Ioban™ 2 6661EZRecalls & reported problems
3m Company · 3M™ Ioban™ 2 Antimicrobial Incise Drape 6661EZ · Class 2
All models of Ioban 2 (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30707387567164), received between Sep 18, 2019 and Sep 18, 2019 — classified as 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Increased Sensitivity1
- Injury1
- Pain1
- Skin Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FEMALE PATIENT WITH PARCHMENT SKIN HAD A TOTAL SHOULDER PROSTHESIS AND ALLEGEDLY EXPERIENCED LARGE SKIN LESIONS WITH PAIN WHEN A 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE WAS REMOVED THAT WAS PLACED FROM THE FRONT UPPER ARM TO THE BREAST. THE LESIONS WERE REPORTED TO BE ABOUT 15X10CM VENTRAL AND 10X8CM DORSAL OF SUPERFICIAL NATURE. TREATMENT INCLUDED REGULAR DRESSING CHANGES PERFORMED WITHOUT ANESTHESIA. HYPERESTHESIA IN THE AREA OF THE SKIN LESIONS WAS ALSO OBSERVED. BANDAGES WERE CHANGED DAILY. THE SKIN HEALED IN (B)(6) 2019.
Patient problems: Increased Sensitivity; Injury; Pain; Skin Irritation
MAUDE report 9083081 ↗
Other Drape, surgical devices
- Medline DYNJP2414RMedline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP2410Medline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP2411Medline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP8002Medline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP3008UGMedline Industries, Inc. · Drape, surgical2 recalls1 report
- Medline DYNJP2416Medline Industries, Inc. · Drape, surgical2 recalls1 report
- Medline DYNJP4003Medline Industries, Inc. · Drape, surgical2 recalls0 reports
- Medline DYNJP2418Medline Industries, Inc. · Drape, surgical2 recalls0 reports
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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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