Recall archive / FDA device enforcement

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version... — FDA record Z-1317-2025

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 Feb 13, 2025. 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: Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.
Reason: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Classification: Class II
Recalling firm: ZOLL Medical Corporation
Quantity: 56,981 units
Agency-reported status: Ongoing
Source record identifier: Z-1317-2025

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	Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO; UDI-DI: (1) 00812394021192, (2) 00812394021390; Serial Numbers: D00000003715, D00000003785, D00000003909, D00000003916, D00000003920, D00000003937, D00000003940, D00000003946, D00000003948, D00000003953, D00000003969, D00000003975, D00000004007, D00000004008, D00000004009, D00000004010, D00000004012, D00000004014, D00000004016, D00000004017, D00000004018, D00000004020, D00000004023, D00000004024, D00000004025, D00000004027, D00000004028, D00000004029, D00000004030, D00000004032, D00000004033, D00000004034, D00000004035, D00000004038, D00000004039, D00000004041, D00000004042, D00000004044, D00000004045, D00000004047, D00000004049, D00000004050, D00000004051, D00000004052, D00000004053, D00000004054, D00000004055, D00000004056, D00000004057, D00000004079, D00000004097, D00000004103, D00000004106, D00000004108, D00000004122, D00000004124, D00000004127, D00000004134, D00000004135, D00000004136, D00000004137, 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D00000007637, D00000007641, D00000007643, D00000007644, D00000007645, D00000007648, D00000007...

Label field

Details supplied by the agency

Lot, code or applicability

Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO; UDI-DI: (1) 00812394021192, (2) 00812394021390; Serial Numbers: D00000003715, D00000003785, D00000003909, D00000003916, D00000003920, D00000003937, D00000003940, D00000003946, D00000003948, D00000003953, D00000003969, D00000003975, D00000004007, D00000004008, D00000004009, D00000004010, D00000004012, D00000004014, D00000004016, D00000004017, D00000004018, D00000004020, D00000004023, D00000004024, D00000004025, D00000004027, D00000004028, D00000004029, D00000004030, D00000004032, D00000004033, D00000004034, D00000004035, D00000004038, D00000004039, D00000004041, D00000004042, D00000004044, D00000004045, D00000004047, D00000004049, D00000004050, D00000004051, D00000004052, D00000004053, D00000004054, D00000004055, D00000004056, D00000004057, D00000004079, D00000004097, D00000004103, D00000004106, D00000004108, D00000004122, D00000004124, D00000004127, D00000004134, D00000004135, D00000004136, D00000004137, D00000004139, D00000004144, 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D00000006189, D00000006190, D00000006191, D00000006192, D00000006193, D00000006194, D00000006195, D00000006196, D00000006197, D00000006198, D00000006199, D00000006200, D00000006201, D00000006202, D00000006203, D00000006204, D00000006205, D00000006206, D00000006207, D00000006208, D00000006209, D00000006210, D00000006211, D00000006212, D00000006214, D00000006215, D00000006216, D00000006217, D00000006218, D00000006219, D00000006220, D00000006221, D00000006222, D00000006223, D00000006225, D00000006226, D00000006227, D00000006228, D00000006229, D00000006230, D00000006231, D00000006232, D00000006233, D00000006234, D00000006236, D00000006237, D00000006238, D00000006239, D00000006240, D00000006242, D00000006243, D00000006245, D00000006246, D00000006247, D00000006249, D00000006250, D00000006251, D00000006252, D00000006253, D00000006254, D00000006255, D00000006256, D00000006257, D00000006258, D00000006259, D00000006260, D00000006262, D00000006263, D00000006264, D00000006265, D00000006266, 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D00000006370, D00000006371, D00000006372, D00000006373, D00000006374, D00000006375, D00000006376, D00000006377, D00000006378, D00000006379, D00000006402, D00000006412, D00000006418, D00000006420, D00000006422, D00000006424, D00000006425, D00000006426, D00000006427, D00000006428, D00000006429, D00000006430, D00000006431, D00000006432, D00000006433, D00000006435, D00000006436, D00000006437, D00000006438, D00000006439, D00000006440, D00000006444, D00000006445, D00000006446, D00000006447, D00000006449, D00000006451, D00000006452, D00000006453, D00000006454, D00000006455, D00000006456, D00000006502, D00000006504, D00000006506, D00000006507, D00000006534, D00000006536, D00000006538, D00000006539, D00000006546, D00000006554, D00000006555, D00000006578, D00000006580, D00000006587, D00000006589, D00000006591, D00000006593, D00000006595, D00000006597, D00000006602, D00000006603, D00000006605, D00000006610, D00000006616, D00000006617, D00000006618, D00000006620, D00000006622, D00000006624, D00000006636, D00000006638, D00000006640, D00000006760, D00000006768, D00000006771, D00000006773, D00000006777, D00000006788, D00000006789, D00000006790, D00000006792, D00000006793, D00000006797, D00000006799, D00000006800, D00000006801, D00000006804, D00000006805, D00000006807, D00000006809, D00000006810, D00000006811, D00000006812, D00000006814, D00000006817, D00000006818, D00000006820, D00000006821, D00000006823, D00000006825, D00000006826, D00000006832, D00000006833, D00000006834, D00000006836, D00000006843, D00000006844, D00000006845, D00000006846, D00000006885, D00000006886, D00000006965, D00000006967, D00000006969, D00000006971, D00000006972, D00000006973, D00000006978, D00000006979, D00000006981, D00000006982, D00000006983, D00000006984, D00000006985, D00000006986, D00000006987, D00000006988, D00000007000, D00000007001, D00000007003, D00000007051, D00000007056, D00000007071, D00000007092, D00000007132, D00000007133, D00000007134, D00000007136, D00000007137, D00000007140, D00000007142, D00000007144, D00000007147, D00000007148, D00000007149, D00000007151, D00000007154, D00000007155, D00000007159, D00000007167, D00000007169, D00000007170, D00000007171, D00000007172, D00000007173, D00000007174, D00000007176, D00000007177, D00000007178, D00000007179, D00000007180, D00000007181, D00000007182, D00000007183, D00000007184, D00000007185, D00000007186, D00000007187, D00000007188, D00000007189, D00000007190, D00000007191, D00000007192, D00000007193, D00000007194, D00000007195, D00000007196, D00000007197, D00000007198, D00000007199, D00000007200, D00000007201, D00000007203, D00000007204, D00000007205, D00000007206, D00000007207, D00000007208, D00000007209, D00000007210, D00000007214, D00000007215, D00000007216, D00000007217, D00000007218, D00000007220, D00000007221, D00000007222, D00000007223, D00000007224, D00000007225, D00000007226, D00000007227, D00000007228, D00000007230, D00000007231, D00000007232, D00000007233, D00000007234, D00000007235, D00000007236, D00000007240, D00000007246, D00000007247, D00000007248, D00000007250, D00000007251, D00000007253, D00000007261, D00000007268, D00000007269, D00000007274, D00000007276, D00000007280, D00000007286, D00000007287, D00000007289, D00000007291, D00000007293, D00000007297, D00000007302, D00000007305, D00000007311, D00000007312, D00000007313, D00000007314, D00000007317, D00000007322, D00000007323, D00000007324, D00000007325, D00000007326, D00000007327, D00000007328, D00000007329, D00000007330, D00000007334, D00000007337, D00000007338, D00000007339, D00000007340, D00000007343, D00000007344, D00000007345, D00000007346, D00000007347, D00000007348, D00000007350, D00000007351, D00000007353, D00000007356, D00000007358, D00000007359, D00000007361, D00000007363, D00000007365, D00000007373, D00000007375, D00000007376, D00000007378, D00000007385, D00000007386, D00000007388, D00000007391, D00000007393, D00000007394, D00000007395, D00000007396, D00000007397, D00000007398, D00000007399, D00000007401, D00000007402, D00000007403, D00000007406, D00000007407, D00000007408, D00000007409, D00000007410, D00000007412, D00000007413, D00000007414, D00000007415, D00000007416, D00000007417, D00000007418, D00000007419, D00000007420, D00000007421, D00000007422, D00000007424, D00000007425, D00000007426, D00000007427, D00000007431, D00000007432, D00000007433, D00000007435, D00000007436, D00000007437, D00000007438, D00000007440, D00000007444, D00000007446, D00000007460, D00000007467, D00000007471, D00000007472, D00000007473, D00000007475, D00000007477, D00000007478, D00000007479, D00000007483, D00000007484, D00000007507, D00000007510, D00000007529, D00000007531, D00000007534, D00000007536, D00000007539, D00000007540, D00000007541, D00000007542, D00000007543, D00000007549, D00000007558, D00000007572, D00000007606, D00000007611, D00000007614, D00000007620, D00000007624, D00000007625, D00000007627, D00000007629, D00000007630, D00000007631, D00000007634, D00000007636, D00000007637, D00000007641, D00000007643, D00000007644, D00000007645, D00000007648, D00000007...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

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

Distribution

Domestic: Nationwide Distribution International: AE, AI, AM, AR, AT, AU, BD, BE, BG, BH, BM, BN, BS, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, EG, ES, FI, FR, GB, GH, GU, HK, HR, HU, ID, IE, IL, IN, IS, IT, JE, JM, JP, KR, KW, KZ, LB, LT, MA, MC, MD, ME, MQ, MS, MT, MX, MY, NC, NG, NL, NO, NZ, OM, PA, PE, PG, PH, PK, PL, PR, PT, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, SM, TC, TH, TN, TR, TW, UA, US, VG, ZA.

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: Mar 19, 2025
Recall initiation date: Feb 13, 2025
Center classification date: Mar 12, 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 the record says

Lot and product identifiers

Distribution

Dates in the source

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