FDA recall Z-2677-2026

ConvaTec, Inc · Class II · device

Product

Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R

Reason for recall

Surgical dressing manufactured out of specification (greater thickness).

Distribution

US Nationwide distribution in the states of MD, OH, IL, NC, AZ, NY, MN, TX, KS, TN, IN, DE, MI, FL, PA, CA, VA, MS, NM, GA, CO.

Key facts

Status
Ongoing
Initiation date
2026-06-08
Report date
2026-07-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Greensboro, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2677-2026