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
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
- Reason category
- Potency & Assay
- 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).
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
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 ArizonaCaliforniaColoradoDelawareFloridaGeorgiaIllinoisIndianaKansasMarylandMichiganMinnesotaMississippiNorth CarolinaNew MexicoNew YorkOhioPennsylvaniaTennesseeTexas
Questions about this recall
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 26 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 |
|---|---|---|---|---|---|
| Device | CLASS II | Esteem Body Soft Convex Urostomy recalled by ConvaTec | ConvaTec | Packaging Defects | Nationwide |
| Device | CLASS II | EsteemBody Drainable recalled by ConvaTec | ConvaTec | Packaging Defects | Nationwide |
| Device | CLASS II | EsteemBody Drainable recalled by ConvaTec | ConvaTec | Packaging Defects | Nationwide |
| Device | CLASS II | EsteemBody Drainable recalled by ConvaTec | ConvaTec | Packaging Defects | Nationwide |
| Device | CLASS II | DuoDERM" Extra Thin dressings are highly flexible recalled by ConvaTec | ConvaTec | Foreign Material | Nationwide |
Other Surgical Instruments recalls
All 3,883| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hopkins Telescope 30¿ recalled by Karl Storz Endoscopy | Karl Storz Endoscopy | Packaging Defects | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 24" X 4" 1-Line, Yellow recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Mpr Single Use Tourniquet Cuff 15" 1 Line recalled by ASP Global | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Expressaire Disposable Tourniquet Cuff, 12" X 3.5" 1-Line (CS Plum recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 44" X 4" 2-Line, Green recalled | ASP Global | Device Malfunction | Nationwide |