Dressing, Wound, Occlusive
FDA adverse event reports and recall history for dressing, wound, occlusive (product code NAD), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 14,970
- Deaths
- 7
- Injuries
- 894
- Malfunctions
- 14,047
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-10-16Open, ClassifiedProcess control
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.
Wound dressing may have foreign matter on the product.
- 2025-04-04Open, ClassifiedUnder Investigation by firm
Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2; 2) MJ BANDAGE HYDROCOLLOID ALL PURP 10CT, Model Number: MJ18005V2; 3) MJ BNDG HYDROCOLLOID FINGER TOE 8CT, Model Number: MJ76126V2; 4) WALMART,BANDAGE,HYDROCOLLOID,HEEL,6CT, Model Number: WAL1901; 5) WALMART,HYDROCOLLOID,TOE,8CT, Model Number: WAL1902;
There is a potential for the sterility of the device to be compromised.
- 2017-03-27TerminatedPackaging process control
Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.
Product sterility is compromised due to breach of sterile barrier
- 2017-03-27TerminatedPackaging process control
Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile Item Code: 3339 Curity Sodium Chloride Dressing is indicated for use on exudating and/or infected wounds
Product sterility is compromised due to breach of sterile barrier
- 2017-03-27TerminatedPackaging process control
Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code: 3606 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.
Product sterility is compromised due to breach of sterile barrier
- 2014-10-24TerminatedLabeling mix-ups
Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used throughout the healing process to provide padding and protection for 2nd degree burns, diabetic wounds (primarily lower leg and foot), surgical wounds (left to heal by secondary intention and incisional wounds) and skin abrasions. The dressings are suitable for use under compression bandaging.
Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.
- 2010-04-08TerminatedError in labeling
Aplicare Advantage Dressing Change System, Central Line Dressing Change, Sterile Part number: A3402. The product is used for Central Line Dressing Change.
Incorrect expiration date on outer kit label-extended.
- 2004-07-20TerminatedOther
Kendall Kerlix A.M.D. Antimicrobial Large Roll, Sterile 6 ply-4.5 in x 4.1 yd Product Number: 3331
Sterility compromised due to lack of package seal integrity
- 2004-07-20TerminatedOther
Kendall Kerlix Large Roll, 4.5 in X 4.1 yd, Sterile Product Number: 6730
Sterility compromised due to lack of package seal integrity
- 2004-07-20TerminatedOther
Kendall Curity Disposable Laparotomy Sponges, 12 in x 12 in, Sterile Product Number: 6034
Sterility compromised due to lack of package seal integrity
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