Z-0349-2017Class II

Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model...

Name: Z-0349-2017 Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model...
Creator: Battle Creek Equipment Co.
Published: 2016-09-15
License: https://open.fda.gov/license/

Battle Creek Equipment / initiated 2016-09-15 / Terminated / root cause: design

FDA source

Battle Creek Equipment Co. began a recall of Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality... on 2016-09-15. FDA classified it as Class II and gives the reason as "Products manufactured with the SPT cord have a known failure mode of sparking,causing smoke, fire and burns". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0349-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-15
Posted: 2016-11-03
Terminated: 2018-01-11
Recalling firm: Battle Creek Equipment
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.
Product code: IRT Pad, Heating, Powered
Reason for recall: Products manufactured with the SPT cord have a known failure mode of sparking,causing smoke, fire and burns.
Root cause tag: design
FDA root cause: Device Design
Action: All consumers for which Battle Creek has contact information and that purchased a recalled pad will be contacted via first class mail. Consumers will be asked to contact us by phone after verifying that the model number and lot code is part of the recall. Battle Creek plans to add information about the recall on its web site including a pdf of the consumer letter. All customer consignees (non-consumer) will be informed of the recall. Email will be the most effective method , and mail and telephone calls will be used as needed.
Quantity in commerce: 99,060
Distribution: Distributed within the United States, Canada, Mexico, Puerto Rico and Columbia
Product codes and lots: Model F00055-055 Standard Thermophore Lot codes: 0552712, 0552812, 0552912, 0553012, 0553112, 0553212, 0553312, 0553412, 0553512 , 0553612, 0553712, 0553812, 0553912, 0554012, 0554112, 0554212, 0554312, 0554412, 0554512, 0554612, 0554712, 0554812, 0554912, 0555012, 0555112, 0555212, 0550112, 0550213, 0550313, 0550413, 0550513, 0550613, 0550713, 0550813, 0550913, 0551013, 0551113, 0551213, 0551313, 0551413, 0551513, 0551613, 0551713, 0551813, 0551913, 0552013, 0552113, 0552213, 0552313, 0552413, 0552513, 0552613, 0552713, 0552813, 0552913, 0553013, 0553113, 0553213, 0553313, 0553413, 0553513, 0553613, 0553713, 0553813, 0553913, 0554013, 0554113, 0554213, 0554313, 0554413, 0554513, 0554613, 0554713, 0554813, 0554913, 055013, 0555113, 0555213, 0550113, 0550214, 0550314, 0550414, 0550514, 0550614, 0550714, 0550814, 0550914, 0551014, 0551114 Model F00255-255 Standard Thermophore Plus Lot codes: 2552712, 2552812, 2552912, 2553012, 2553112, 2553212, 2553312, 2553412, 2553512, 2553612, 2553712, 2553812, 2553912, 2554012, 2554112, 2554212, 2554312, 2554412, 2554512, 2554612, 2554712, 2554812, 2554912, 2555012, 2555112, 2555212, 2550112, 2550213, 2550313, 2550413, 2550513, 2550613, 2550713, 2550813, 2550913, 2551013, 2551113, 2551213, 2551313, 2551413, 2551513, 2551613, 2551713, 2551813, 2551913, 2552013, 2552113, 2552213, 2552313, 2552413, 2552513, 2552613, 2552713, 2552813, 2552913, 2553013, 2553113, 2553213, 2553313, 2553413, 2553513, 2553613, 2553713, 2553813, 2553913, 2554013, 2554113, 2554213, 2554313, 2554413, 2554513, 2554613, 2554713, 2554813, 2554913, 2555013, 2555113, 2555213, 2550113, 2550214, 2550314, 2550414, 2550514, 2550614, 2550714, 2550814, 2550914, 2551014, 2551114 Model F80095-095 Standard CSA Thermophore Lot code: 0952712, 0952812, 0952912, 0953012, 0953112, 0953212, 0953312, 0953412, 0953512, 0953612, 0953712, 0953812, 0953912, 0954012, 0954112, 0954212, 0954312, 0954412, 0954512, 0954612, 0954712, 0954812, 0954912, 0955012, 0955112, 0955212, 0950112, 0950213, 0950313, 0950413, 0950513, 0950613, 0950713, 0950813, 0950913, 0951013, 0951113, 0951213, 0951313, 0951413, 0951513, 0951613, 0951713, 0951813, 0951913, 0952013, 0952113, 0952213, 0952313, 0952413, 0952513, 0952613, 0952713, 0952813, 0952913, 0953013, 0953113, 0953213, 0953313, 0953413, 0953513, 0953613, 0953713, 0953813, 0953913, 0954013, 0954113, 0954213, 0954313, 0954413, 0954513, 0954613, 0954713, 0954813, 0954913, 0955013, 0955113, 0955213, 0950113, 0950214, 0950314, 0950414, 0950514, 0950614, 0950714, 0950814, 0950914, 0951014, 0951114 Model F00077-077 Petite Thermophore Lot codes: 0772712, 0772812, 0772912, 0773012, 0773112, 0773212, 0773312, 0773412, 0773512, 0773612, 0773712, 0773812, 0773912, 0774012, 0774112, 0774212, 0774312, 0774412, 0774512, 0774612, 0774712, 0774812, 0774912, 0775012, 0775112, 0775212, 0770112, 0770213, 0770313, 0770413, 0770513, 0770613, 0770713, 0770813, 0770913, 0771013, 0771113, 0771213, 0771313, 0771413, 0771513, 0771613, 0771713, 0771813, 0771913, 0772013, 0772113, 0772213, 0772313, 0772413, 0772513, 0772613, 0772713, 0772813, 0772913, 0773013, 0773113, 0773213, 0773313, 0773413, 0773513, 0773613, 0773713, 0773813, 0773913, 0774013, 0774113, 0774213, 0774313, 0774413, 0774513, 0774613, 0774713, 0774813, 0774913, 0775013, 0775113, 0775213, 0770113, 0770214, 0770314, 0770414, 0770514, 0770614, 0770714, 0770814, 0770914, 0771014, 0771114, 0771214, 0771314, 0771414, 0771514, 0771614, 0771714, 0771814, 0771914, 0772014, 0772114, 0772214, 0772314, 0772414, 0772514, 0772614, 0772714 Model F00277-277 Petite Thermophore Plus lot codes: 2772712, 2772812, 2772912, 2773012, 2773112, 2773212, 2773312, 2773412, 2773512, 2773612, 2773712, 2773812, 2773912, 2774012, 2774112, 2774212, 2774312, 2774412, 2774512, 2774612, 2774712, 2774812, 2774912, 2775012, 2775112, 2775212, 2770112, 2770213, 2770313, 2770413, 2770513, 2770613, 2770713, 2770813, 2770913, 2771013, 2771113, 2771213, 2771313, 2771413, 2771513, 2771613, 2771713, 2771813, 2771913, 2772013, 2772113, 2772213, 2772313, 2772413, 2772513, 2772613, 2772713, 2772813, 2772913, 2773013, 2773113, 2773213, 2773313, 2773413, 2773513, 2773613, 2773713, 2773813, 2773913, 2774013, 2774113, 2774213, 2774313, 2774413, 2774513, 2774613, 2774713, 2774813, 2774913, 2775013, 2775113, 2775213, 2770113, 2770214, 2770314, 2770414, 2770514, 2770614, 2770714, 2770814, 2770914, 2771014, 2771114, 2771214, 2771314, 2771414, 2771514, 2771614, 2771714, 2771814, 2771914, 2772014, 2772114, 2772214, 2772314, 2772414, 2772514, 2772614, 2772714 Model F80097-097 Petite CSA Thermophore Lot codes: 0972712, 0972812, 0972912, 0973012, 0973112, 0973212, 0973312, 0973412, 0973512, 0973612, 0973712, 0973812, 0973912, 0974012, 0974112, 0974212, 0974312, 0974412, 0974512, 0974612, 0974712, 0974812, 0974912, 0975012, 0975112, 0975212, 0970112, 0970213, 0970313, 0970413, 0970513, 0970613, 0970713, 0970813, 0970913, 0971013, 0971113, 0971213, 0971313, 0971413, 0971513, 0971613, 0971713, 0971813, 0971913, 0972013, 0972113, 0972213, 0972313, 0972413, 0972513, 0972613, 0972713, 0972813, 0972913, 0973013, 0973113, 0973213, 0973313, 0973413, 0973513, 0973613, 0973713, 0973813, 0973913, 0974013, 0974113, 0974213, 0974313, 0974413, 0974513, 0974613, 0974713, 0974813, 0974913, 0975013, 0975113, 0975213, 0970113, 0970214, 0970314, 0970414, 0970514, 0970614, 0970714, 0970814, 0970914, 0971014, 0971114, 0971214, 0971314, 0971414, 0971514, 0971614, 0971714, 0971814, 0971914, 0972014, 0972114, 0972214, 0972314, 0972414, 0972514, 0972614, 0972714 Model F00056-056 Medium Thermophore Lot codes: 0562712, 0562812, 0562912, 0563012, 0563112, 0563212, 0563312, 0563412, 0563512, 0563612, 0563712, 0563812, 0563912, 0564012, 0564112, 0564212, 0564312, 0564412, 0564512, 0564612, 0564712, 0564812, 0564912, 0565012, 0565112, 0565212, 0560112, 0560213, 0560313, 0560413, 0560513, 0560613, 0560713, 0560813, 0560913, 0561013, 0561113, 0561213, 0561313, 0561413, 0561513, 0561613, 0561713, 0561813, 0561913, 0562013, 0562113, 0562213, 0562313, 0562413, 0562513, 0562613, 0562713, 0562813, 0562913, 0563013, 0563113, 0563213, 0563313, 0563413, 0563513, 0563613, 0563713, 0563813, 0563913, 0564013, 0564113, 0564213, 0564313, 0564413, 0564513, 0564613, 0564713, 0564813, 0564913, 0565013, 0565113, 0565213, 0560113, 0560214, 0560314, 0560414, 0560514, 0560614, 0560714, 0560814, 0560914, 0561014, 0561114, 0561214, 0561314, 0561414, 0561514, 0561614, 0561714, 0561814, 0561914,0562014, 0562114, 0562214, 0562314, 0562414, 0562514, 0562614, 0562714, 0562814, 0562914 Model-F00256-256 Medium thermophore Plus lot codes: 2562712, 2562812, 2562912, 2563012, 2563112, 2563212, 2563312, 2563412, 2563512, 2563612, 2563712, 2563812, 2563912, 2564012, 2564112, 2564212, 2564312, 2564412, 2564512, 2564612, 2564712, 2564812, 2564912, 2565012, 2565112, 2565212, 2560112, 2560213, 2560313, 2560413, 2560513, 2560613, 2560713, 2560813, 2560913, 2561013, 2561113, 2561213, 2561313, 2561413, 2561513, 2561613, 2561713, 2561813, 2561913, 2562013, 2562113, 2562213, 2562313, 2562413, 2562513, 2562613, 2562713, 2562813, 2562913, 2563013, 2563113, 2563213, 2563313, 2563413, 2563513, 2563613, 2563713, 2563813, 2563913, 2564013, 2564113, 2564213, 2564313, 2564413, 2564513, 2564613, 2564713, 2564813, 2564913, 2565013, 2565113, 2565213, 2560113, 2560214, 2560314, 2560414, 2560514, 2560614, 2560714, 2560814, 2560914, 2561014, 2561114, 2561214, 2561314, 2561414, 2561514, 2561614, 2561714, 2561814, 2561914, 2562014, 2562114, 2562214, 2562314, 2562414, 2562514, 2562614, 2562714, 2562814, 2562914 Model F80096-096 Medium CSA Thermophore Lot codes: 0962712, 0962812, 0962912, 0963012, 0963112, 0963212, 0963312, 0963412, 0963512, 0963612, 0963712, 0963812, 0963912, 0964012, 0964112, 0964212, 0964312, 0964412, 0964512, 0964612, 0964712, 0964812, 0964912, 0965012, 0965112, 0965212, 0960112, 0960213, 0960313, 0960413, 0960513, 0960613, 0960713, 0960813, 0960913, 0961013, 0961113, 0961213, 0961313, 0961413, 0961513, 0961613, 0961713, 0961813, 0961913, 0962013, 0962113, 0962213, 0962313, 0962413, 0962513, 0962613, 0962713, 0962813, 0962913, 0963013, 0963113, 0963213, 0963313, 0963413, 0963513, 0963613, 0963713, 0963813, 0963913, 0964013, 0964113, 0964213, 0964313, 0964413, 0964513, 0964613, 0964713, 0964813, 0964913, 0965013, 0965113, 0965213, 0960113, 0960214, 0960314, 0960414, 0960514, 0960614, 0960714, 0960814, 0960914, 0961014, 096111, 40961214, 0961314, 0961414, 0961514, 0961614, 0961714, 0961814, 0961914, 0962014, 0962114, 0962214, 0962314, 0962414, 0962514, 0962614, 0962714, 0962814, 0962914

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0349-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0349-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-03

Product code IRT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)