from the following specific lots: 16188647, 16210212, 16243934, 16267300, 16285639, 16285656, 16306188, 16306231, 16364978, 16470903, 16521533, 16547722, 16580202, 16599810, 16637989, 16656930, 16665550, 17005619, 17069758, 17113276, 17117460, and 17146892. If your facility or patient has a device with this UDI and any of the listed lot numbers, it falls under this recall.
The recall was officially announced on August 19, 2026. This date marks when the FDA published the notice, signaling that the manufacturer or the agency has identified a potential safety issue requiring corrective action. As a Class II recall, this indicates a moderate risk level where use of the product could cause temporary health problems or pose a slight threat of serious harm, but is not expected to cause death. However, because this device is used in surgical settings, any malfunction can have immediate clinical consequences, which is why precise identification and prompt action are critical.
The hazard, explained
To understand why this recall matters, it helps to look at what the device is actually doing inside the body during a laparoscopic procedure. The Stryker XCEL Bladeless Trocar with Optiview Technology is an access port system designed to create a sealed entry point for surgical instruments and cameras. Think of it as a specialized valve that allows surgeons to insert tools into the abdominal cavity while maintaining pressure, which is critical for keeping the area inflated and visible. The device relies on precise mechanical integrity to withstand the forces applied by surgeons manipulating instruments and the internal pressure of the patient’s abdomen.
The core issue identified in this recall is that the reusable access port system may crack or separate during use. This is not a minor cosmetic flaw; it is a structural failure. When a trocar cracks, the continuous seal that protects the patient is compromised. When it separates, the device physically breaks apart into pieces. In a high-pressure environment like an inflated abdomen, this loss of integrity can lead to several serious complications. For instance, if the seal fails, gas used to inflate the cavity can leak out, potentially collapsing the surgical field and forcing the procedure to be aborted or converted to open surgery. More critically, if parts of the device separate, they remain inside the patient.
If a piece of the cracked plastic or metal component breaks off and stays in the body, it becomes a foreign object that can cause significant tissue damage, infection, or bleeding. This is particularly dangerous because trocars are inserted directly through the abdominal wall into sensitive areas near major blood vessels and organs. A separated fragment could puncture these structures, leading to internal hemorrhage or injury to the intestines or other viscera. Even if the pieces do not cause immediate perforation, they can migrate or cause chronic inflammation, requiring additional surgeries to locate and remove the debris.
Additionally, the crack itself creates a pathway for bacteria. Surgical instruments pass through this port repeatedly. If the device is cracked, microbes from the outside environment or from the instruments themselves can bypass the sterile barrier and enter the peritoneal cavity. This significantly increases the risk of post-operative infections, which can range from superficial site infections to life-threatening sepsis. The combination of physical trauma from broken pieces and the heightened risk of infection makes this a Class II recall, indicating that use of the product could cause serious adverse health consequences or death.
- Structural Failure: The device breaks under normal surgical stress, losing its ability to hold pressure.
- Retained Fragments: Broken pieces may remain inside the patient, requiring removal surgery.
- Infection Risk: Cracks allow bacteria to bypass sterile seals and enter the body cavity.
Who is most at risk
When evaluating who might be affected by this recall, it is important to first understand the specific context of the product involved. The Stryker Sustainability Solutions recall concerns the REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM. This is not a consumer good found in a household kitchen or a garage; it is a specialized medical device designed for use in clinical settings. Therefore, the primary group at risk is not the general public, but rather healthcare professionals who handle, set up, or operate this equipment during surgical procedures. The individuals most directly exposed to the potential hazard of the reusable access port system cracking or separating are the surgeons, nurses, and sterile processing technicians who interact with the trocar in operating rooms across the United States, as well as in Israel and Canada.
The risk is further defined by the distribution pattern of these specific units. According to the FDA notice, this recall covers devices distributed nationwide within all 50 states, including the District of Columbia and Puerto Rico, with additional distribution to international partners in Israel and Canada. Consequently, any medical facility in these regions that has received lots ending in numbers such as 16188647, 16210212, or 16599810 holds a potential liability. The people most at risk are those working in hospitals, ambulatory surgical centers, and clinics within these jurisdictions that have not yet identified and quarantined the affected inventory. Since the device is classified as a Class II recall, the potential for serious injury exists if the device fails during use, making the identification of these specific healthcare workers crucial.
In terms of patient vulnerability, the risk falls on individuals undergoing endoscopic or laparoscopic surgeries where this specific trocar was utilized. Patients who have recently undergone procedures using the XCEL BLADELESS TROCAR with the listed lot numbers are the ones whose safety is directly compromised by the mechanical failure described. While the recall does not specify that any injuries have already occurred, the nature of the hazard—a crack or separation during use—poses a significant threat to patients who rely on the integrity of the access port for safe surgical entry. These patients may be particularly vulnerable if the device fails mid-procedure, potentially leading to complications such as loss of pneumoperitoneum, instrument malfunction, or unintended tissue damage.
It is also worth noting that while this recall does not explicitly mention children or the elderly as distinct demographic groups, the physiological differences in patient anatomy can influence risk. For instance, patients with smaller body habitus or those requiring precise access due to complex medical histories may be more susceptible to the consequences of a device failure. However, the overarching factor remains the use of the specific recalled lots in a clinical setting. Therefore, the most at-risk population is strictly limited to patients treated at facilities that distributed these units and the medical staff who used them, rather than any broad demographic group in the general community.
How to tell if you have the recalled item
If you are a healthcare professional or work in a surgical facility, identifying whether your inventory contains the affected Stryker product requires careful attention to specific labeling details. Because this recall involves a specialized medical device used in laparoscopic surgery, general descriptions are not enough. You must verify the exact reference number, lot numbers, and Unique Device Identifier (UDI) to confirm if a unit is part of this safety notice. The primary product under recall is the REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR with OptiView Technology & Sleeve, specifically in the 5MM x 75MM size configuration. This is a reusable access port system designed for minimally invasive procedures, and its identification relies on precise manufacturing codes rather than just the brand name.
To determine if you have this recalled item, start by examining the packaging and the device label itself. Look for the Reference Number (REF), which must match 2B5ST exactly. Next, check the lot numbers printed on the package or the device. The recall applies to a wide range of specific lots. You need to cross-reference your inventory against the following list: 16188647, 16210212, 16243934, 16267300, 16285639, 16285656, 16306188, 16306231, 16364978, 16470903, 16521533, 16547722, 16580202, 16599810, 16637989, 16656930, 16665550, 17005619, 17069758, 17113276, 17117460, and 17146892. If your device carries any of these lot numbers, it is included in the recall.
Additionally, you should verify the Unique Device Identifier (UDI). The UDI for this recalled product begins with (01)00885825017231. This code is critical for confirming the specific model and manufacturer. While the device was distributed nationwide across all 50 states, the District of Columbia, Puerto Rico, as well as in Canada and Israel, the physical location where you purchased it does not change the identification criteria. Whether the device came from a major U.S. distributor or a local medical supply store, the identifying marks on the product itself are what matter. If you cannot find the lot number or UDI clearly printed on the packaging, or if the REF number differs from 2B5ST, your device is likely not part of this specific recall notice. However, when in doubt, it is always safest to contact Stryker Sustainability Solutions directly for confirmation.
- Brand: Stryker (Ethicon Endo-Surgery, Inc.)
- Product Name: XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE
- Reference Number: 2B5ST
- Size: 5MM x 75MM
- UDI: (01)00885825017231
- Affected Lots: See list above
What to do — step by step
If you are a healthcare provider or facility that has received the Stryker Sustainability Solutions product identified as REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM, your immediate priority must be patient safety and strict adherence to regulatory protocols. The U.S. Food and Drug Administration (FDA) has classified this recall as a Class II event, which indicates that use of the product may cause temporary health problems or pose a slight threat of a serious nature if exposure is not corrected. Because the specific remedy for this recall has not been explicitly stated in the current public notices, you must act with caution and assume that any continued use poses an unacceptable risk until you receive direct guidance from Stryker.
First and foremost, you must immediately stop using the affected devices. The core hazard identified is that the reusable access port system may crack or separate during surgical procedures. In a clinical setting, such a failure can compromise the integrity of the sterile field, lead to loss of pneumoperitoneum, or cause unintended tissue injury. Do not attempt to repair the device yourself, as this is a complex medical instrument requiring manufacturer-level engineering oversight. Quarantine any remaining stock in your inventory right away. Place these items in a secure, clearly labeled area that is physically separated from other surgical supplies to prevent accidental re-use by staff who may not be aware of the recall status.
Next, you need to verify exactly which units are affected. While the recall affects a wide distribution pattern across the United States, including all 50 states and territories like Puerto Rico, as well as Canada and Israel, your specific liability is limited to the lots you hold. Check your inventory records against the following lot numbers: 16188647, 16210212, 16243934, 16267300, 16285639, 16285656, 16306188, 16306231, 16364978, 16470903, 16521533, 16547722, 16580202, 16599810, 16637989, 16656930, 16665550, 17005619, 17069758, 17113276, 17117460, and 17146892. If your stock matches any of these numbers, they are part of the recall batch.
Since the official remedy is not yet detailed in the public report, you must contact Stryker directly to determine the next steps. They will likely instruct you on whether to return the devices for destruction, repair, or replacement. Follow their instructions precisely. If you have already used a device from these lots and a patient experienced an adverse event, you are required to report this to the FDA’s MedWatch program. Document every detail of the incident and retain all physical evidence of the device if possible, as this information is critical for the ongoing investigation. Until Stryker provides a clear remedy, treat all units with extreme caution and do not introduce them into any surgical workflow.
Your refund, repair, or replacement options
When a medical device recall occurs, the most pressing question for healthcare providers and patients alike is often what happens next regarding the physical product itself. In this specific instance involving Stryker Sustainability Solutions and the Ethicon Endo-Surgery XCEL Bladeless Trocar with OptiView Technology & Sleeve (Reference Number 2B5ST), the recall notice presents a unique situation regarding remedies. According to the official FDA record dated August 19, 2026, a specific remedy such as a refund, repair, or replacement is not currently stated. This absence of explicit remediation instructions in the initial filing can understandably cause confusion, but it does not mean that action is unnecessary. Instead, it indicates that the standard process for handling recalled medical devices must be followed through direct communication with the manufacturer.
Because the official documentation does not list a standardized refund or exchange program at this time, your primary course of action must involve contacting Stryker directly. Manufacturers are legally required to manage the logistics of recalled Class II devices, which include ensuring that defective units are removed from use and accounted for. The lack of a pre-written remedy in the public notice suggests that individual cases may need to be evaluated based on inventory status, lot numbers, and the specific circumstances of the distribution. Therefore, you should not assume that no action is required simply because a refund policy isn't explicitly detailed in the summary.
If you are a healthcare facility or surgeon who possesses this device, do not attempt to use it under any circumstances. The hazard involves the reusable access port system potentially cracking or separating during use, which poses a direct risk to patient safety. Instead, immediately isolate any units associated with the listed lots (such as 16188647, 16210212, 16243934, and others up to 17389157) from your active inventory. Contact Stryker’s customer service or medical device reporting line to inquire about their specific return procedures. They will likely provide instructions on how to ship the devices back for destruction or inspection, which is the standard industry practice for hardware recalls where structural integrity has been compromised.
For patients who may have undergone a procedure using these trocars, it is important to understand that you typically do not handle the device directly. The remedy in this context is managed entirely between the manufacturer and the healthcare provider. However, if you are concerned about your personal health outcome, you should consult with your surgeon or care team. They can verify whether the specific device used in your procedure was part of the recalled lots by checking their records. While a direct financial refund to the patient is not typical for surgical devices (as the cost is usually absorbed by the hospital or insurance), the priority remains ensuring that no further units are used and that any potential adverse events are reported to the FDA’s MedWatch program. The manufacturer will handle the logistical remedy, which generally involves the retrieval and destruction of the unsafe stock rather than a monetary exchange.
What can happen if you ignore it
When a medical device is recalled due to a structural integrity issue, the decision to continue using the product or ignoring the notification is not merely an administrative oversight—it introduces significant and unnecessary risk into a clinical environment. In the case of the Stryker Sustainability Solutions recall involving the REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL Bladeless Trocar with Optiview Technology & Sleeve, the core hazard is that the reusable access port system may crack or separate during use. This is a critical failure mode because trocars serve as the primary gateway for surgeons to insert instruments into the patient’s body during laparoscopic and other minimally invasive procedures. When this pathway compromises, the consequences can cascade rapidly, affecting both patient safety and procedural outcomes.
The most immediate danger of ignoring this recall is the potential for a breach in the sterile field or loss of pneumoperitoneum. If the trocar cracks or separates while it is inserted into the patient, gas used to inflate the abdominal cavity for visibility may escape. This can cause the surgical site to collapse unexpectedly, forcing the surgeon to stop mid-procedure. In a worst-case scenario, if the separation occurs near vital structures such as blood vessels or organs, the crack could lead to unintended tissue damage or bleeding. While the recall facts provided do not list specific reported injuries or incidents at this time, the nature of the defect—a mechanical failure under stress—means that any use carries a latent risk of traumatic injury to the patient. The device is designed to maintain a seal; when that seal fails due to cracking, that protective barrier disappears.
Beyond the immediate physical risks to the patient, ignoring the recall creates serious operational and legal liabilities for healthcare providers and facilities. Medical devices are cleared based on their performance under specific conditions. Using a known defective component violates standard of care protocols and institutional safety policies. If a complication arises from using a recalled unit, the facility could face severe regulatory scrutiny from the FDA, potential malpractice liability, and loss of trust from patients. Furthermore, because the defect involves cracking or separation, there is a risk that fragments of the device could remain within the patient’s body if the component breaks apart during removal or while in situ. Retrieving such fragments often requires additional invasive surgery, extending recovery time and increasing the risk of infection.
It is also important to consider the reliability of the Optiview Technology integrated into this specific trocar. This technology provides real-time visualization of tissue layers as the instrument advances. If the housing cracks or the sleeve separates, the visual feedback may become distorted or unreliable, leading to misjudgment during insertion. This can result in blind advancement of other instruments through compromised tissue planes. The uncertainty introduced by a malfunctioning device undermines the precision that minimally invasive surgery is meant to provide. Therefore, the consequence of ignoring this recall is not just a theoretical possibility of harm; it is an active degradation of surgical safety, patient outcome quality, and institutional integrity. The only way to eliminate these compounded risks is to immediately remove the affected lots from service.
Staying safe: broader tips
While this specific recall highlights a manufacturing defect in a specialized medical instrument, the underlying principle of safety applies to any complex device you rely on for your health or home. The most powerful tool you have against product failures is proactive awareness. Government agencies like the FDA and the Consumer Product Safety Commission (CPSC) publish regular alerts, but waiting for a headline can sometimes feel too late. Instead, make it a habit to register your high-value or safety-critical purchases immediately after buying them. Manufacturers often use these registration forms not just for warranty purposes, but as the primary channel to notify owners of recalls, software updates, or component failures. By keeping your contact information current with these companies, you ensure that if a potential issue arises in the future, you are among the first to know, allowing you to act before any harm occurs.
Beyond registration, familiarize yourself with the basic maintenance and inspection requirements outlined in the user manuals for your devices. For medical equipment, this might mean checking seals, ports, or batteries for wear and tear that mimics the cracks or separations seen in defective units. For home safety items like smoke detectors or carbon monoxide alarms, regular testing is non-negotiable. These devices are designed to fail safely, but only if they are maintained according to schedule. If you notice any unusual sounds, visual damage, or operational glitches in any critical device, do not assume it is a minor glitch. Trust your instincts and consult the manufacturer’s support resources immediately. Ignoring early warning signs can turn a manageable issue into a hazardous situation.
It is also helpful to understand the classification systems used by regulators. A Class II recall, for instance, indicates a situation where use of the product might cause serious health consequences or death, but where there is a reasonable probability that the hazard will not result in such consequences if the remedy is followed. Knowing this context helps you prioritize your response without falling into panic. Stay informed by subscribing to official government safety newsletters or following verified social media accounts of regulatory bodies. This general vigilance creates a layer of protection that extends far beyond any single recall, ensuring that you remain prepared for whatever safety challenges may arise in the future.