Z-2677-2026 Class II Ongoing
FDA device recall Z-2677-2026 was initiated by ConvaTec, Inc on June 8, 2026 and is designated Class II. Reason for recall: Surgical dressing manufactured out of specification (greater thickness). The recall status is ongoing. Affected quantity: 4230 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2026
- Initiation Date
- June 8, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4230 units
Product Description
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 Pattern
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.
Code Information
Lot/Batch: 5G00809; Primary Pack UDI: (01) 00768455130764/ Secondary Pack UDI: (01) 00768455130634/ Tertiary Pack UDI: (01) 10768455130631