Dressing, Wound, Hydrophilic
FDA adverse event reports and recall history for dressing, wound, hydrophilic (product code NAC), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,337
- Deaths
- 6
- Injuries
- 302
- Malfunctions
- 1,023
Reports per year
Source: FDA adverse event reports by year received, 2010–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-06-03Open, ClassifiedUnder Investigation by firm
DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Sterile wound dressing, lacks sterility assurance
- 2025-04-04Open, ClassifiedUnder Investigation by firm
Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93", 2) Model Number: MJ18004, DBD-MEIJER,BANDAGE,HYDROCOLLOID,HEEL,OVL 3) Model Number: MJ18005, MEIJER,BANDAGE,HYDROCOLLOID,ALLPURP,10CT 4) Model Number: MJ76126V1, DBD-MEIJER,HYDROCOLLOID,FINGER&TOE,8CT 5) Model Number: RA0353818V1, BANDAGE,BLISTER, RITEAID,6EA/BX, 24BX/CS
There is a potential for the sterility of the device to be compromised.
- 2024-12-04Open, ClassifiedPackaging process control
Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic and acute wounds such as: pressure ulcers leg ulcers cavity wounds lacerations post-operative surgical wounds
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
- 2024-12-04Open, ClassifiedPackaging process control
McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
- 2024-12-04Open, ClassifiedPackaging process control
MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048EP Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
- 2024-04-08Open, ClassifiedUnder Investigation by firm
ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/market unit.
The product does not meet sterility assurance level.
- 2024-03-14Open, ClassifiedUnder Investigation by firm
CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4 in., 4 dressings per box, 24 boxes per case.
Product failed sterility testing.
- 2016-12-08TerminatedMaterial/Component Contamination
AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150
The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling and analysis.
- 2004-02-24TerminatedOther
Multidex Powder, Maltodextrin Wound Dressing, Catalog Numbers: 46-701, 46-702, 46-703, 46-704, 46-702-1, 46-703-1, 46-704-1; Type of Packaging: Tubes, dispenser box
Hydrophilic powder wound dressing, sterilized at a dosage which subsequently failed a sterility audit, was distributed.
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