CLASS II ONGOING Device recall · Reported 22 May 2024 · FDA Enforcement Report
HeartSine samaritan PAD (Public Access Defibrillator), Type recalled
HeartSine Technologies is recalling HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P, distributed nationwide in the US. The recall was initiated on 8 Apr 2024 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-1820-2024
- FDA event ID
- 94076
- Recalling firm
- HeartSine Technologies, Belfast, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Apr 2024
- FDA classified
- 14 May 2024
- Reported
- 22 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Pacemakers & Defibrillators
Timeline
| 8 Apr 2024 | Recall initiated by company | |
| 14 May 2024 | Classified by FDA | +36 days |
| 22 May 2024 | Published in enforcement report | +8 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 have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be present, but this issue could potentially lead to no therapy or a delay in therapy.
Product as listed by the FDA
HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
Where it was distributed
US Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, GC, HI, IA, ID, IL, IN, KS, KY, LA, MA, MB, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be present, but this issue could potentially lead to no therapy or a delay in therapy.
Which lots are affected?
UDI-DI: 5060167125379, 5060167120688, 5060167125720, 5060167128066, 5060167122330, 5060167122491, M727SAM450P, 5060167122514, 5060167121371, 5060167120671, 5060167121630, 5060167128042, 5060167120701, 5060167128080, 5060167120695, 5060167120725, 5060167120718, 5060167120909, 5060167120916, 5060167122071, 5060167120893. Devices affected by this notification begin with the following prefixes and device codes: 16D, 16E, 16G, 17D, 17E, 17G, 18D, 18E, 18G, 19D, 19E, 19G, 20D, 20E, 20G, 21D, 21E, 21G, 22D, 22E, 22G, 23D, 23E, 23G, 24D, 24E, 24G Serial Numbers: The prefix (device identifier) consists of the manufacturing date (YY) and the device model (B, D, E, G, or H) and an 8-digit serial number string. Example: 16D00001234
Where was it sold?
US Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, GC, HI, IA, ID, IL, IN, KS, KY, LA, MA, MB, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY.
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 26 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 | 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 | Heartsine Samaritan PAD: SAM 350P semi-automatic recalled | HeartSine Technologies | Other | 8 states |
| Device | CLASS II | Pad-Pak and Pedi-Pak accessories recalled by Heartsine Technologies | Heartsine Technologies | Packaging Defects | Nationwide |
Other Pacemakers & Defibrillators recalls
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|---|---|---|---|---|---|
| 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 | Device Malfunction | Nationwide |
| Device | CLASS II | Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled | Medline Industries | Device Malfunction | Nationwide |