Use caution Medical device recall · FDA · Published September 18, 2025

HeartSine Pad-Pak Defibrillator Pads May Have Damaged Pins - Recall

HeartSine recalls Pad-Pak defibrillator pads with damaged pins that could disrupt mechanical fit and electrical contact. Check model numbers and lots for affected units.

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

🇺🇸 FDA recall #Z-0288-2026Medical device HeartSine ›

Use caution until it’s fixed

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

Take action

Contact the company

Recalling firmHeartSine Technologies Ltd207 Airport Road West · Belfast, United Kingdom

✎ GovInfoNow plain-language explainer

HeartSine is recalling specific defibrillator pad packs because customer complaints indicate some units have damaged pins that may disrupt how the pads fit and connect electrically. This could lead to improper defibrillation during emergencies. Read more at govinfonow.com/recall/51273-heartsine-pad-pak-defibrillator-pads-may-have-damaged-pins-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/51273-heartsine-pad-pak-defibrillator-pads-may-have-damaged-pins-recall · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0288-2026

Cite this page

“HeartSine Pad-Pak Defibrillator Pads May Have Damaged Pins - Recall.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51273-heartsine-pad-pak-defibrillator-pads-may-have-damaged-pins-recall. Based on FDA recall #Z-0288-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0288-2026%22&limit=1).

The FDA announced on Sept. 18, 2025, that HeartSine Technologies Ltd is recalling HeartSine Pad-Pak defibrillator pads due to potential damage pins disrupting mechanical fit and electrical contact. Owners should contact the company for a remedy.

How to tell if you have it

Brand: HeartSine
Product: HeartSine Pad-Pak
REFs: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J
Lot codes: H017-002-174, H047-002-100, H023-002-051, H017-002-173, H047-002-101, H023-002-050, H017-002-178, H017-002-071, H047-002-035, H023-002-009
UDIs: 0506016712046, 0506016712047, 0506016712123, 0506016712124, 0506016712448, 0506016712475, 0506016712476
Units affected: 1,291,165

The hazard

According to the FDA, customer complaints indicate that defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact. The agency classified this as a Class II recall.

Context

GovInfoNow's records show HeartSine Technologies Ltd has 7 other recalls on record since Feb. 1, 2023. Other recent recalls of similar products include HeartSine samaritan PAD (July 27, 2026), HeartSine 350P US Device (July 27, 2026), and HeartSine 350P, 360P, 450P Defibrillators (June 30, 2025). Other recent recalls of similar products include AVID Medical Halyard CARDIAC CATH PACK SAN23CARDQ Kit Recall (March 13, 2026) and Medline Medical Procedure Kits Recalls (May 4, 2026).

How to tell if you have this one

Check the model number on the pad pack (PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, or PAD-PAK-04J). Look for specific lot numbers and unique device identifiers (UDIs) listed in the recall notice.

Brand
HeartSine
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Numbers
Identify the model number on your pad pack (PAD-PAK-01 through PAD-PAK-04J).
Verify Lot Numbers
Check the lot numbers listed in the recall notice for affected units.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA 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,…” 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 41 days after the firm started it.

Sep 18, 2025Firm started the recall
Oct 23, 2025FDA classified it Class II
Oct 29, 2025Published in FDA’s Enforcement Report

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

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/51273-heartsine-pad-pak-defibrillator-pads-may-have-damaged-pins-recall">HeartSine Pad-Pak Defibrillator Pads May Have Damaged Pins - Recall (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-0288-2026 (September 18, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0288-2026 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.