CLASS II ONGOING Device recall · Reported 28 Jul 2021 · FDA Enforcement Report
Stimulen Collagen Moisturizing Lotion, ST9555B recalled
Southwest Technologies is recalling Stimulen Collagen Moisturizing Lotion, ST9555B. The recall was initiated on 28 May 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2109-2021
- FDA event ID
- 88163
- Recalling firm
- Southwest Technologies, Kansas City, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 May 2021
- FDA classified
- 21 Jul 2021
- Reported
- 28 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 28 May 2021 | Recall initiated by company | |
| 21 Jul 2021 | Classified by FDA | +54 days |
| 28 Jul 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Dose audit failure after sterilization process
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Stimulen Collagen Moisturizing Lotion, ST9555B
Where it was distributed
Malaysia
Questions about this recall
Why was it recalled?
Dose audit failure after sterilization process
Which lots are affected?
Lot 2104007, EXP: 02/2024
Where was it sold?
Malaysia
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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