--- title: "Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARS... — FDA record Z-0881-2022 | Is It on Recall" description: "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 result" url: https://isitonrecall.com/recall/fda-device-z-0881-2022-philips-ref-m5071a-adult-smart-pads-cartridge-8-years-for-use-with-hearstart-hs1-defibrillators/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS — FDA record Z-0881-2022 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Feb 4, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS - **Reason**: 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. - **Classification**: Class II - **Recalling firm**: Philips North America LLC - **Quantity**: 1,696,047 - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0881-2022 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0881-2022%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | ALL LOTS | Match all identifying details in the current notice. A brand name alone is not enough. ## 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. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Apr 13, 2022 - **Recall initiation date**: Feb 4, 2022 - **Center classification date**: Apr 6, 2022 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0881-2022%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Philips North America Llc records](https://isitonrecall.com/brand/philips-north-america-llc/)