CLASS II Device recall · Reported 13 Feb 2013 · FDA Enforcement Report
SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN recalled
Allergen Medical is recalling SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN, distributed in 13 states. The recall was initiated on 8 Jan 2013 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-0794-2013
- FDA event ID
- 64069
- Recalling firm
- Allergen Medical, Medford, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Jan 2013
- FDA classified
- 7 Feb 2013
- Reported
- 13 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 8 Jan 2013 | Recall initiated by company | |
| 7 Feb 2013 | Classified by FDA | +30 days |
| 13 Feb 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured
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
SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
Where it was distributed
Worldwide Distribution-USA including the states of CA, FL, GA, MI, MN, NJ, NY, OH, OR, RI, TX, VA, and WA, and the countries of Germany, Spain, and UK.
CaliforniaFloridaGeorgiaMichiganMinnesotaNew JerseyNew YorkOhioOregonRhode IslandTexasVirginiaWashington
Questions about this recall
Why was it recalled?
Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured
Which lots are affected?
Lot Numbers: P2012040901 (US) P2011080101B and P2011090901A (Outside the US)
Where was it sold?
Worldwide Distribution-USA including the states of CA, FL, GA, MI, MN, NJ, NY, OH, OR, RI, TX, VA, and WA, and the countries of Germany, Spain, and UK.
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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