Recall Z-2065-2026
Physio-Control, Inc. · initiated April 13, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: 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…
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: Process control
Action taken
On 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
Details
- Recall number
- Z-2065-2026
- Initiated
- April 13, 2026
- Posted by FDA
- May 4, 2026
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 206
- Distribution
- 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.
- Recalling firm
- Physio-Control, Inc., Redmond, WA