Lower risk Medical device recall · FDA · Published February 4, 2022

Philips Smart Pads Cartridge Recall: Gel Separation Risk in AED Pads

Philips recalls adult Smart Pads cartridges for HEARSTART HS1 defibrillators due to potential gel separation that could reduce pad effectiveness. Affected units sold since 2:00 PM on 2023-08-01.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0881-2022Medical device Philips ›

Lower-risk recall

There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad.

Take action

Contact the company

Recalling firmPhilips North America LLC22100 Bothell Everett Hwy · Bothell, WA 98021-8431

✎ GovInfoNow plain-language explainer

Philips is recalling adult Smart Pads cartridges for HEARSTART HS1 defibrillators because the gel inside may separate from the pad, reducing its effectiveness during emergencies. This could mean the device doesn't work properly if needed. Read more at govinfonow.com/recall/61179-philips-smart-pads-cartridge-recall-gel-separation-risk-in-aed.

Source Summary by GovInfoNow · govinfonow.com/recall/61179-philips-smart-pads-cartridge-recall-gel-separation-risk-in-aed · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0881-2022

Cite this page

“Philips Smart Pads Cartridge Recall: Gel Separation Risk in AED Pads.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/61179-philips-smart-pads-cartridge-recall-gel-separation-risk-in-aed. Based on FDA recall #Z-0881-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0881-2022%22&limit=1).

The FDA announced on Feb. 4, 2022, that Philips North America LLC is recalling Adult Smart PADS CARTRIDGE, REF M5071A, for use with HearStart HS1 defibrillators due to potential gel separation from the backing. This defect may reduce the pad's surface area or leave insufficient gel for effective treatment.

How to tell if you have it

Brand: Philips
Model/Reference: REF M5071A, Adult Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
Lot codes: ALL LOTS
Units affected: 1,696,047

The hazard

According to the FDA, there is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad.

Context

GovInfoNow's records show Philips North America LLC has issued 129 other recalls since July 12, 2017. Recent similar product recalls include the Medtronic GUNDRY Cannula Recall (April 21, 2026) and Philips Allura Xper FD10F Medical System Recall (Dec. 15, 2025). Other recent recalls of similar products include the Philips IQon Spectral CT Software 4.7.7.x Recall (Aug. 7, 2026) and the Philips Spectral CT 7500 Scanner recall (Aug. 18, 2026).

How to tell if you have this one

Check for Philips Smart Pads cartridges labeled 'REF M5071A' for adults, sold with HEARSTART HS1 defibrillators. All lots from 2023-08-01 are affected.

Brand
Philips
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution. US Nationwide including Puerto Rico and Guam, Germany, Australia, Sweden, Japan, Canada, Taiwan, France, Netherlands, Spain, Singapore, Austria, South Africa, Italy, United Kingdom, India, Malaysia, Switzerland, Chile, Ireland, Norway, Hong Kong, Argentina, Mexico, Bolivia, Croatia, French Guiana, Denmark, United Arab Emirates, Hungary, Belgium, Indonesia, Korea, Republic of, Bhutan, New Zealand, Bulgaria, Mauritius, Trinidad and Tobago, Israel, Guatemala, Mali, Algeria, Philippines, Malta, Curacao, Panama, Paraguay, Costa Rica, Colombia, Liechtenstein, Saudi Arabia, Monaco, Estonia, Senegal, Reunion, Luxembourg, Qatar, El Salvador, Namibia, Myanmar, Nigeria, Poland, Aruba, Greece, Martinique, Guadeloupe, Dominican Republic, China, Kosovo, Portugal, Bangladesh, Tanzania, Peru, Lithuania, New Caledonia, State of Palestine, Finland, Cambodia, Macao, Cyprus, Zambia, Viet Nam, Uruguay, Ecuador, Netherlands Antilles, Czech Republic, French Polynesia, Kenya, Cameroon, Guinea, Mayotte, and Brunei Darussalam.

Recall number	Product, codes & lots	Quantity
Z-0881-2022	Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS; ALL LOTS	1,696,047
Z-0882-2022	Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERILE, Rx only FOR USE WITH HEARSTART DEFIBRILLATORS; ALL LOTS	331,712 UNITS

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the model number REF M5071A on the cartridge label.
Contact Philips
Reach out to Philips customer service for assistance with the recall.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution. US Nationwide including Puerto Rico and Guam, Germany, Australia, Sweden, Japan, Canada, Taiwan, France, Netherlands, Spain, Singapore, Austria, South Africa, Italy, United Kingdom, India, Malaysia, Switzerland,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

Feb 4, 2022Firm started the recall
Apr 6, 2022FDA classified it Class II
Apr 13, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61179-philips-smart-pads-cartridge-recall-gel-separation-risk-in-aed">Philips Smart Pads Cartridge Recall: Gel Separation Risk in AED Pads (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0881-2022 (February 4, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0881-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.