Recall Z-2677-2026— ConvaTec, Inc

Name: FDA recall Z-2677-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-08

Class II · Ongoing

Class II FDA medical device recall by ConvaTec, Inc, initiated 2026-06-08. It names one FDA 510(k) clearance: K152926. Product: Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R. Reason: Surgical dressing manufactured out of specification (greater thickness)..

Recalling firm: ConvaTec, Inc
Classification: Class II
Status: Ongoing
Initiated: 2026-06-08
Firm location: Greensboro, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K152926 — AQUACEL Ag Surgical SP DressingConvatec Limited·cleared 2016-01-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.