Z-0160-2026Class II

DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to...

Name: Z-0160-2026 DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to...
Creator: ConvaTec, Inc
Published: 2025-08-29
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2025-08-29 / Open, Classified / root cause: manufacturing process

FDA source

ConvaTec, Inc began a recall of DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin... on 2025-08-29. FDA classified it as Class II and gives the reason as "Wound dressing may have foreign matter on the product". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0160-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-29
Posted: 2025-10-16
Recalling firm: ConvaTec Limited
Product: DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas subject to friction and those requiring contouring, e.g., elbows, heels. DuoDERM" Extra Thin dressings interact with wound moisture producing a soft mass that enables removal of the dressing with little or no damage to newly formed tissues. They help isolate the wound against bacterial and other external contamination. INDICATIONS " Management of superficial, dry to lightly exudating dermal ulcers. " Post-operative wounds. " Protective dressings.
Product code: NAD Dressing, Wound, Occlusive
Reason for recall: Wound dressing may have foreign matter on the product.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 8/29/2025, Recall Notices were emailed to customers who were asked to do the following: 1) Quarantine and stop distribution of affected stock. 2) Notify downstream recipients of this product. 3) Confirm receipt of this notice via survey link and ensure all affected inventory is identified, managed, and where applicable destroyed. Questions can be directed to the firm at: [email protected]
Quantity in commerce: 80,980
Distribution: US Nationwide distribution including in the states of OH, AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV.
Product codes and lots: UDI-DI: 768455150922, Lot: 3L04808

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0160-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0160-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16

Product code NAD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)