MedTech Current regulatory intelligence and device recall publications for United States.
FDA's updated provider letter lists five models under an October 20, 2026 heading, while preserving qualified use of existing equipment and exclusions for related supplies. Import restrictions remain product- and facility-specific.
FDA's October 20 update highlights hypothetical pathways for hospital-specific sepsis models and automated ECG model retraining. The examples connect planned changes with validation, controlled deployment and continued oversight, without authorizing unrestricted learning.
FDA has finalized its approach to labeling for software distributed by drug sponsors, distinguishing FDA-required labeling from promotional labeling while retaining the separate medical-device framework.
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.
The Class II rule covers home specimen collection followed by clinical laboratory testing, not at-home result generation. Existing classification controls address the collection device, specimen-specific evidence, shipping integrity and user information.
The 9 October 2026 rule codifies a classification applicable since November 2023. Its seven groups of special controls connect sensor quality, clinical performance, alarms, usability and labelling; the device type remains subject to 510(k).
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.
Eight selected FDA Class II recalls posted from 28 September through 4 October 2026 highlight intracranial implant mislabeling, insulin-pump software failure, cardiopulmonary bypass leakage, CT imaging and radiation issues, false laboratory results, sterilization-monitoring failures, and surgical-positioner weld defects. The actions span quarantine, product return, software correction, laboratory review, destruction, replacement, and field inspection.
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.
FDA codified Class II special controls for room-temperature vascular autograft flushing and storage solutions. Six control categories govern the device type, while the original DuraGraft indication’s four-hour duration is product-specific. Developers should distinguish those two sources of requirements.
An FCC public draft proposes modernizing Part 15 UWB rules and seeks comment on a possible AI-based sensing class. Health-monitoring developers should assess device classification, emissions and measurement methods under the current framework.
OSHA has issued a preliminary finding on Intertek’s application to add UL 3100 for automated mobile platforms to its NRTL scope. The proposed expansion remains subject to a final decision.
Eight FDA Class II recall events cover pregnancy tests, respiratory and imaging systems, biopsy equipment, surgical kits, embolization devices, and bone cement. Corrective actions include component replacement, software updates, inventory controls, and product returns.
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 has issued draft recommendations for premarket submissions covering certain robotically-assisted surgical devices, including device description, non-clinical testing, software, cybersecurity, human factors, clinical data, and labeling. The draft is not for implementation, and comments are due November 24, 2026.
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.
The US FCC has opened a public comment period on specific radiofrequency exposure issues remanded in Environmental Health Trust v. FCC, while existing RF exposure limits and applicable compliance requirements remain in effect.
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.
New Mexico’s 20.13.2 NMAC requires PFAS labeling for covered products made for sale or distribution after January 1, 2027, but expressly exempts FDA-regulated medical devices, drugs, and their packaging from the rule’s specified prohibitions, reporting, testing, and labeling requirements.
Eight selected FDA Class II recalls posted from 14–19 September 2026 highlight transcatheter-device integrity, anesthesia delivery interruption, orthopaedic implant material aging, imaging-data mismatches, diagnostic measurement errors, hemodialysis handling risks, and radiotherapy software limitations. The issue emphasizes both direct clinical consequences and the operational burden of software corrections, inventory control, product returns, and user notifications.
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.
The US FDA has issued a final order denying an industry petition seeking partial 510(k) premarket notification exemptions for radiology CADe, CADx, and CADt software devices under 21 CFR Part 892.
The US FCC has issued a final rule barring equipment authorization for devices containing logic-bearing hardware components from Covered List entities, applying prospectively from October 13, 2026.
The US FDA has issued a final order codifying cardiovascular machine learning-based notification software under 21 CFR 870.2380 as Class II (special controls), establishing a 510(k) pathway while excluding arrhythmia detection.
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.
FCC has proposed a framework that would let certain unlicensed devices communicate with satellites on a non-interference basis and is seeking comment through November 9, 2026. Medical-device teams that rely on wireless modules, connected accessories, or supplier RF roadmaps should check whether the proceeding could affect future band planning, coexistence assumptions, or certification strategy.
EPA has announced the availability of a draft TSCA risk evaluation for 1,2-dichloropropane and is accepting public comments through November 3, 2026. The draft preliminarily identifies unreasonable risk to human health under certain conditions of use; it is an evaluation step, not a final restriction or ban.
Eight selected FDA Class II recall events for 30 August–5 September 2026 highlight hemodialysis blood-leak and dialysate-contamination risks, infusion-pump software, robotic-surgery motion, delayed cardiac-monitor alerts, unintended CT radiation, contaminated skin-prep components, and ophthalmic tissue-injury concerns. The actions span stop-use, quarantine, software mitigation, field correction, component removal, return, replacement, and user notification.
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.
FDA has issued two final 510(k) guidances covering dental composite resin devices and dental curing lights, replacing guidance documents from 2005 and 2006. The final versions update FDA's recommendations for device description, performance testing, and labeling, including clarified shelf-life testing for composite resins and revised radiant-power testing expectations for curing lights.
Eight selected FDA Class II recalls for 23–29 August 2026 highlight ECG waveform errors, patient-monitoring software failures, hemodialysis alarms, operating-table lock failures, loose interventional X-ray hardware, inaccurate PACS measurements, endotoxin-related surgical-kit actions, and false cleaning-indicator results. The issue emphasizes software correction, device inspection, quarantine, and field-service workload.
EPA has released a draft TSCA risk evaluation for trans-1,2-dichloroethylene, preliminarily finding that the chemical presents an unreasonable risk to human health driven primarily by certain conditions of use, and is accepting public comment through October 26, 2026. For medical-device-related manufacturers, the practical near-term question is whether the substance appears in cleaning, degreasing, formulation, or supplier processes that may later be affected by TSCA section 6 risk-management activity.
FCC has issued a correction to the July 31, 2026 final rule on Upper C-Band flexible use, correcting minor editorial errors and the stated number of years in the first and second performance benchmarks. For teams using the rule in wireless planning, certification support, or regulatory summaries, the practical task is to update internal references to the corrected text.
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.
EPA has finalized Significant New Use Rules for a batch of PMN chemicals already subject to TSCA section 5(e) Orders, with the rule taking effect on 26 October 2026. Manufacturers, importers, and processors planning a designated significant new use must submit a SNUN at least 90 days in advance and may not begin the activity until EPA completes its review and takes the actions required by its determination.
FDA is seeking public comment on extending the existing voluntary information collection used for allegations of regulatory misconduct involving medical devices and CDRH-regulated electronic products. The notice does not create new enforcement standards; it continues the existing reporting channel, under which anyone may submit allegations and may provide supporting information anonymously or with contact details.
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.
EPA has published its May 2026 TSCA Section 5 statements of findings for certain new-chemical and significant-new-use submissions determined not likely to present an unreasonable risk under the reviewed conditions of use. The notice is not a new medical-device restriction, but it can be useful upstream intelligence when suppliers introduce new polymers, additives, coatings, or other chemical inputs.
FDA has formally published Recognition List 066 in the Federal Register, covering additions, replacements, and revisions to recognized consensus standards used in medical-device premarket submissions. Manufacturers should review not only the new standard editions but also FDA recognition numbers, complete versus partial recognition, and transition deadlines for declarations of conformity.
Eight selected FDA Class II recall events for 16–22 August 2026 highlight neonatal breathing-circuit failures, erroneous diagnostic results, software-driven measurement and analyzer risks, an implant machining defect, endotoxin-related surgical-kit actions, a CT bolus-tracking issue, and high-volume urostomy pouch leakage. The issue emphasizes clinical follow-up, inventory control, result review, software correction, and component-level quality management.
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’s general draft guidance on Predetermined Change Control Plans remains in draft status, but section 515C of the FD&C Act is already in effect and manufacturers may submit PCCPs today. The draft explains what planned device modifications may be appropriate for a PCCP and the information FDA expects manufacturers to provide.
FDA has issued a discussion paper seeking feedback on how generative AI-enabled medical devices should be assessed across risk classification, premarket evaluation, and postmarket monitoring. The paper outlines possible approaches including a two-axis risk framework and competency-based premarket assessment, but it does not establish new regulatory requirements.
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.
Eight selected FDA Class II recall events for 9–15 August 2026 highlight diagnostic false negatives, interventional imaging software failures, a potential sterilization underdose, endotoxin-related kit actions, reagent rework, cryosurgical pressure risk, and an incorrect guidewire. The issue centers on clinically meaningful failures plus substantial inventory, notification, correction, and replacement work.