Medline DYNJP3008UGRecalls & reported problems
Medline Industries, Inc. · DRAPE,LAPAROTOMY,PCH ULTRAGARD · Class 2
Data updated Oct 16, 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10080196573783), received between Apr 7, 2026 and Apr 7, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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 16, 2026.
Reports received per month
Recalls naming this device
- Jan 7, 2026Open, Classified
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Z-2128-2026 · Root cause: Process control · Recall details · FDA record ↗
- Jan 7, 2026Open, Classified
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Z-1423-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Wound Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 7, 2026Insufficient Device Problem Information
"SHORTLY AFTER THE SURGERY, THE OWNER BEGAN SHARING CONCERNS SURROUNDING THE INCISION SITE, STARTING WITH SMALL OOZING AT THE CRANIAL EDGE, TO A WIDESPREAD INFECTION ALONG THE ENTIRE SITE."
Patient problems: Wound Infection
MAUDE report 24808799 ↗
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 DYNJP2416Medline Industries, Inc. · Drape, surgical2 recalls1 report
- Medline DYNJP4003Medline Industries, Inc. · Drape, surgical2 recalls0 reports
- Medline DYNJP2418Medline Industries, Inc. · Drape, surgical2 recalls0 reports
- Medline Industries, Inc. SPTPCD10005Medline 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 · each recall links to the FDA recall notice
- 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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