Class II U.S. Food and Drug Administration

Physio-Control, Inc. Lifepak 15 Part / Catalog Numbers / Udi-Di code: V15-7-000022 / recall: Due to required inspections not being performed on products/units that have

Recall published 1+ years ago

Due to required inspections not being performed on products/units that have gone through servicing.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Due to required inspections not being performed on products/units that have gone through servicing.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2497-2025
Published
September 10, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Physio-Control, Inc.
Product type
Medical devices
Units affected
4 units
Distribution
Nationwide
Made in
United States
Lot / code info
Part / Catalog Numbers / UDI-DI code / Serial Number: V15-7-000022 / 99577-001957 / 883873871690 / 49085553 V15-2-000051 / 99577-000046 / 883873988022 / 38154524 V15-2-000099 / 99577-000093 / 883873979020 / 39059475 V15-2-001603 / 99577-001256 / 883873911631 / 40973093
UPC codes
883873871690, 883873988022, 883873979020, 883873911631

Products covered by this recall

LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-000099 / 99577-000093 / 883873979020 V15-2-001603 / 99577-001256 / 883873911631 LIFEPAK 15: The LP15 is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.

Check your product

The notice names 7 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 883873871690
  • 883873988022
  • 883873979020
  • 883873911631

Serial number

On the rating plate, often next to the date of manufacture.

  • V15-7-000022
  • 99577-001957
  • 88387387169

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Physio-Control, Inc. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Physio-Control, Inc. — 11811 Willows Rd Ne, Redmond, WA, 98052-2003

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Physio-Control, Inc. medical devices recalled?

Due to required inspections not being performed on products/units that have gone through servicing. Due to required inspections not being performed on products/units that have gone through servicing.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 883873871690, 883873988022, 883873979020. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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