Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1084-2021Class II

Wahl 4212 Heated Massager, Sku F800000004212 -

Wahl Clipper Corp / initiated 2020-12-15 / Terminated / root cause: design

Wahl Clipper Corp began a recall of WAHL 4212 HEATED MASSAGER, SKU F800000004212 - Product Usage: intended to relieve minor muscle aches and pains on . FDA classified it as Class II and gives the reason as "The connection between the massager and heat element can overheat causing smoke or spark, which may pose a fire hazard". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1084-2021
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Wahl Clipper Corp
Product
WAHL 4212 HEATED MASSAGER, SKU F800000004212 - Product Usage: intended to relieve minor muscle aches and pains.
Product code
ISA Massager, Therapeutic, Electric
Reason for recall
The connection between the massager and heat element can overheat causing smoke or spark, which may pose a fire hazard
Root cause tag
design
FDA root cause
Device Design
Action
Wahl initiated the recall on 12/15/2020 to its direct consignee by email and posted a notice on its website www.fda.gov on 12/23/2020. The firm is requesting the return of the units.
Quantity in commerce
161 units
Distribution
US Nationwide distribution including in the states of CT, FL, UT, MO, WI, FL, CA, IL, PA.
Product codes and lots
all lots

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1084-2021
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1084-2021Class IITerminatedVoluntary: Firm initiated