Recall archive / FDA device enforcement

Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, M... — FDA record Z-0051-2025

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 2, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
Reason: Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.
Classification: Class II
Recalling firm: AURIS HEALTH INC
Quantity: 176
Agency-reported status: Ongoing
Source record identifier: Z-0051-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Cart Power Cord 20' 14AWG BLK, PN 304-003613-00. Tower Power Cord 20' 14AWG BLK, PN 304-003607-00. REF/UDI-DI/Serial Numbers: MON-000005-01/+B634MON000005010/110024, 13, 110014, 110016, 110040, 110038, 110027, 110035, 110022, 110034, 1806P2, 120170, 110045, 110039, 110049, 110047, 110052, 110030, 110032, 110021, 110043, 110050, 110029, 110033, 110046, 110048, 110018, 110015, 110051, 1806P1, 110012, 14, 110041, 110036; MON-000005-01R/+B634MON00000501R0/110020, 110017, 110031, 110028, 120042, 110013. MON-000006/+B634MON0000060/120088, 120057, 120046, 120058, 120121, 120152, 120015, 120160, 120068, 120167, 120025, 120030, 120044, 120093, 120040, 120063, 120092, 120173, 120036, 120064, 120122, 120056, 120128, 120017, 120089, 120075, 120031, 120169, 120113, 120168, 120055, 120148, 120014, 120060, 120124, 120164, 120123, 120007, 120006, 120004, 120120, 120126, 120082, 120047, 120051, 120020, 120103, 120153, 120108, 120037, 120074, 120005, 120130, 120095, 120096, 120009, 120111, 120022, 120054, 120163, 120027, 120090, 120141, 120072, 120155, 120101, 120143, 120125, 120052, 120100, 120050, 120098, 120045, 120131, 120013, 120105, 120165, 120136, 120029, 120041, 120139, 120137, 120053, 120028, 120034, 120085, 120019, 120049, 120209, 120144, 120161, 120001, 120145, 120127, 120011, 120070, 120076, 120134, 120117, 120077, 120149, 120102, 120002, 120010, 120003, 120023, 120146, 120043, 120071, 120107, 120065, 120116, 120150, 120066, 120166, 120033, 120079, 120008, 120132, 120086, 120032, 120073, 120016, 120080, 120078, 120012, 120084, 120083, 120038, 120067, 120021; MON-000006-RFB/+B634MON0000060/120081, 120026, 120091, 120106, 120104.

Label field

Details supplied by the agency

Lot, code or applicability

Cart Power Cord 20' 14AWG BLK, PN 304-003613-00. Tower Power Cord 20' 14AWG BLK, PN 304-003607-00. REF/UDI-DI/Serial Numbers: MON-000005-01/+B634MON000005010/110024, 13, 110014, 110016, 110040, 110038, 110027, 110035, 110022, 110034, 1806P2, 120170, 110045, 110039, 110049, 110047, 110052, 110030, 110032, 110021, 110043, 110050, 110029, 110033, 110046, 110048, 110018, 110015, 110051, 1806P1, 110012, 14, 110041, 110036; MON-000005-01R/+B634MON00000501R0/110020, 110017, 110031, 110028, 120042, 110013. MON-000006/+B634MON0000060/120088, 120057, 120046, 120058, 120121, 120152, 120015, 120160, 120068, 120167, 120025, 120030, 120044, 120093, 120040, 120063, 120092, 120173, 120036, 120064, 120122, 120056, 120128, 120017, 120089, 120075, 120031, 120169, 120113, 120168, 120055, 120148, 120014, 120060, 120124, 120164, 120123, 120007, 120006, 120004, 120120, 120126, 120082, 120047, 120051, 120020, 120103, 120153, 120108, 120037, 120074, 120005, 120130, 120095, 120096, 120009, 120111, 120022, 120054, 120163, 120027, 120090, 120141, 120072, 120155, 120101, 120143, 120125, 120052, 120100, 120050, 120098, 120045, 120131, 120013, 120105, 120165, 120136, 120029, 120041, 120139, 120137, 120053, 120028, 120034, 120085, 120019, 120049, 120209, 120144, 120161, 120001, 120145, 120127, 120011, 120070, 120076, 120134, 120117, 120077, 120149, 120102, 120002, 120010, 120003, 120023, 120146, 120043, 120071, 120107, 120065, 120116, 120150, 120066, 120166, 120033, 120079, 120008, 120132, 120086, 120032, 120073, 120016, 120080, 120078, 120012, 120084, 120083, 120038, 120067, 120021; MON-000006-RFB/+B634MON0000060/120081, 120026, 120091, 120106, 120104.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide - US Nationwide distribution including in the states of MN, FL, NC, AK, NJ, NY, VA, WI, AZ, MS, LA, MI, MA, MT, WV, GA, DE, TX, CA, OH, IN, SC, PA, CT, ND, MO, DC, IL, NE, ID, WA, TN, OR, AL, SD, CO, KY, NM, VT, MD and the countries of Canada.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Oct 16, 2024
Recall initiation date: Aug 2, 2024
Center classification date: Oct 10, 2024

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 the record says

Lot and product identifiers

Distribution

Dates in the source

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