Arctic Sun Temperature Management System — Class II medical device recall Z-2536-2018
Terminated recall by Bard Medical Division, reported 2018-08-01, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. An improper wiring connection on the chiller assembly may result in overheating of the connection and potentia
| Recall number | Z-2536-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Medical Division, Covington, GA, United States |
| Recall initiated | 2018-06-13 |
| Classified | 2018-07-24 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2021-02-16 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AE, AT, BE, BH, BR, CA, CH, CN, CY, CZ, DE, DK, ES, FI, FR, GB, GR, HU, IR, IT, JO, KR, MY, NL, NO, OM, PL, PT, QA, RO, RU, SA, SE, SI, TH, TR, TW, VN, ZA |
| Quantity | 5,608 units |
| Reason classes | device malfunction |
| Model numbers | 5000 |
Product
Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and controlling patient temperature within a range of 32¿C to 38.5¿C (89.6¿F to 101.3¿F) in adult and pediatric patients of all ages.
Reason for recall
An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2536-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.