Z-2109-2021Class II

Stimulen Collagen Moisturizing Lotion, ST9555B

Name: Z-2109-2021 Stimulen Collagen Moisturizing Lotion, ST9555B
Creator: Southwest Technologies Inc
Published: 2021-05-28
License: https://open.fda.gov/license/

Southwest Technologies Inc / initiated 2021-05-28 / Open, Classified / root cause: sterility

FDA source

Southwest Technologies Inc began a recall of Stimulen Collagen Moisturizing Lotion, ST9555B on 2021-05-28. FDA classified it as Class II and gives the reason as "Dose audit failure after sterilization process". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2109-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-05-28
Posted: 2021-07-21
Recalling firm: Southwest Technologies Inc
Product: Stimulen Collagen Moisturizing Lotion, ST9555B
Product code: KGN Wound Dressing With Animal-Derived Material(S)
Reason for recall: Dose audit failure after sterilization process
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: The firm notified its sold consignee of the issue by telephone on 05/28/2021 of the issue. The firm followed with a letter disseminated by letter on 06/18/2021 requesting that the distributor destroy any product on hand and notify their customers.
Quantity in commerce: 2016 units
Distribution: Malaysia
Product codes and lots: Lot 2104007, EXP: 02/2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2109-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2109-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-21

Product code KGN

K030774UnclassifiedStimulen CollagenSouthwest Technologies, Inc. / cleared 2004-08-09

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)