CLASS II ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report

Lifepak 15, REF: 99577-000025, 99577 recalled by Physio-Control

Physio-Control is recalling Lifepak 15, REF: 99577-000025, 99577-000047, 99577-001256, distributed nationwide in the US. The recall was initiated on 13 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDevice/UDI/Serial Number: LIFEPAK 15/0088387391164815011543166573, 0088387387169015033143394891, 0088387387169015050743524360, 0088387387169015092843914574, 0088387387204815093043915122, 0088387387169016010444187447, 0088387387162116012044252611, 0088387387169016012644262721, 0088387387169016012644277082, 0088387387169016012744282280, 0088387387171316060244574340, 0088387387171316080444896329, 0088387387169016083144962804, 0088387387170617013145447229, 0088387387169017041245743786, 0088387387171317050945834209, 0088387387171317062845998142, 0088387387171317082846103043, 0088387387169017101046303288, 0088387387171317103146303092, 0088387387162117122146587130, 0088387387171317122646602003, 0088387387171317122846608783, 0088387387171317122946614788, 0088387387171318022246813507, 0088387387169018032946966267, 0088387387171318061947337396, 0088387387169018070547401928, 0088387387171318092747611441, 0088387387169018112947784931, 0088387387169018112947786317, 0088387387171318121847847661, 0088387387171318121847848950, 0088387387708118121947845317, 0088387387708118121947855371, 0088387387169018122047857172, 0088387387169018122047858660, 0088387387171318122847872868, 0088387387171319031248018370, 0088387387169019061248247559, 0088387387168319062748298704, 0088387387169019100848453060, 0088387387171319101448455890, 0088387387171319121848586351, 0088387387171319121948586599, 0088387387168320012848651507, 0088387387171320030548701689, 0088387387708120042848784975, 0088387387171320071648887706, 0088387387168320081748921846, 0088387387169020092448981398, 0088387387169020102649032288, 0088387387169020102649050140, 0088387387162120110249055931, 0088387387168320122949156402, 0088387387169021011149162067, 0088387387169021011149167463, 0088387387169021013049212578, 0088387387169021020949225869, 0088387387169021020949226060, 0088387387176821021949240566, 0088387387168321033149345530, 0088387387169021042149378981, 0088387387169021042649381781, 0088387387169021042749381576, 0088387387168321081849559854, 0088387387168321081949560127, 0088387387164521091649607224, 0088387387171321102149662806, 0088387377697122070750045009, 0088387387169022090150136719, 0088387387171322090850152289, 0088387387708122091350158293, 0088387387169022101950223934, 0088387387708122112150288760, 0088387387171322120150307353, 0088387387169023062850629377, 0088387387169023072450653772, 0088387387169023072450667197, 0088387387708123072850669746, 0088387387708123082850714419, 0088387387171323082950720588, 0088387387169023112150850129, 0088387387708123122050883524, 0088387388434824052251092313, 0088387387170624121151422867, 0088387387170624122351440213, 0088387387170624122351444039, 0088387388434824052251092313, 0088387387169019100848453060, 0088387387201715090843839264, 0088387387171318121847850793/ 38523489, 39736196, 40465345, 40717931, 40765749, 41130420, 41139184, 41420681, 41446039, 41446693, 41704583, 42221131, 42920956, 42921954, 43166573, 43394891, 43524360, 43914574, 43915122, 44187447, 44252611, 44262721, 44277082, 44282280, 44574340, 44896329, 44962804, 45447229, 45743786, 45834209, 45998142, 46103043, 46303288, 46303092, 46587130, 46602003, 46608783, 46614788, 46813507, 46966267, 47337396, 47401928, 47611441, 47784931, 47786317, 47847661, 47848950, 47845317, 47855371, 47857172, 47858660, 47872868, 48018370, 48247559, 48298704, 48453060, 48455890, 48586351, 48586599, 48651507, 48701689, 48784975, 48887706, 48921846, 48981398, 49032288, 49050140, 49055931, 49156402, 49162067, 49167463, 49212578, 49225869, 49226060, 49240566, 49345530, 49378981, 49381781, 49381576, 49559854, 49560127, 49607224, 49662806, 50045009, 50136719, 50152289, 50158293, 50223934, 50288760, 50307353, 50629377, 50653772, 50667197, 50669746, 50714419, 50720588, 50850129, 50883524, 51092313, 51422867, 51440213, 51444039, 51092313, 48453060, 43839264, 47850793, 38369584. LIFEPAK 1000/0088507469887815020943235807, 0088507469895315031343346860, 0088507469887815111944068667, 0088507469887815111944068669, 0088507469895316011844239775, 0088507469887816041444539726, 0088507469887817061745966118, 0088507469887817061745966121, 0088507469887817061745966122, 0088507469887817061745966126, 0088507469887817061945966131, 0088507469887817062945994506, 0088507469887817062946004311, 0088507469887817063046012479, 0088507469887818060547291148, 0088387381546519080648366102, 0088387381545820092948987376, 0088387381545821011249174469, 0088387381545821081349544565, 0088387381545821090249586700, 0088387381546521122249752235, 0088387381545822012649794992, 0088387381545822032949882696, 0088387381545822032949882698, 0088387381545822032949882819/ 34933095, 35096556, 35184465, 36153943, 36199099, 36560529, 36560531, 37119097, 37226402, 37330295, 38074718, 38074722, 38074727, 38074737, 38074741, 38074744, 38074745, 38074747, 38074748, 38074749, 38077938, 38077939, 38077940, 38077941, 38077944, 38378802, 38513659, 38656117, 38656121, 38656122, 38957375, 38957392, 38957397, 38957399, 38957402, 38972629, 38972677, 39775405, 39775406, 39775407, 39775415, 39964908, 40323073, 40412729, 40541187, 40584085, 40594714, 40707896, 40725568, 40725569, 40725571, 40725572, 40725575, 40725584, 40725582, 40725583, 41306695, 41692754, 41863786, 42504017, 42520778, 42803174, 42921847, 43235807, 43346860, 44068667, 44068669, 44239775, 44539726, 45966118, 45966121, 45966122, 45966126, 45966131, 45994506, 46004311, 46012479, 47291148, 48366102, 48987376, 49174469, 49544565, 49586700, 49752235, 49794992, 49882696, 49882698, 49882819. LIFEPAK 35/0088387377265224042251041190, 0088387377265224041851042010, 0088387377265224042251044581, 0088387376560924071151156570, 0088387376560924071151157072, 0088387376560924071151157449, 0088387376560924080651182632, 0088387376560924091251263526, 0088387376560924121051417585, 0088387376560925020451496956/ 51041190, 51042010, 51044581, 51156570, 51157072, 51157449, 51182632, 51263526, 51417585, 51496956. LIFEPAK 20e/0088387385386320082448935344, 0088387385386320082448935408, 0088387385386321080249537075/ 48935344, 48935408, 49537075

Quantity recalled206

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2065-2026
FDA event ID: 98418
Recalling firm: Physio-Control, Redmond, WA
Classification: Class II
Status: Ongoing
Recall initiated: 13 Apr 2026
FDA classified: 4 May 2026
Reported: 13 May 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Processing Deviation
Device type: Other Medical Devices

Timeline

13 Apr 2026	Recall initiated by company
4 May 2026	Classified by FDA	+21 days
13 May 2026	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.

The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.

Product as listed by the FDA

LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045; LIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096; LIFEPAK 35, REF: 99335-000013, 99335-000031; LIFEPAK 20e, REF: 99507-000122

Where it was distributed

US Nationwide distribution in the states of MI, WA, KY, IN, FL, NC, TX, LA, VA, NY, MA, CO, PA, OH, SC, OK, MN, WV, NJ, WI.

Nationwide Colorado Florida Indiana Kentucky Louisiana Massachusetts Michigan Minnesota North Carolina New Jersey New York Ohio Oklahoma Pennsylvania South Carolina Texas Virginia Washington Wisconsin West Virginia

Questions about this recall

Is Lifepak 15, REF: 99577-000025, 99577-000047, 99577-001256 recalled?

Yes. Physio-Control recalled Lifepak 15, REF: 99577-000025, 99577-000047, 99577-001256 on 13 Apr 2026. The recall is Class II and its status is Ongoing. Recall number Z-2065-2026.

Why was it recalled?

Which lots are affected?

Device/UDI/Serial Number: LIFEPAK 15/0088387391164815011543166573, 0088387387169015033143394891, 0088387387169015050743524360, 0088387387169015092843914574, 0088387387204815093043915122, 0088387387169016010444187447, 0088387387162116012044252611, 0088387387169016012644262721, 0088387387169016012644277082, 0088387387169016012744282280, 0088387387171316060244574340, 0088387387171316080444896329, 0088387387169016083144962804, 0088387387170617013145447229, 0088387387169017041245743786, 0088387387171317050945834209, 0088387387171317062845998142, 0088387387171317082846103043, 0088387387169017101046303288, 0088387387171317103146303092, 0088387387162117122146587130, 0088387387171317122646602003, 0088387387171317122846608783, 0088387387171317122946614788, 0088387387171318022246813507, 0088387387169018032946966267, 0088387387171318061947337396, 0088387387169018070547401928, 0088387387171318092747611441, 0088387387169018112947784931, 0088387387169018112947786317, 0088387387171318121847847661, 0088387387171318121847848950, 0088387387708118121947845317, 0088387387708118121947855371, 0088387387169018122047857172, 0088387387169018122047858660, 0088387387171318122847872868, 0088387387171319031248018370, 0088387387169019061248247559, 0088387387168319062748298704, 0088387387169019100848453060, 0088387387171319101448455890, 0088387387171319121848586351, 0088387387171319121948586599, 0088387387168320012848651507, 0088387387171320030548701689, 0088387387708120042848784975, 0088387387171320071648887706, 0088387387168320081748921846, 0088387387169020092448981398, 0088387387169020102649032288, 0088387387169020102649050140, 0088387387162120110249055931, 0088387387168320122949156402, 0088387387169021011149162067, 0088387387169021011149167463, 0088387387169021013049212578, 0088387387169021020949225869, 0088387387169021020949226060, 0088387387176821021949240566, 0088387387168321033149345530, 0088387387169021042149378981, 0088387387169021042649381781, 0088387387169021042749381576, 0088387387168321081849559854, 0088387387168321081949560127, 0088387387164521091649607224, 0088387387171321102149662806, 0088387377697122070750045009, 0088387387169022090150136719, 0088387387171322090850152289, 0088387387708122091350158293, 0088387387169022101950223934, 0088387387708122112150288760, 0088387387171322120150307353, 0088387387169023062850629377, 0088387387169023072450653772, 0088387387169023072450667197, 0088387387708123072850669746, 0088387387708123082850714419, 0088387387171323082950720588, 0088387387169023112150850129, 0088387387708123122050883524, 0088387388434824052251092313, 0088387387170624121151422867, 0088387387170624122351440213, 0088387387170624122351444039, 0088387388434824052251092313, 0088387387169019100848453060, 0088387387201715090843839264, 0088387387171318121847850793/ 38523489, 39736196, 40465345, 40717931, 40765749, 41130420, 41139184, 41420681, 41446039, 41446693, 41704583, 42221131, 42920956, 42921954, 43166573, 43394891, 43524360, 43914574, 43915122, 44187447, 44252611, 44262721, 44277082, 44282280, 44574340, 44896329, 44962804, 45447229, 45743786, 45834209, 45998142, 46103043, 46303288, 46303092, 46587130, 46602003, 46608783, 46614788, 46813507, 46966267, 47337396, 47401928, 47611441, 47784931, 47786317, 47847661, 47848950, 47845317, 47855371, 47857172, 47858660, 47872868, 48018370, 48247559, 48298704, 48453060, 48455890, 48586351, 48586599, 48651507, 48701689, 48784975, 48887706, 48921846, 48981398, 49032288, 49050140, 49055931, 49156402, 49162067, 49167463, 49212578, 49225869, 49226060, 49240566, 49345530, 49378981, 49381781, 49381576, 49559854, 49560127, 49607224, 49662806, 50045009, 50136719, 50152289, 50158293, 50223934, 50288760, 50307353, 50629377, 50653772, 50667197, 50669746, 50714419, 50720588, 50850129, 50883524, 51092313, 51422867, 51440213, 51444039, 51092313, 48453060, 43839264, 47850793, 38369584. LIFEPAK 1000/0088507469887815020943235807, 0088507469895315031343346860, 0088507469887815111944068667, 0088507469887815111944068669, 0088507469895316011844239775, 0088507469887816041444539726, 0088507469887817061745966118, 0088507469887817061745966121, 0088507469887817061745966122, 0088507469887817061745966126, 0088507469887817061945966131, 0088507469887817062945994506, 0088507469887817062946004311, 0088507469887817063046012479, 0088507469887818060547291148, 0088387381546519080648366102, 0088387381545820092948987376, 0088387381545821011249174469, 0088387381545821081349544565, 0088387381545821090249586700, 0088387381546521122249752235, 0088387381545822012649794992, 0088387381545822032949882696, 0088387381545822032949882698, 0088387381545822032949882819/ 34933095, 35096556, 35184465, 36153943, 36199099, 36560529, 36560531, 37119097, 37226402, 37330295, 38074718, 38074722, 38074727, 38074737, 38074741, 38074744, 38074745, 38074747, 38074748, 38074749, 38077938, 38077939, 38077940, 38077941, 38077944, 38378802, 38513659, 38656117, 38656121, 38656122, 38957375, 38957392, 38957397, 38957399, 38957402, 38972629, 38972677, 39775405, 39775406, 39775407, 39775415, 39964908, 40323073, 40412729, 40541187, 40584085, 40594714, 40707896, 40725568, 40725569, 40725571, 40725572, 40725575, 40725584, 40725582, 40725583, 41306695, 41692754, 41863786, 42504017, 42520778, 42803174, 42921847, 43235807, 43346860, 44068667, 44068669, 44239775, 44539726, 45966118, 45966121, 45966122, 45966126, 45966131, 45994506, 46004311, 46012479, 47291148, 48366102, 48987376, 49174469, 49544565, 49586700, 49752235, 49794992, 49882696, 49882698, 49882819. LIFEPAK 35/0088387377265224042251041190, 0088387377265224041851042010, 0088387377265224042251044581, 0088387376560924071151156570, 0088387376560924071151157072, 0088387376560924071151157449, 0088387376560924080651182632, 0088387376560924091251263526, 0088387376560924121051417585, 0088387376560925020451496956/ 51041190, 51042010, 51044581, 51156570, 51157072, 51157449, 51182632, 51263526, 51417585, 51496956. LIFEPAK 20e/0088387385386320082448935344, 0088387385386320082448935408, 0088387385386321080249537075/ 48935344, 48935408, 49537075

Where was it sold?

US Nationwide distribution in the states of MI, WA, KY, IN, FL, NC, TX, LA, VA, NY, MA, CO, PA, OH, SC, OK, MN, WV, NJ, WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Reported	Class	Recall	Company	Reason	Where
18 Mar 2026Device	CLASS II	Physio Control Infant/Child Reduced Energy Defibrillator Electrodes recalled	Physio-Control	Other	Nationwide
10 Sep 2025Device	CLASS II	Lifepak 1000 Part recalled by Physio-Control	Physio-Control	Processing Deviation	Nationwide
10 Sep 2025Device	CLASS II	Lifepak 15 Part recalled by Physio-Control	Physio-Control	Processing Deviation	Nationwide
10 Sep 2025Device	CLASS II	Lifepak CR2 Part recalled by Physio-Control	Physio-Control	Processing Deviation	Nationwide
5 Mar 2025Device	CLASS II	Lifepak 20e recalled by Physio-Control	Physio-Control	Other	WV

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