Model 055: Thermophore Classic — Class II medical device recall Z-0349-2017
Terminated recall by Battle Creek Equipment Co., reported 2016-11-09, distributed in PR. Products manufactured with the SPT cord have a known failure mode of sparking,causing smoke, fire and burns.
| Recall number | Z-0349-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Battle Creek Equipment Co., Fremont, IN, United States |
| Recall initiated | 2016-09-15 |
| Classified | 2016-11-03 |
| Reported by FDA | 2016-11-09 |
| Terminated | 2018-01-11 |
| Distributed | PR |
| Countries outside the US | CA, MX |
| Quantity | 99,060 |
| Lot numbers | 0550112, 0550113, 055013, 0550213, 0550214, 0550313, 0550314, 0550413, 0550414, 0550513, 0550514, 0550613, 0550614, 0550713, 0550714, 0550813, 0550814, 0550913, 0550914, 0551013, 0551014, 0551113, 0551114, 0551213, 0551313, 0551413, 0551513, 0551613, 0551713, 0551813, 0551913, 0552013, 0552113, 0552213, 0552313, 0552413, 0552513, 0552613, 0552712, 0552713 and 460 more |
| Model numbers | 055, 056, 077, 095, 096, 097, 255, 256, 277, F00055-055, F00056-056, F00077-077, F00255-255, F00256-256, F00277-277, F80095-095, F80096-096, F80097-097 |
Product
Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Model 077 Petite 4"x 17",Model 095: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 095 Large 14" x 27 Model 096: Thermophore Classic, Professional Quality Deep-Heat therapy Model 096, Medium, 14" x 14" Model 097: Thermophore Classic, Professional quality Deep-Heat Therapy, Model 097 , Petite, 4" x 17", Model 255: Thermophore Classic Plus, Professional Quality Deep-Heat Therapy, Model 255 Large,14" x 27", Model 256: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 256, Medium, 14" X 14 Model 277: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 277, Petite , 4" x 17" Used for the temporary relief of joint and muscle pain.
Reason for recall
Products manufactured with the SPT cord have a known failure mode of sparking,causing smoke, fire and burns.
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-0349-2017. 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.