Topic archive
MedTech Current publications and recall entries tagged Safety & Recalls.
FDA has classified the recall of Nova Biomedical's StatStrip Glucose Hospital Meter Systems (Gen 2.0) as Class I because retained barcode information may assign glucose results to the wrong patient or quality-control identifier.
Philips is correcting Lumify use instructions after unexpected transducer re-registration and unstable USB connections could prevent or interrupt scanning. FDA's October 19 communication confirms Class I recall status; the correction does not involve removing devices.
FDA has expanded the Class I recall involving BD Alaris Pump Infusion Sets used with the Alaris Pump Module Model 8100 after updated testing showed that some sets may perform substantially worse than previously disclosed at low flow rates and low bolus volumes.
Health Canada has classified the recall of Philips Lumify portable ultrasound systems as Type I after software-related transducer re-registration failures and unstable USB connections were found to prevent or interrupt scanning and delay patient care.
The labeled diameter guides implant selection in a neurovascular procedure. A small reported quantity does not remove the concern: the implant remains permanently in the patient. The response therefore covers unused stock and patients already treated, whose records need review to assess whether follow-up is appropriate.
Losing CGM connectivity changes how the insulin pump operates: users must manage delivery in manual mode without the app’s glucose values or automated control. For connected-device teams, the failure links release controls and sensor-compatibility testing to the ability to restore a working production version quickly.
A leak during bypass requires a response in the circuit and to the equipment supporting it. Replacing the disposable heat exchanger does not resolve contamination of the heater-cooler; that equipment also needs removal from clinical use, decontamination, and inspection.
The software failure can change radiation delivered during a scan, beyond disrupting system availability. Imaging departments must manage the affected workflow while the correction is arranged. For software-quality teams, it shows how failure to stop a scan sequence can become a radiation-control problem.
An operational analyzer can produce results that mislead clinical interpretation. Beyond calibration and discarded tests, the Medical Director must decide whether earlier results need action. Laboratory and IVD quality teams face an assay correction and a review of its clinical implications.
A no-growth result could give sterile-processing staff false reassurance that a steam cycle was effective. Affected stock must be identified and destroyed, while replacement depends on remaining shelf life. The five records belong together because they cover the same product family, failure, firm, and corrective instructions.
Image artifacts and wrong slice thickness can affect interpretation; unintended motion also concerns system behavior. Radiology, clinical engineering, and software change-control teams need the instructions for this event. It remains separate from the Bolus Tracking recall because its failure modes and corrective instructions differ.
The positioner supports the patient’s upper body and head during surgery; a failed joint can disrupt positioning. Facilities must locate and check affected devices. Continued use depends on passing the safety check. Passing devices still need exchange for an upgraded unit.
Health Canada has classified the recall of 10 specified Abiomed Automated Impella Controllers as Type I after a retrospective review found that the affected consoles had not received FCN 113 updates intended to prevent screen freezing and false controller errors during the Purge Cassette Change Wizard.
FDA has classified the recall of Draeger VentStar Resus Neo disposable breathing circuits as Class I after cracks were found in the hose, creating a risk of leakage or disconnection that may restrict ventilation or delay therapy in infants.
MHRA’s September MRI guidance update corrects diagrams and other details; the fifth-edition rewrite was introduced in July. The current guidance explains distinct questions about 7 T heating and implants, hearing-protection ratings and quench venting, rather than a single new September safety regime.
False-positive pregnancy results may affect subsequent clinical decisions. Because the affected tests appear under several brands, laboratories and distributors need to trace which configurations they supplied and ensure downstream users receive the correction notice.
Oxygen readings guide respiratory care, so affected sensors need to be identified before replacement. Clinical engineering and respiratory teams also need to coordinate with distributors on response forms and the timing of sensor changes.
Images associated with the wrong patient can mislead clinical interpretation even when the image itself is valid. Imaging and hospital IT teams should account for the Study ID risk before changing worklist, interface, or system configurations.
An interruption during breast biopsy may delay sampling or require a repeat procedure. Facilities need a workable fallback for affected systems and access for the planned software update, with clinicians informed before the next use.
Holes in the package may compromise sterility before an invasive embolization procedure. Interventional facilities need to locate the affected syringes, stop using them, and trace any stock supplied to other sites.
The same affected sponge component appears in five types of procedure kit. Hospitals therefore need to locate finished kits across specialties and remove the component as directed, while distributors pass the notice to downstream customers.
Facilities need to distinguish kits covered by the contamination update from kits affected only by the packaging-seal concern. The required response differs: some kits must be discarded, while others can be managed through quarantine and component removal.
Potential monomer leakage changes how staff handle these pre-filled cement systems. The notice calls for eye protection during operation and an immediate stop if leakage appears; the all-lot scope across four configurations also broadens inventory checks.
FDA classified Boston Scientific's Imager II Angiographic Catheter recall as Class I after reduced stabilizing agents in catheter tips were linked to tip degradation and possible detachment during use.
FDA classified Abiomed's Automated Impella Controller removal as Class I after purge-flag failures caused purge-cassette recognition problems that can delay support or require controller exchange during active support.
FDA classified BD's correction of specified dialysis convenience kits and procedure trays as Class I because they contain sodium chloride ampules affected by a separate recall over product-quality and sterility-assurance concerns.
FDA has classified the recall of specified AVID Medical convenience kits containing recalled Huons sodium chloride flush ampules as Class I because of product quality and sterility-assurance concerns affecting the saline components.
FDA has classified the recall of specified CooperSurgical INCA Infant and Neonatal Nasal CPAP sets as Class I because a loose connection between the Stay-Flex tubing and nasal cannula may cause loss of CPAP pressure and reduced oxygenation.
A structural failure involving a catheter component used during a transcatheter valve procedure can create immediate procedural disruption and retrieval concerns. The event is also relevant to cardiovascular-device manufacturers because a localized weld-control problem can trigger inventory identification and return activity across multiple clinical sites.
An unexpected transition that interrupts anesthetic-agent delivery can demand immediate clinician recognition and response during anesthesia. The event is significant to hospitals because the correction combines interim operating instructions with inspection of affected service-stock components, while manufacturers must address a nonconforming component in an installed system population.
The affected products are implanted orthopaedic components, and the FDA record links increased material oxidation to wear-related outcomes that may include pain, inflammation, and revision surgery. For manufacturers, the event also illustrates how raw-material aging controls and process-change governance can propagate across numerous implant configurations and product families.
Incorrect patient association is a data-integrity failure with direct diagnostic implications even when the underlying images themselves are unchanged. The recall is also operationally significant because healthcare organizations may need to preserve legacy systems, pause new DICOM migration work, and verify migrated studies against patient identifiers while awaiting correction.
Doppler measurements can influence vascular and hemodynamic assessment, so a mismatch between displayed and actual sample location has direct diagnostic relevance. The correction also illustrates how a software-design change can alter measurement interpretation while the device remains usable under specific interim restrictions communicated to clinical users.
Inaccurate blood-pressure measurements can affect clinical assessment and treatment decisions, especially when the error is not obvious to the user. The field action is operationally important because facilities must verify the measurement method on affected devices and temporarily standardize use around the Step Deflation setting until the product correction is available.
Hemodialysis blood tubing is part of an extracorporeal blood circuit, so connection integrity and preparation steps have direct clinical and workflow importance. The event is notable because the field action focuses on reinforcing correct use rather than removing product, placing much of the immediate burden on training, setup verification, and clinical practice.
The issue affects radiotherapy dose-checking software and can create a mismatch between calculated and delivered treatment setup if the bolus requirement is missed. Although the quantity is small, the consequence is clinically meaningful because the limitation concerns delivered dose depth.
FDA has classified the recall of specified Medtronic Bravo CF capsule delivery devices as Class I after a deployment-control problem was linked to failures of the capsule to attach to the esophagus or detach from the delivery device as intended.
Medical Action Industries is correcting specified epidural kits containing sodium chloride flush ampules subject to a sterility-related recall. FDA classified the issue as a Class I Recall, with matching CDRH records Z-3106-2026 and Z-3107-2026.
Blood-circuit leakage during hemodialysis has direct treatment and patient-safety implications and can require immediate inventory segregation across dialysis programs. The event also demonstrates why quantity aggregation must respect FDA's stated units: otherwise a seemingly simple total can introduce unsupported assumptions into an otherwise evidence-based recall summary.
Infusion-pump software behavior during syringe changes can affect medication-delivery workflow at the bedside, making the event particularly relevant to clinical engineering and medication-safety teams. The correction also depends on users following a specific compatible-syringe workflow until the underlying software behavior is addressed.
Unintended motion during orthopedic robotic procedures has obvious procedural implications and creates a high-priority field response despite the relatively small installed base. The event also distinguishes the recalled robotic-assist component from related navigation and camera equipment that the official notice permits facilities to continue using.
This event separates device sensing from downstream alert delivery: the implant may function as intended while server-side software delays the notification clinicians rely on. That makes the recall a useful example of how remote-monitoring infrastructure can create clinically meaningful risk without requiring replacement of the implanted device itself.
Dialysate concentrate is a core treatment input, so visible product contamination or discoloration requires rapid inventory control in dialysis operations. The event is also a practical example of why grouped recall entries should preserve incompatible units instead of converting or summing them in ways the FDA record does not support.
A radiation-related field correction across several CT platforms has broad relevance for imaging departments, service organizations, and device quality teams. The shared software-correction approach also makes grouping appropriate: readers can understand one underlying field action without losing the individual model families, recall numbers, or source records.
A supplier packaging defect can propagate through many downstream procedure-kit configurations, creating substantial traceability and relabeling work for hospitals and distributors. The event also illustrates an important quantity-handling edge case: an identical event total repeated across multiple FDA records should not be summed as though each were a separate quantity.
This is a labeling and technique-focused correction rather than a product-removal event, but the potential consequences involve direct ophthalmic tissue injury during cataract procedures. It is a useful reminder that field corrections may address device-design interaction with user technique even when products remain available for use under clarified instructions.
FDA has classified the recall of Boston Scientific Infinion CX Leads as Class I. The manufacturer is removing unused leads due to mechanical stress at anchor sites that may cause lead fractures and inadequate stimulation.
Incorrect ECG waveforms or heart-rate values can affect clinical interpretation and therapeutic decisions, making this a high-relevance software correction. The event also shows why manufacturers need clear interim verification steps when a software defect can alter a displayed physiological signal before a corrected version is installed.
Loss of centralized monitoring and reset alarm settings can create immediate clinical and operational consequences, especially during a software update. The event is also a strong configuration-management example: a correction can introduce risk when patient-specific or care-area alarm settings do not persist as users expect.
Hemodialysis machines support ongoing therapy, so recurring flow, water, or temperature alarms can impose immediate operational burden on clinics even when a machine remains usable without error messages. The correction also requires facilities to coordinate backup-machine use and field replacement according to each affected system's condition.
Unintended movement of an operating table during a procedure creates a direct procedural safety concern even though the affected installed base is small. The recall is also operationally significant because facilities must perform interim daily checks and locked-position verification until field service replaces the affected components with an updated design.
A mechanical issue in a ceiling-suspended interventional imaging system can interrupt procedures and requires prompt recognition of warning signs. Although only 10 systems are listed, the event is professionally relevant because it combines procedural imaging, mechanical hardware, stop-use criteria, and a service-based inspection and correction program.
Measurement accuracy is central to diagnostic imaging workflows, so even a small installed base can justify attention when software may alter a displayed measurement. The correction also illustrates a common software-field-action pattern: users may continue operating the system when they understand the limitation and apply an approved workaround.
A component-level endotoxin issue can propagate across many finished surgical-kit configurations and create substantial inventory and labeling work for healthcare organizations. The event is a useful supply-chain example because the field action focuses on identifying affected kits, controlling them in inventory, and removing the recalled component rather than discarding every complete kit.
Protein indicators are used to assess cleaning processes, so false-negative or false-positive results can undermine confidence in reprocessing verification and create unnecessary follow-up work. The event is particularly relevant to quality teams because an expired manufacturing input translated directly into performance uncertainty in a process-monitoring product.
FDA has classified the correction of AVID Medical convenience kits containing Medline Namic Star Off Handle Manifolds as Class I following reports of particulate within the fluid path, which may lead to vessel blockage, tissue ischemia, or death.
OPSS refreshed the featured recalls on its Product Recalls and Alerts page on 25 August 2026. The update is routine rather than a new recall rule, and the portal expressly excludes medicines and medical devices, which remain subject to separate MHRA safety-alert and recall channels.
FDA has classified the recall of Boston Scientific ENROUTE Transcarotid Neuroprotection System and ENROUTE Transcarotid Neuroprotection System Plus as Class I due to reports of arterial sheath tip separation during clinical use.
These circuits support neonatal and infant respiratory care, so a connector failure can create both immediate clinical-management needs and broad inventory work. The recall also illustrates how one failure mode may span several FDA product classifications and catalog families while still representing a single underlying field action.
This event directly connects assay precision to treatment decisions and makes prior-result review part of the field response.
The defect is notable because a software import can silently change laboratory calculation logic rather than producing an obvious system failure. Laboratories determine whether predefined rules were modified and whether results need retrospective review.
A machining nonconformance in an implant component can become consequential at the point of surgery, where proper screw engagement is part of fixation. The response also requires removal of affected unused product from implant sets and consignment inventory, making traceability and inventory control important beyond the manufacturing site.
Measurement errors in a diagnostic imaging workstation can affect interpretation even when source images remain available. The mitigation combines retrospective study identification, cross-checking against modality measurements, and a software update.
The event shows how one component-level nonconformance can propagate into many finished surgical-kit configurations and product classifications. For hospitals and manufacturers, the response depends on tracing affected kits, quarantining inventory, applying warning over-labels, removing the affected component before kit use, and notifying downstream customers when products were redistributed.
Bolus Tracking coordinates contrast enhancement with CT image acquisition, so failure to trigger the clinical scan can disrupt an imaging workflow at a critical step. The event also demonstrates a software correction handled under radiation-product requirements, making it relevant to both imaging-service operations and regulatory teams responsible for radiological systems.
The underlying failure is comparatively simple, but the large quantity and broad distribution create substantial inventory and replacement work. The defect requires coordinated field action and downstream notification.
FDA has classified the recall of certain Medline convenience kits containing B. Braun bupivacaine hydrochloride components as Class I. Medline Industries, LP is correcting affected kits because they include Huons Bupivacaine Hydrochloride in Dextrose Injection, USP that was recalled for quality issues.
FDA has classified the recall of specified BD Intraosseous Vascular Access System Needle Set lots as Class I after out-of-tolerance dimensions were linked to difficulty removing the obturator and potential delays in therapy; the FDA recall database lists Bard Access Systems, Inc. as the recalling firm.
False-negative molecular respiratory results can directly affect diagnostic decision-making, making this recall particularly relevant to laboratories and IVD manufacturers. The failure also shows how a reagent-manufacturing error can escape normal controls while control assays still pass, creating a significant result-integrity and quality-system lesson.
Azurion systems support image-guided interventional procedures, so software failures affecting both imaging and equipment movement can create immediate procedural and workflow consequences. Grouping the two FDA records also illustrates why product-version records with substantially identical failure modes and corrective instructions should be treated as one editorial event.
A potential sterilization underdose in products used to administer fluids into the vascular system has direct clinical and operational significance. The event also creates broad inventory work because facilities must locate specified lots across storage and use locations, discontinue affected product, and manage destruction, quarantine, replacement, and downstream notification.
This event shows how one supplier-component problem can propagate across many finished procedural kits and generate multiple FDA records. For hospitals and supply-chain teams, the operational burden extends beyond a single SKU because affected components must be identified inside kits, clinicians notified, warning labels applied, and downstream customers addressed.
This recall connects a manufacturing-process deviation directly to the reliability of a diagnostic result used in acute kidney injury assessment. It is relevant to IVD quality teams because the FDA record links the non-validated rework to potential downstream diagnostic, treatment, and monitoring consequences rather than a purely administrative nonconformity.
The event combines a physical device-design hazard with a software field correction, making it relevant to both hardware and software quality teams. Its nationwide scope and representative-installed software also create operational work for facilities while the FDA record permits continued use under existing warnings and instructions until correction.
Loss of geometry movement in an interventional fluoroscopic system can disrupt procedure workflow even when imaging remains available. The event is relevant to hospitals because the permanent correction is a future software installation, requiring users to retain and post interim instructions, recognize the failure mode, and use the specified restart process meanwhile.
An incorrect component inside a procedure kit can create a mismatch at the point of use even when the outer product identity appears correct. The event is relevant to vascular-device manufacturers and hospitals because it illustrates the importance of kit-component verification, inventory isolation, and downstream traceability for distributed procedural products.