AQUACEL AG SURGICAL 413556Recalls & reported problems

Convatec, Purchasing Department · AQUACEL AG SURGICAL SP 9X15CM (1X10)NAI · Class U

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Jun 8, 2026Class IIOpen, Classified
Surgical dressing manufactured out of specification (greater thickness).
Z-2677-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Device details

UDI-DI	`00768455130764`
Brand	AQUACEL AG SURGICAL
Model	413556
Company	Convatec, Purchasing Department
Product code	FRO · Dressing, Wound, Drug
Class	Class U
FDA submission	K152926
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Dec 4, 2023

Device type (GMDN): Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.

Other Dressing, Wound, Drug devices

MediHoney® 31815
Acell, Inc. · Dressing, wound, drug
2 recalls7 reports
MediHoney® 31515
Acell, Inc. · Dressing, wound, drug
2 recalls6 reports
MediHoney® 31805
Acell, Inc. · Dressing, wound, drug
2 recalls1 death5 reports
MediHoney® 31535
Acell, Inc. · Dressing, wound, drug
2 recalls0 reports
AQUACEL AG FOAM 420681
Convatec, Purchasing Department · Dressing, Wound, Drug
99 reports
SteriCare Solutions 6240
Nurse Assist, Inc. · Dressing, Wound, Drug
1 recall14 reports
MEDLINE MNK0005
Medline Industries, Inc. · Dressing, wound, drug
1 recall5 reports
Medline DYND500MLS
Medline Industries, Inc. · Dressing, wound, drug
1 recall5 reports

All Dressing, Wound, Drug devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page