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FDA Medical Device Recalls (openFDA)

JK Products & Services, Inc: BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.

Recall number
Z-2183-2012
Recalling firm
JK Products & Services, Inc
Product
BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.
Status
Terminated
Initiated
2012-05-07
Posted
2012-08-10
Terminated
2015-01-07
Reason
The Beauty Angel was marketed without a 510k.
Root cause
No Marketing Application
Action
JK Products sent a Mandatory Field Correction Notice - Immediate Action Required letter dated February 10, 2012, to all affected customers. The letter identified the product the problem, and the action to be taken by the customer. The firm instructed customers that they would be replacing the operating instructions for the affected product with new ones that meet the requirements defined by the regulatory authorities. Customers were instructed not to make claims that indicate that using the affected product will result in medical or health benefits, or that directly or indirectly imply that the affected product is intended to cure, treat, diagnose or pevent an illness, or disease. Customers were asked to complete the new owner information request on the return post care enclosed and return to the firm. If product was further distributed those accounts should be contacted immediately and should be advised of this Mandatory Field Correction Notice. For questions customers should call 870-935-1130. For questions regarding this recall call 870-268-2702.
Quantity
598 units
Distribution
Worldwide Distribution - USA (nationwide) and Canada
Lot, serial or model codes
All Beauty Angel Models and Serial Numbers Part Numbers 80000904301 and 8001110201.
510(k) numbers
not on file
PMA numbers
not on file
Product code
000
Firm FEI
2311923
Firm city
Jonesboro
Firm state
AR
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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