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HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03… recallZ-0288-2026 · HeartSine Technologies Ltd · initiated Sep 18, 2025

Class II Open, Classified All recalls posted in October 2025

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from HeartSine Technologies Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company 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 [email protected] 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 [email protected].

Recall details

Recall number
Z-0288-2026
Recall class
Class II
Status
Open, Classified
Initiated by the company
Sep 18, 2025
Posted by the FDA
Oct 23, 2025
Recalling firm
HeartSine Technologies Ltd
Quantity
1,291,165 units
Product code
MKJ
FDA submissions
P160008
Distribution
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.

Product description

HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J

Code information (models, lots, serial numbers)

PAD-PAK-01, 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, Lot: H017-002-071 and H047-002-035, UDI: 0506016712475; PAD-PAK-04J, Lot: H023-002-009, UDI: 0506016712476

Other devices under the same FDA submission

16 devices cleared under P160008 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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