Philips HeartStart HS1 AED Pads: Potential Gel Separation Defect
Philips is recalling adult Smart PADS cartridges for HeartStart HS1 defibrillators due to potential gel separation from the pad backing. Affected pads may have reduced gel contact, potentially affecting device performance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall affecting a critical medical device. The manufacturing defect poses a potential risk to device performance. The recall documentation does not report any associated illnesses or injuries, placing this in the risk-of-harm category without confirmed harm.
Plain-English summary
Philips North America LLC is recalling 1,696,047 adult Smart PADS cartridges (REF M5071A) for HeartStart HS1 automatic external defibrillators, affecting all manufactured lots.
The pads may experience gel separation from the foam or tin backing when peeled from the plastic liner. When this occurs, the gel may fold onto itself—reducing the surface area of contact—or may separate almost completely, leaving only a small amount of gel on the pad.
Reduced or separated gel on the pads poses a potential risk to the proper functioning of the defibrillator. The recalled products have been distributed worldwide to hospitals, medical facilities, and emergency services in numerous countries.
The recalled product
- Product
- Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
- Manufacturer
- Philips North America LLC
- Affected units
- 1,696,047
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- ALL LOTS
Distribution
Part of a larger recall action
This product is one of 2 recalled by Philips North America LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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