CLASS II ONGOING Device recall · Reported 15 Jul 2026 · FDA Enforcement Report

Aquacel Ag Surgical SP recalled by ConvaTec

ConvaTec is recalling Aquacel Ag Surgical SP, distributed nationwide in the US. The recall was initiated on 8 Jun 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot/Batch: 5G00809; Primary Pack UDI: (01) 00768455130764/ Secondary Pack UDI: (01) 00768455130634/ Tertiary Pack UDI: (01) 10768455130631

Quantity recalled4230 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2677-2026
FDA event ID: 99151
Recalling firm: ConvaTec, Greensboro, NC
Classification: Class II
Status: Ongoing
Recall initiated: 8 Jun 2026
FDA classified: 7 Jul 2026
Reported: 15 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Surgical Instruments

Timeline

8 Jun 2026	Recall initiated by company
7 Jul 2026	Classified by FDA	+29 days
15 Jul 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Surgical dressing manufactured out of specification (greater thickness).

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Arizona California Colorado Delaware Florida Georgia Illinois Indiana Kansas Maryland Michigan Minnesota Mississippi North Carolina New Mexico New York Ohio Pennsylvania Tennessee Texas

Questions about this recall

Is Aquacel Ag Surgical SP recalled?

Yes. ConvaTec recalled Aquacel Ag Surgical SP on 8 Jun 2026. The recall is Class II and its status is Ongoing. Recall number Z-2677-2026.

Why was it recalled?

Surgical dressing manufactured out of specification (greater thickness).

Which lots are affected?

Lot/Batch: 5G00809; Primary Pack UDI: (01) 00768455130764/ Secondary Pack UDI: (01) 00768455130634/ Tertiary Pack UDI: (01) 10768455130631

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from ConvaTec

All 54

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	Esteem Body Soft Convex Urostomy recalled by ConvaTec	ConvaTec	Packaging Defects	Nationwide
25 Mar 2026Device	CLASS II	EsteemBody Drainable recalled by ConvaTec	ConvaTec	Packaging Defects	Nationwide
25 Mar 2026Device	CLASS II	EsteemBody Drainable recalled by ConvaTec	ConvaTec	Packaging Defects	Nationwide
25 Mar 2026Device	CLASS II	EsteemBody Drainable recalled by ConvaTec	ConvaTec	Packaging Defects	Nationwide
22 Oct 2025Device	CLASS II	DuoDERM" Extra Thin dressings are highly flexible recalled by ConvaTec	ConvaTec	Foreign Material	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide