CLASS II ONGOING Device recall · Reported 25 Sep 2024 · FDA Enforcement Report
HAWK Advanced Hypothermia Management Set recalled
Safeguard US Operating is recalling HAWK Advanced Hypothermia Management Set, distributed nationwide in the US. The recall was initiated on 27 Aug 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-3182-2024
- FDA event ID
- 95183
- Recalling firm
- Safeguard US Operating, Harrisburg, NC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Aug 2024
- FDA classified
- 19 Sep 2024
- Reported
- 25 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 27 Aug 2024 | Recall initiated by company | |
| 19 Sep 2024 | Classified by FDA | +23 days |
| 25 Sep 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect expiration date.
Product as listed by the FDA
HAWK Advanced Hypothermia Management Set, Item Number: 59-320
Where it was distributed
US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, NC, NM, NY, OK, OR, RI, TX, VA, WA, WI.
Nationwide AlaskaCaliforniaColoradoDistrict of ColumbiaGeorgiaIllinoisNorth CarolinaNew MexicoNew YorkOklahomaOregonRhode IslandTexasVirginiaWashingtonWisconsin
Questions about this recall
Why was it recalled?
Incorrect expiration date.
Which lots are affected?
Item Number: 59-320; Lot Numbers: PBO0003797, PBO0003811, PBO0004032, PBO0004315, PBO0004580.
Where was it sold?
US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, NC, NM, NY, OK, OR, RI, TX, VA, WA, WI.
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.
Other products in this recall event
2 other products · FDA event 95183| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | HAWK Warming Grid recalled by Safeguard US Operating | Safeguard US Operating | Other | Nationwide | |
| CLASS II | Kits of Convenience containing 1 recalled by Safeguard US Operating | Safeguard US Operating | Other | Nationwide |
More recalls from Safeguard US Operating
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Battle Bandage recalled by Safeguard US Operating | Safeguard US Operating | Foreign Material | Nationwide |
| Device | CLASS II | Kits of Convenience containing 1 recalled by Safeguard US Operating | Safeguard US Operating | Other | Nationwide |
| Device | CLASS II | HAWK Warming Grid recalled by Safeguard US Operating | Safeguard US Operating | Other | Nationwide |
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