--- title: "ACCOLADE SR SL MRI (Model L310) — FDA record Z-0081-2026 | Is It on Recall" description: "Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance" url: https://isitonrecall.com/recall/fda-device-z-0081-2026-accolade-sr-sl-mri-model-l310/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # ACCOLADE SR SL MRI (Model L310) — FDA record Z-0081-2026 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Aug 20, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: ACCOLADE SR SL MRI (Model L310) - **Reason**: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). - **Classification**: Class I - **Recalling firm**: Boston Scientific Corporation - **Quantity**: 50,135 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0081-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0081-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | GTIN 00802526558948, Serial Numbers: 701140, 701954, 702152, 702176, 702278, 702560, 702997, 702998, 703023, 703075, 703125, 703128, 703138, 703169, 703172, 703201, 703203, 703251, 703253, 703272, 703307, 703324, 703331, 703343, 703395, 703427, 703447, 703451, 703458, 703504, 703508, 703534, 703538, 703546, 703547, 703628, 703656, 703754, 703790, 703839, 704235, 704285, 704300, 704307, 704351, 704493, 704495, 704563, 704590, 704877, 705061, 705070, 705078, 705085, 705105, 705130, 705163, 705169, 705192, 705196, 705225, 705253, 705261, 705270, 705443, 705446, 705523, 705526, 705529, 705541, 705545, 705546, 705573, 705579, 705584, 705587, 705593, 705612, 706491, 707091, 707196, 707376, 707777, 708269, 708354, 709408, 709434, 709521, 709549, 709575, 709578, 709659, 709678, 709687, 709710, 709744, 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[Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0081-2026%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide No US distribution state could be established from this record. Check the official notice. ## Dates in the source - **Report date**: Oct 22, 2025 - **Recall initiation date**: Aug 20, 2025 - **Center classification date**: Oct 10, 2025 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0081-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Boston Scientific Corporation records](https://isitonrecall.com/brand/boston-scientific-corporation/)