Zip 16 Surgical Skin Closure Device PS1160Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00865379000019), received between Sep 1, 2020 and Jan 23, 2026 — classified as 3 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (7 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Loss of or Failure to Bond

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: LOSS OF OR FAILURE TO BOND. 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163972 ↗
• MalfunctionJan 23, 2026Difficult 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 OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: DIFFICULT TO OPEN OR CLOSE. 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 24163113 ↗
• MalfunctionOct 28, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  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 6 EVENTS FOR THE FAILURE: LOSS OF OR FAILURE TO BOND. - 6 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399834 ↗
• MalfunctionOct 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  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 2 EVENTS FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT. - 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399796 ↗
• 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 13 EVENTS FOR THE FAILURE: DIFFICULT TO OPEN OR CLOSE, 3 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399791 ↗
• MalfunctionJul 24, 2025Difficult to Open or Close; Difficult to Open or Close

  THIS REPORT SUMMARIZES 4 EVENTS FOR THE FAILURE: DIFFICULT TO OPEN OR CLOSE. - 4 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587100 ↗
• MalfunctionApr 21, 2025Difficult to Open or Close; Difficult to Open or Close

  THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY DIFFICULT TO OPEN OR CLOSE. 1 EVENT HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 5 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878616 ↗
• MalfunctionApr 21, 2025Loss 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 21878596 ↗
• MalfunctionJan 22, 2025Difficult to Open or Close; Difficult to Open or Close

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY DIFFICULT TO OPEN OR CLOSE. 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207643 ↗
• 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 20504471 ↗
• MalfunctionSep 13, 2024Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WOUND DEHISCENCE UNDERNEATH THE ZIP SURGICAL SKIN CLOSURE DEVICE. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY.

  Patient problems: Insufficient Information; Skin Inflammation/ Irritation

  MAUDE report 20212193 ↗
• MalfunctionJul 25, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER A SURGICAL PROCEDURE USING A ZIP SURGICAL SKIN CLOSURE DEVICE THE PATIENT PRESENTED WITH ACQUIRED HYPERPIGMENTATION. THE PATIENT HAD PREVIOUSLY EXPERIENCED A SIMILAR EVENT WITH ACQUIRED HYPERPIGMENTATION. NO MEDICAL INTERVENTION HAS BEEN REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Hyperpigmentation

  MAUDE report 19833429 ↗
• MalfunctionJun 28, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  THE CUSTOMER REPORTED THAT THE ADHESIVE WAS NOT STICKY ENOUGH TO USE DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW DEVICE WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19637726 ↗
• MalfunctionJan 22, 2024Difficult to Open or Close; Difficult to Open or Close

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY DIFFICULT TO OPEN OR CLOSE. - 4 EVENTS REQUIRED THE USE OF AN ADDITIONAL OR ALTERNATIVE DEVICE TO ACHIEVE OPTIMAL OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18557268 ↗
• InjuryOct 11, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE ZIP DEVICE WAS USED TO CLOSE THE WOUND AFTER THE PATIENT'S TOTAL KNEE REPLACEMENT. THE ZIP WAS REMOVED FROM THE PATIENT THREE DAYS EARLY DUE TO AN ALLERGIC REACTION. PATIENT DEVELOPED A RASH ON THE WOUND SITE, HAD ITCHING, AND WAS HAVING DIFFICULTY SWALLOWING.

  Patient problems: Dysphagia/ Odynophagia; Dysphasia; Hypersensitivity/Allergic reaction; Itching Sensation; Rash

  MAUDE report 17914844 ↗
• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT THE ZIP DEVICE CAUSED A REACTION ON HER SKIN THAT WAS OBSERVED UPON REMOVAL. THERE WAS A PAINFUL REDNESS THAT REMAINED ON THE SKIN FOR A MONTH BEFORE FADING. USED OVER THE COUNTER OINTMENT TO HELP TREAT THE REACTION.

  Patient problems: Skin Burning Sensation; Skin Inflammation/ Irritation

  MAUDE report 16354178 ↗
• InjuryOct 8, 2021Difficult to Open or Close; Difficult to Open or Close

  THE USER FACILITY REPORTED THAT THE DEVICE WAS NOT CLOSING THE WOUND AFTER A PROCEDURE. THE ZIP WAS REMOVED AND THE WOUND REQUIRED SUTURES TO BE USED. NO OTHER ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Wound Dehiscence

  MAUDE report 12601479 ↗
• MalfunctionNov 24, 2020Biocompatibility; Biocompatibility

  THE USER FACILITY REPORTED THAT THE PATIENT DEVELOPED A RASH AFTER USING THE BANDAGE. PATIENT WAS GIVEN ANTIBIOTICS TO TREAT RASH. NO FURTHER ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: Rash

  MAUDE report 10896784 ↗
• MalfunctionSep 2, 2020Patient-Device Incompatibility; Biocompatibility; Patient-Device Incompatibility; Biocompatibility

  THE USER FACILITY REPORTED THAT BLISTERS FORMED UNDER THE DEVICE AFTER A PROCEDURE. THE BLISTERS CRACKED AND HEALED AND THE USER FACILITY REPORTED NO FURTHER ISSUE AFTER THEY HEALED.

  Patient problems: Blister; Reaction

  MAUDE report 10482173 ↗
• MalfunctionSep 1, 2020Patient-Device Incompatibility; Biocompatibility; Patient-Device Incompatibility; Biocompatibility

  THE USER FACILITY REPORTED THAT BLISTERS FORMED UNDER THE DEVICE AFTER A PROCEDURE. THE BLISTERS CRACKED AND HEALED AND THE USER FACILITY REPORTED NO FURTHER ISSUE AFTER THEY HEALED.

  Patient problems: Blister; Reaction

  MAUDE report 10479658 ↗