Z-1232-2025Class II

LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest

Name: Z-1232-2025 LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest
Creator: Physio-Control, Inc.
Published: 2025-02-03
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2025-02-03 / Open, Classified / root cause: manufacturing process

FDA source

Physio-Control, Inc. began a recall of LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest on 2025-02-03. FDA classified it as Class II and gives the reason as "Incorrect keypad was incorrectly installed onto a defibrillator/monitor". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1232-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-03
Posted: 2025-02-25
Recalling firm: Physio Control, Inc.
Product: LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On 02/03/2025, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via mail to a customer inform them that Stryker discovered that a keypad was incorrectly installed onto a LIFEPAK 20e defibrillator/monitor. There is a possibility that the incorrectly installed keypad may cause difficulty or the inability to actuate the keypad or buttons resulting in the inability to utilize the device. Additionally, there is a chance of water ingress or contamination resulting in damage to the internal machinery of the device. Customers are instructed to: 1. Immediately check your internal inventory to locate the product listed on the attached business reply form. 2. Please remove and quarantine the affected product from use. 3. To confirm receipt of this Medical Device Correction Notice and understanding of the provided information, please email the enclosed Business Reply Form (BRF) by January 31st, 2025 date, to [email protected]. 4. Upon receipt of the completed business reply form, Stryker will contact you to arrange for the return and replacement of your product(s). 5. 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 replacement. 6. Inform Stryker if any of the subject devices have been distributed to other organizations by contacting Stryker at: a. Device Tracking: [email protected] b. Website: https://www.strykeremergencycare.com/service-support-overview/device-registration/ For question or concerns - contact Customer Service +1 800 442 1142 or by email [email protected].
Quantity in commerce: 1
Distribution: U.S.: WV O.U.S.: N/A
Product codes and lots: Model/Catalog Number: 99507-000001 UDI-DI code: 00883873813751 Serial Number: 38289467

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1232-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1232-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-05	2025-02-25

Product code MKJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)