Class II U.S. Food and Drug Administration

HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes recall: Due to a damaged (over stretched) membrane tail that causes an intermittent

Recall published last month

Due to a damaged (over stretched) membrane tail that causes an intermittent fault.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Due to a damaged (over stretched) membrane tail that causes an intermittent fault.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-3120-2026
Published
September 16, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
HeartSine Technologies Ltd
Product type
Medical devices
Units affected
11,912
Distribution
Nationwide
Made in
United Kingdom
Lot / code info
350P US Device, US English - 2 Min CPR Item code: 350-STR-US-10 UDI-DI codes: 0506016712067 Serial Numbers: 22D91164357L22 22D91164989L22 22D91180808K23 23D98000415K23 23D98000597K23 23D98001134L23 23D98001634I23 23D98001722F23 23D98002004K23 23D98002054K23 23D98002059I23 23D98002086L23 23D98002225K23 23D98002639K23 23D98002649K23 23D98002771L23 23D98002897K23 23D98003187A24 23D98003188L23 23D98003198F23 23D98003221K23 23D98003523K23 23D98004710K23 23D98004956L23 23D98005238E23 23D98005242K23 23D98008495L23 23D98008520K23 23D98008591K23 23D98008832K23 23D98008910E23 23D98009571F23 23D98009597F23 23D98009629I23 23D98009835L23 23D98009905F23 23D98010830K23 23D98012539K23 23D98012748G23 23D98013452K23 23D98013684F23 23D98014324L23 23D98014750K23 23D98014988K23 23D98015098K23 23D98015120K23 23D98015207K23 23D98015221K23 23D98015222K23 23D98015231L23 23D98015571F23 23D98016139F23 23D98016168K23 23D98016187F23 23D98016436K23 23D98016463F23 23D98016490L23 23D98016718K23 23D98016725K23 23D98017989L23 23D98018269K23 23D98018271K23 23D98018272J23 23D98018274J23 23D98018277J23 23D98018280K23 23D98018284J23 23D98018285K23 23D98018286J23 23D98018287J23 23D98018290K23 23D98018291K23 23D98018292J23 23D98018294F23 23D98020005K23 23D98023298L23 23D98024058K23 23D98024075K23 23D98100344K23 23D98100567I23 23D98100620L23 23D98100627I23 23D98102225K23 23D98102340K23 23D98102422K23 23D98102666L23 23D98103547K23 23D98103822J23 23D98103971J23 23D98103972K23 23D98103973J23 23D98103974J23 23D98103975J23 23D98103976J23 23D98103977J23 23D98103979J23 23D98103980J23 23D98103981J23 23D98103982J23 23D98103983J23 23D98103984J23 23D98103985J23 23D98103988J23 23D98103989J23 23D98103990J23 23D98103991L23 23D98103992J23 23D98103993J23 23D98103994J23 23D98103995J23 23D98104017L23 23D98104195J23 23D98104196J23 23D98104197K23 23D98104198J23 23D98104199J23 23D98104231J23 23D98104232K23 23D98104234J23 23D98104235J23 23D98104236K23 23D98104237J23 23D98104238J23 23D98104239J23 23D98104240J23 23D98104243J23 23D98104244J23 23D98104245J23 23D98104246J23 23D98104247J23 23D98104249J23 23D98104250J23 23D98104251J23 23D98104252J23 23D98104253J23 23D98104254J23 23D98104256J23 23D98104257J23 23D98104258J23 23D98104259J23 23D98104260J23 23D98104261J23 23D98104262J23 23D98104263J23 23D98104264J23 23D98104265J23 23D98104266J23 23D98104267J23 23D98104268J23 23D98104269J23 23D98104270J23 23D98104272J23 23D98104273J23 23D98104274J23 23D98104275J23 23D98104276J23 23D98104277J23 23D98104278J23 23D98104279J23 23D98104286J23 23D98104292L23 23D98104310K23 23D98104315J23 23D98104327K23 23D98104543J23 23D98104544J23 23D98104545J23 23D98104546J23 23D98104547J23 23D98104548J23 23D98104549J23 23D98104551J23 23D98104553J23 23D98104555J23 23D98104556J23 23D98104557J23 23D98104558J23 23D98104561J23 23D98104562J23 23D98104631K23 23D98104659L23 23D98104705J23 23D98104706J23 23D98104707J23 23D98104708J23 23D98104709J23 23D98104710J23 23D98104717J23 23D98104719J23 23D98104720J23 23D98104721J23 23D98104722J23 23D98104723J23 23D98104724J23 23D98104725J23 23D98104726J23 23D98104728J23 23D98104729J23 23D98104730J23 23D98104731J23 23D98104732J23 23D98104733J23 23D98104734J23 23D98104735J23 23D98104736J23 23D98104738J23 23D98104739J23 23D98104740J23 23D98104742J23 23D98104743J23 23D98104744J23 23D98104745J23 23D98104746J23 23D98104747J23 23D98104748J23 23D98104749J23 23D98104751J23 23D98104754J23 23D98104755J23 23D98104756J23 23D98104757J23 23D98104762J23 23D98104763J23 23D98104772J23 23D98104773J23 23D98104776J23 23D98104777J23 23D98104778J23 23D98104779J23 23D98104781J23 23D98104782J23 23D98104783J23 23D98104784J23 23D98104785J23 23D98104786J23 23D98104787J23 23D98104788J23 23D98104789J23 23D98104790J23 23D98105005K23 23D98105009K23 23D98105076J23 23D98105164J23 23D98105195J23 23D98105196J23 23D98105197J23 23D98105198J23 23D98105199J23 23D98105200J23 23D98105201J23 23D98105202J23 23D98105215J23 23D98105218J23 23D98105219J23 23D98105275J23 23D98105481L23 23D98105845J23 23D98105873J23 23D98105983J23 23D981…
UPC codes
0506016712067, 0506016712207, 0506016712804, 0506016712068, 0506016712069

Products covered by this recall

HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English with Gateway - 2 Min CPR UDI-DI code: 0506016712804 HeartSine SAM 360P 360P US Device, US English - 2 Min CPR UDI-DI code: 0506016712068 HeartSine SAM 450P SAM 450P US Device, US English (2 min CPR) UDI-DI code: 0506016712069 The HeartSine samaritan¿ PAD (Public Access Defibrillator) Models SAM 350P, SAM 360P and SAM 450P are indicated for use on victims of cardiac arrest who are exhibiting the following signs: " Unconscious " Not breathing " Without circulation (without a pulse) The devices are indicated for use on patients greater than 8 years old or over 55 lbs. (25 kg) when used with the adult Pad-Pak (Pad-Pak-01 or Pad-Pak-07). They are indicated for use on children between 1 and 8 years of age or up to 55 lbs. (25 kg) when used with the Pediatric-Pad (Pad-Pak-02).

Check your product

The notice names 10 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 0506016712067
  • 0506016712207
  • 0506016712804
  • 0506016712068
  • 0506016712069

Model or item number

On the rating label, the box or the instruction sheet.

  • SAM 350P
  • SAM 360P

Serial number

On the rating plate, often next to the date of manufacture.

  • 22D91164357L22 22D91164989L22 22D91180808

Package size

Match the net weight or the piece count on the front of the pack.

  • 55 lbs
  • 25 kg

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

HeartSine Technologies Ltd — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: HeartSine Technologies Ltd — 207 Airport Road West, Belfast

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was HeartSine Technologies Ltd medical devices recalled?

Due to a damaged (over stretched) membrane tail that causes an intermittent fault. Due to a damaged (over stretched) membrane tail that causes an intermittent fault.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 0506016712067, 0506016712207, 0506016712804; model number SAM 350P, SAM 360P. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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