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FDA Medical Device Recalls (openFDA)

Avazzia, Inc: Avazzia Med-Best Therapeutic Massager; Model: BEST AV-1; P/N #MB04182-103; manufactured by Avazzia, Inc., Dallas, TX 75240.

Recall number
Z-1209-2007
Recalling firm
Avazzia, Inc
Product
Avazzia Med-Best Therapeutic Massager; Model: BEST AV-1; P/N #MB04182-103; manufactured by Avazzia, Inc., Dallas, TX 75240.
Status
Terminated
Initiated
2007-06-29
Posted
2007-09-01
Terminated
2008-04-04
Reason
Plastic Cases may crack due to manufacturing by the supplier not meeting specifications
Root cause
Other
Action
Firm notified consignees by letter on June 29, 2007 requesting that all affected product be returned to the firm for repair or replacement. The firm further asked for distributors who had shipped affected product to notify receiving patients so they could arrange for repair or replacement.
Quantity
61 units
Distribution
Nationwide including states of Texas, Pennsylvania, Louisiana, Wyoming, and California
Lot, serial or model codes
Lot Number AC024; The lot number can be found on the serial number label located in the recess of the case where the batteries are installed. If the serial number has "AC024" in the middle, then that device is being recalled.
510(k) numbers
not on file
PMA numbers
not on file
Product code
GZJ
Firm FEI
3004839404
Firm city
Dallas
Firm state
TX
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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