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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices

HeartSine Pad-Pak Defibrillator Pads Recalled for Damaged Connection Pins

Agency Publication Date: October 23, 2025
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Summary

HeartSine Technologies Ltd is recalling 1,291,165 units of HeartSine Pad-Pak defibrillator pads (models PAD-PAK-01 through PAD-PAK-07). The recall was initiated following customer complaints that the connector pins on the pads may be damaged. This defect can prevent the pads from fitting correctly into the defibrillator or maintaining a stable electrical connection, which is necessary for the device to function during a cardiac emergency.

Risk

Damaged pins can disrupt the mechanical fit and electrical contact between the pads and the defibrillator. This may prevent the device from delivering life-saving electrical therapy to a patient during a medical emergency.

What You Should Do

  1. This recall affects HeartSine Pad-Pak defibrillator pads with model numbers PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, and PAD-PAK-04J.
  2. Affected products can be identified by the REF number and lot number printed on the device packaging. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled pads and contact HeartSine Technologies or your distributor to arrange for a replacement, return, or correction.
  4. Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

๐Ÿ“‹Other Action

Corrective action for medical device pins.

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: HeartSine Pad-Pak
Model / REF:
PAD-PAK-01
Lot Numbers:
H017-002-174
H047-002-100
UDI:
0506016712046

REF: PAD-PAK-01

Product: HeartSine Pad-Pak
Model / REF:
PAD-PAK-02
Lot Numbers:
H023-002-051
UDI:
0506016712047

REF: PAD-PAK-02

Product: HeartSine Pad-Pak
Model / REF:
PAD-PAK-03
Lot Numbers:
H017-002-173
H047-002-101
UDI:
0506016712123

REF: PAD-PAK-03

Product: HeartSine Pad-Pak
Model / REF:
PAD-PAK-04
Lot Numbers:
H023-002-050
UDI:
0506016712124

REF: PAD-PAK-04

Product: HeartSine Pad-Pak
Model / REF:
PAD-PAK-07
Lot Numbers:
H017-002-178
UDI:
0506016712448

REF: PAD-PAK-07

Product: HeartSine Pad-Pak
Model / REF:
PAD-PAK-03J
Lot Numbers:
H017-002-071
H047-002-035
UDI:
0506016712475

REF: PAD-PAK-03J

Product: HeartSine Pad-Pak
Model / REF:
PAD-PAK-04J
Lot Numbers:
H023-002-009
UDI:
0506016712476

REF: PAD-PAK-04J

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97651
Status: Active
Manufacturer: HeartSine Technologies Ltd
Sold By: Medical supply distributors; Authorized dealers
Manufactured In: United Kingdom
Units Affected: 1,291,165 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.