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U.S. Department of Health and Human Services

Class 2 Device Recall LIFEPAK 15, LIFEPAK 1000, LIFEPAK 35, LIFEPAK 20e

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 Class 2 Device Recall LIFEPAK 15, LIFEPAK 1000, LIFEPAK 35, LIFEPAK 20esee related information
Date Initiated by FirmApril 13, 2026
Date PostedMay 04, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2065-2026
Recall Event ID 98418
PMA NumberP160026 
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
ProductLIFEPAK 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
Code Information 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
FEI Number 3015876
Recalling Firm/
Manufacturer		 Physio-Control, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
For Additional Information ContactJoyce Staggs
425-867-5497
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn 04/13/2026, recall notices were sent to customers who were asked to do the following: 1) Return the business reply form by email to RSRecall@Stryker.com to confirm receipt of this notification. 2) Upon receipt of the completed business reply form, firm will contact you to arrange for corrective action on the device if service has not been performed. 3) Continue to follow the Operating Instructions and perform the daily checks and user tests. These tests can be found in the chapter "Maintaining the Equipment" subsection "General Maintenance and Testing". 4) Maintain awareness of this communication internally until all required actions have been completed within your facility. Please ensure this letter is kept with the affected device until the correction has been completed. 5) Inform firm if any of the subject devices have been distributed to other organizations. If so, provide contact details, so the firm can inform the recipients. If you have any questions or concerns, please contact the firm's Customer Service +1 800 787 9537, option 2, from 8:00 AM to 7:00 PM (Eastern Time), Monday - Friday or by email at medtechsup@stryker.com
Quantity in Commerce206
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = MKJ
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