Medline Industries, Inc. DYNJ32253GRecalls & reported problems
Medline Industries, Inc. · CUH C-SECTION PACK-LF · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10195327066536), received between Aug 11, 2026 and Sep 24, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (3 reports).
2 FDA recall records name this device's identifier, 2 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.
Reports received per month
Recalls naming this device
- Oct 9, 2024Class IIOpen, Classified
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Z-0645-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Nov 17, 2022Class IIOpen, Classified
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Z-1092-2023 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Leak/Splash3
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Fluid/Blood Leak
It was reported that "UTSW is having major issues with the c- section drape leaking" and the "Issue: Leaking where pouch and clear incise area is."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877382 ↗MalfunctionAug 13, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50241573 ↗MalfunctionAug 12, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50226765 ↗MalfunctionAug 11, 2026Leak/Splash
It was reported that "The drape is leaking fluid."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50214501 ↗
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- Medline Industries, Inc. DYNJ904653GMedline Industries, Inc. · Cesarean section tray3 recalls0 reports
- Medline Industries, Inc. DYNJ15494GMedline Industries, Inc. · Cesarean section tray3 recalls0 reports
- Medline Industries, Inc. DYNJ33059BMedline Industries, Inc. · Cesarean section tray3 recalls0 reports
- 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 · 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.
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