Zip 4 Surgical Skin Closure Device PS2040Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00853114007195), received between May 12, 2021 and Jan 23, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (3 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Difficult to Open or Close

  NO CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24164261 ↗
• MalfunctionOct 28, 2025Biocompatibility; Biocompatibility

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: BIOCOMPATIBILITY. 1 EVENT HAD MINOR INJURY/ILLNESS/IMPAIRMENT.

  Patient problems: Blister; Skin Inflammation/ Irritation

  MAUDE report 23399947 ↗
• MalfunctionOct 28, 2025Difficult to Open or Close; Difficult to Open or Close

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DIFFICULT TO OPEN OR CLOSE. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399790 ↗
• MalfunctionJan 21, 2025Difficult to Open or Close; Difficult to Open or Close

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY DIFFICULT TO OPEN OR CLOSE. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200858 ↗
• MalfunctionOct 22, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY HAD A LOSS OF OR FAILURE TO BOND. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504472 ↗
• InjuryMay 12, 2021Biocompatibility; Biocompatibility

  THE USER FACILITY REPORTED THAT THE DEVICE WAS DELAMINATING SKIN UPON REMOVAL.  PATIENT WAS REFERRED TO A DERMATOLOGIST WHERE A STEROID WAS GIVEN TO HELP HEAL THE DELAMINATION. HOWEVER UPON A LATER VISIT TO THE SURGEON THE STEROID WAS NOT HELPING AND THE REACTION HAD SPREAD SO THE SURGEONS BROUGHT HIM IN FOR AN ADDITIONAL WASH OUT PROCEDURE AND RE-CLOSED THE WOUND. THE PATIENT WAS SEEN AFTER THIS AND SEEMED TO BE HEALING NORMALLY.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 11812040 ↗