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ZipSeal 16 Surgical Skin Closure Kit PS1163Recalls & reported problems

Stryker Corporation · ZipSeal 16 Surgical Skin Closure Kit · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00853114007225), received between Oct 28, 2020 and Oct 28, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

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.

Most reported problems

Device problems

  • Biocompatibility1

Patient problems

  • Blister1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 28, 2020Biocompatibility; Biocompatibility

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY CAUSED A TISSUE REACTION WITH THE PATIENT. 1 EVENT WHICH HAD A MILD INJURY, ILLNESS OR IMPAIRMENT WHICH CAN BE TREATED WITH MINIMAL OR NO INTERVENTION.

    Patient problems: Blister

    MAUDE report 10748482 ↗

Other Wound Dressing Kit devices

All Wound Dressing Kit devices →

Sources and updates

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