Z-0204-2018Class II

Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336

Name: Z-0204-2018 Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336
Creator: Won Industry Co.
Published: 2017-01-13
License: https://open.fda.gov/license/

Won Industry Co. / initiated 2017-01-13 / Terminated / root cause: manufacturing process

FDA source

Won Industry Co. began a recall of Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 Product Usage: Intended for limb massage utilizing air compression. It is specially designed to... on 2017-01-13. FDA classified it as Class II and gives the reason as "Distribution of unapproved devices with incorrect air compression level setup". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0204-2018
Classification: Class II
Status: Terminated
Initiated: 2017-01-13
Posted: 2017-12-06
Terminated: 2023-05-24
Recalling firm: Won Industry Co.
Product: Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device. It helps to prevent the blood blockage in cardiovascular and to relax stressed muscle by increasing the temperature of hypodermic tissue and expanding the blood vessels. It vitalizes the circulation of blood and lymph in arms, legs and waist and enhances the pressure of muscular issues to remove swelling or pain.
Product code: IRP Massager, Powered Inflatable Tube
Reason for recall: Distribution of unapproved devices with incorrect air compression level setup
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Beginning on January 13, 2017, Won Industry Co., Ltd. distributed a Recall Request notices to their customers via email advising customers to retrieve the devices subject to recall.
Quantity in commerce: 2
Distribution: Worldwide distribution - US Nationwide - Domestic: MD & TX; Internationally: Mexico
Product codes and lots: Serial numbers: EMM16100968 and EMM16100967 MFG DATE: 2016.10.10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0204-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0204-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-13	2017-12-06
Z-0205-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-13	2017-12-06

Product code IRP

K120166Class IICompressible Limb and Circulation Therapy SystemWon Industrial Co. / cleared 2012-05-14

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)