FDA-Drug2026-10-27Class IIPROCESSING DEFECT

Certus Medical Satin Foam recalled over manufacturing quality issues

OTHERNationwide distributionDrugs

What this means

The FDA has announced a recall of about 28,152 bottles of Certus Medical Satin Foam, 750 mL (25.4 fl. oz.), sold nationwide. The recall is due to violations of current good manufacturing practices (CGMP), which are quality standards for how medical products are made. No injuries have been reported.

  • Check whether you have a 750 mL bottle of Certus Medical Satin Foam with UPC 711808250930.
  • Contact the pharmacy, store, or supplier where you bought it for next steps, since no remedy has been specified.
  • If you rely on this product and have concerns, ask your healthcare provider about alternatives.
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The agency's original wording
Hazard

CGMP Deviations

Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide
Affected count
28152 bottles
Manufactured in
2600 Dogwood Dr Se, Conyers, Georgia, United States
Products
Certus Medical Satin Foam, 750 ml (25.4 fl. oz.), Manufactured for: Cartus Medical, 2600 Dogwood Dr., Conyers, GA 30013, UPC 711808250930

UPC codes

  • 711808250930

Products in this recall · 19

The agency lists each product in this recall separately. Check every one you might have.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0088-2027

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