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RecallWatchMedical Device Safety
Class IIOngoingZ-0288-2026

HeartSine Technologies Ltd recalls HeartSine Pad-Pak

HeartSine Technologies LtdBelfast, United KingdomReported Oct 29, 2025 · 8 months ago
Legal News Analyst ·

Reason for recall

Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

HeartSine Pad-Pak7 codes
  • PAD-PAK-01
  • PAD-PAK-02
  • PAD-PAK-03
  • PAD-PAK-04
  • PAD-PAK-07
  • PAD-PAK-03J
  • PAD-PAK-04J

Lot / code information

Lot #
H017-002-174 and H047-002-100
UDI
0506016712046; PAD-PAK-02
Lot #
H023-002-051
UDI
0506016712047; PAD-PAK-03
Lot #
H017-002-173, H047-002-101
UDI
0506016712123; PAD-PAK-04
Lot #
H023-002-050
UDI
0506016712124; PAD-PAK-07
Lot #
H017-002-178
UDI
0506016712448; PAD-PAK-03J
Show 4 more code fields
Lot #
H017-002-071 and H047-002-035
UDI
0506016712475; PAD-PAK-04J
Lot #
H023-002-009
UDI
0506016712476

What the firm is doing

On September 18, 2025, HeartSine (Stryker) issued a "Urgent: Medical Device Recall Notification." HeartSine is asking consignees to take the following actions: 1. To ensure the device works correctly in an emergency, follow the instructions within the customer notification. A. Check the expiry date on your Pad-Pak B. Check for bent locator pins. C. Follow Pad-Paks insertion instructions. D. Submit your response online at: heartsincerecall.com. A response is required in all instances. E. Maintain Awareness F. If you have further distributed affected product(s), please forward a copy of this notice to the new responsible party and email RSRecall@stryker.com with both the location to which the product(s) was/were further distributed to and the quantity and lot number for any Pad-Paks that have been disposed of. If you have any questions or concerns, please contact Stryker Customer Service at +1 800 787 9537, option 2, from 8:00 AM to 7:00 PM (Eastern Time), Monday Friday, or HeartSine Technologies Technical Support at heartsinesupport@stryker.com.

DistributionShow details

US Nationwide distribution. Worldwide distribution to Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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