Replacement Kit for CHARGE-PAK battery charger 11403Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00883873824597), received between Feb 29, 2024 and Aug 25, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Component Missing” (1 report).

1 other recall cover devices cleared under the same FDA submission (P160012); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Device Sensing Problem

  The customer contacted Stryker to report that the electrodes of their device would not work. There was no patient use associated with the reported event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50432790 ↗
• MalfunctionMay 14, 2024Component Missing; Component Missing

  THE CUSTOMER REPORTED THEIR CUSTOMER REPORTED THAT THEY RECEIVED A CHARGEPACK KIT WHICH WAS MISSING THE ELECTRODES - ONLY THE BATTERY WAS IN THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19309750 ↗
• MalfunctionFeb 29, 2024Material Integrity Problem; Material Integrity Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S BAG CONTAINING THE ELECTRODES WERE DIFFICULT TO OPEN, CAUSING A DELAY IN RESUSCITATION. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18810758 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160012. One submission often covers many models, so check the product and lot details in each record.

• Z-1544-2026 · Jan 21, 2026 · Open, Classified
  PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682