CLASS II ONGOING Device recall · Reported 15 Mar 2023 · FDA Enforcement Report
Heartsine Samaritan PAD: SAM 350P semi-automatic recalled
HeartSine Technologies is recalling Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic, distributed in 8 states. The recall was initiated on 1 Feb 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1217-2023
- FDA event ID
- 91659
- Recalling firm
- HeartSine Technologies, Belfast
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Feb 2023
- FDA classified
- 3 Mar 2023
- Reported
- 15 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Pacemakers & Defibrillators
Timeline
| 1 Feb 2023 | Recall initiated by company | |
| 3 Mar 2023 | Classified by FDA | +30 days |
| 15 Mar 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor
Where it was distributed
US: NJ, PA, WI, NE, TX, PA, CA, AZ, AR OUS: Australia, Czechia, Canada, New Zealand
ArkansasArizonaCaliforniaNebraskaNew JerseyPennsylvaniaTexasWisconsin
Questions about this recall
Is Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic recalled?
Yes. HeartSine Technologies recalled Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic on 1 Feb 2023. The recall is Class II and its status is Ongoing. Recall number Z-1217-2023.
Why was it recalled?
Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.
Which lots are affected?
REF/UDI-DI/Serial Numbers: SAM 350P/05060167120671/17D00006810, 19D00027547, 19D00030364, 20D00000454, 20D00000868, 20D00006232, 22D91125401, 16D01000729, 22D91145062; SAM 360P/5060167127120, 5060167128028/20E90006314, 21E91040881; SAM 500P/5060167126505, 5060167125843/17B00003113, 20B90000080
Where was it sold?
US: NJ, PA, WI, NE, TX, PA, CA, AZ, AR OUS: Australia, Czechia, Canada, New Zealand
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from HeartSine Technologies
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | HeartSine Pad-Pak recalled by HeartSine Technologies | HeartSine Technologies | Other | Nationwide |
| Device | CLASS II | HeartSine samaritan PAD (Public Access Defibrillator), Type recalled | HeartSine Technologies | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | HeartSine samaritan PAD (Public Access Defibrillator): Type recalled | HeartSine Technologies | Other | Nationwide |
| Device | CLASS II | HeartSine, REF: Pad-pak-01, Pad-pak-03 AND Pad-pak-03j, CE0123 sold recalled | HeartSine Technologies | Device Malfunction | Nationwide |
| Device | CLASS II | Pad-Pak and Pedi-Pak accessories recalled by Heartsine Technologies | Heartsine Technologies | Foreign Material | Nationwide |
Other Pacemakers & Defibrillators recalls
All 494| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DermaV Laser System recalled by Lutronic | Lutronic | Other | Nationwide |
| Device | CLASS II | Convenience kits containing select SKUs of Polycarbonate recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits: Loop Pack DYNJ61460C Open Heart recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Medline convenience kits: Acl Pack DYNJ64161C Arthroscopy recalled | Medline Industries | Foreign Material | Nationwide |
| Device | CLASS II | Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled | Medline Industries | Device Malfunction | Nationwide |