Medline Industries, Inc. DYNJ81496BRecalls & reported problems
Medline Industries, Inc. · OCHSNER C SECTION SYS · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10198459083402), received between Aug 12, 2026 and Aug 17, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Adhesive Too Strong” (4 reports).
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.
Reports received per month
Most reported problems
Device problems
- Adhesive Too Strong4
- Material Separation1
Patient problems
- Skin Tears3
- No Clinical Signs, Symptoms or Conditions2
- Skin Inflammation/ Irritation2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2026Adhesive Too Strong
Surgical drape stuck to patients skin when trying to remove it after case was finished, when removing skin drape it was "glued" to the patients skin and we had to exert force to get it off which resulted in patients skin being pulled off with the drape.
Patient problems: Skin Tears
MAUDE report 50274852 ↗MalfunctionAug 14, 2026Adhesive Too Strong
Patient problems: Skin Inflammation/ Irritation; Skin Tears
MAUDE report 50255632 ↗MalfunctionAug 14, 2026Adhesive Too Strong
According to the facility contact, "surgical drape stuck to patient's skin when trying to remove it after case was finished" and "when removing skin drape, it was "glued" to the patient's skin and we had to exert force to get it off." Per the customer contact, this "resulted in patient's skin being pulled off with the drape in some areas and a sticky residue left in other spots."
Patient problems: Skin Inflammation/ Irritation; Skin Tears
MAUDE report 50252870 ↗MalfunctionAug 12, 2026Material Separation
It was reported that the fluid collection pouch on the C - section drape separated from the drape when opened.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228849 ↗MalfunctionAug 12, 2026Adhesive Too Strong
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50226542 ↗
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- Medline Industries, Inc. DYNJ47808FMedline Industries, Inc. · Cesarean section tray3 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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