CLASS II Device recall · Reported 28 Nov 2012 · FDA Enforcement Report
Modified Collagen Hemostatic Sponge Disc, 0%, Part# recalled
Superstat is recalling Superstat Modified Collagen Hemostatic Sponge Disc, 0%, Part# 9100-30, distributed nationwide in the US. The recall was initiated on 24 Oct 2012 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-0342-2013
- FDA event ID
- 63581
- Recalling firm
- Superstat, Rancho Dominguez, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Oct 2012
- FDA classified
- 16 Nov 2012
- Reported
- 28 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 24 Oct 2012 | Recall initiated by company | |
| 16 Nov 2012 | Classified by FDA | +23 days |
| 28 Nov 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
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
Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Where it was distributed
Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, Thailand, Mexico, Canada, Pakistan, Israel, Greece, Serbia, Canda, Isle of Man, Nova Scotia, and Singapore.
Questions about this recall
Is Modified Collagen Hemostatic Sponge Disc, 0%, Part# 9100-30 recalled?
Yes. Superstat recalled Modified Collagen Hemostatic Sponge Disc, 0%, Part# 9100-30 on 24 Oct 2012. The recall is Class II and its status is Terminated. Recall number Z-0342-2013.
Why was it recalled?
The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Which lots are affected?
Lot# SSN02D.
Where was it sold?
Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, Thailand, Mexico, Canada, Pakistan, Israel, Greece, Serbia, Canda, Isle of Man, Nova Scotia, and Singapore.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Superstat
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Modified Collagen Hemostatic Sponge.115mmx115mm Pledget recalled | Superstat | Sterility | Nationwide |
| Device | CLASS II | Modified Collagen Hemostatic Sponge Pledget, 0%, Part# recalled | Superstat | Sterility | Nationwide |
| Device | CLASS II | Modified Collagen Hemostatic Sponge Disc, 5%, Part# 9120 recalled | Superstat | Sterility | Nationwide |
| Device | CLASS II | Modified Collagen Hemostatic Sponge Cone, 0%, Part# 9015 recalled | Superstat | Sterility | Nationwide |
| Device | CLASS II | Modified Collagen Hemostatic Sponge Pledget, 0%, Part# recalled | Superstat | Sterility | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |