ConvaTec Aquacel Ag Surgical SP Dressing Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
ConvaTec, Inc. is recalling 4,230 units of Aquacel Ag Surgical SP surgical dressings due to manufacturing out of specification.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 9, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
What Happened
ConvaTec, Inc. initiated a voluntary recall of Aquacel Ag Surgical SP surgical dressings because the product was manufactured out of specification with greater thickness.
Which Products Are Affected
The recall affects Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R. A total of 4,230 units are involved, distributed nationwide 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. The affected lot/batch is 5G00809. Primary Pack UDI: (01) 00768455130764; Secondary Pack UDI: (01) 00768455130634; Tertiary Pack UDI: (01) 10768455130631. Recall number Z-2677-2026. Classification: Class II.
What You Should Do
Consumers should contact ConvaTec, Inc. for return or refund instructions regarding the affected products.
Why This Matters
The recall involves 4,230 units of surgical dressings distributed across 21 states due to a manufacturing defect.
Source
FDA recall Z-2677-2026, report date 20260715.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,003 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.