Zip 24 Surgical Skin Closure Device PS1240Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00865379000033), received between Feb 8, 2019 and Jul 22, 2026 — classified as 15 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (10 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2026Biocompatibility

  Patient problems: Blister; Skin Inflammation/ Irritation

  MAUDE report 25907371 ↗
• 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 1 EVENT FOR THE FAILURE: LOSS OF OR FAILURE TO BOND. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163982 ↗
• MalfunctionJan 23, 2026Biocompatibility; Adverse Event Without Identified Device or Use Problem

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2025. THIS REPORT SUMMARIZES 4 EVENTS FOR THE FAILURES: BIOCOMPATIBILITY; ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM. - 4 EVENTS HAD MINOR INJURY/ILLNESS/IMPAIRMENT.

  Patient problems: Laceration(s); Skin Inflammation/ Irritation

  MAUDE report 24163753 ↗
• MalfunctionJan 23, 2026Biocompatibility

  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 1 EVENT FOR THE FAILURE: BIOCOMPATIBILITY. - 1 EVENT HAD MINOR INJURY/ILLNESS/IMPAIRMENT.

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 24163600 ↗
• 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 8 EVENTS FOR THE FAILURE: DIFFICULT TO OPEN OR CLOSE. 8 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399799 ↗
• 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 1 EVENT FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399798 ↗
• MalfunctionOct 23, 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 1 EVENT FOR THE FAILURE: LOSS OF OR FAILURE TO BOND. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368917 ↗
• MalfunctionJul 30, 2025Biocompatibility; Biocompatibility

  THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: BIOCOMPATIBILITY. 1 EVENT HAD INSUFFICIENT INFORMATION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22663291 ↗
• MalfunctionJul 29, 2025Difficult to Open or Close; Difficult to Open or Close

  NO CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22648101 ↗
• MalfunctionApr 21, 2025Difficult to Open or Close; Difficult to Open or Close

  THIS REPORT SUMMARIZES 7 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY DIFFICULT TO OPEN OR CLOSE. 2 EVENTS 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 21878597 ↗
• MalfunctionJan 21, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD A LOSS OF OR FAILURE TO BOND. 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200139 ↗
• MalfunctionOct 22, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  THIS REPORT SUMMARIZES 8 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD A LOSS OF OR FAILURE TO BOND. 8 EVENTS HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504473 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED AT THE EMERGENCY ROOM WITH EXCESSIVE BLEEDING FOLLOWING A TOTAL KNEE REPLACEMENT ARTHROSCOPY PROCEDURE USING THE ZIP SURGICAL SKIN CLOSURE DEVICE. THE DRESSING WAS CHANGED, AND THE PATIENT WAS RELEASED FROM THE EMERGENCY ROOM. THERE WERE NO OTHER ADVERSE CONSEQUENCES OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19911680 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED IN-OFFICE WITH EXCESSIVE BLEEDING POST-OP (2 DAYS) USING A ZIP SURGICAL SKIN CLOSURE DEVICE. THE DOCTOR CHANGED THE PATIENTS DRESSING AND OBSERVED THE ZIP DEVICE WAS ADHERED AS EXPECTED AND NO MALFUNCTIONS OF THE DEVICE WERE NOTED. THE ZIP DEVICE WAS LEFT ON THE PATIENT AND THE DRESSING WAS CHANGED. THE PATIENT WAS REPORTED TO HAVE FACTOR 5, A BLOOD CLOTTING DISORDER. NO ADDITIONAL ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19911659 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED AT THE EMERGENCY ROOM WITH EXCESSIVE BLEEDING FOLLOWING A TOTAL KNEE REPLACEMENT ARTHROSCOPY PROCEDURE USING THE ZIP SURGICAL SKIN CLOSURE DEVICE. THE DRESSING WAS CHANGED, AND THE PATIENT WAS RELEASED FROM THE EMERGENCY ROOM. THERE WERE NO OTHER ADVERSE CONSEQUENCES OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19911602 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED AT THE EMERGENCY ROOM WITH EXCESSIVE BLEEDING FOLLOWING A TOTAL KNEE REPLACEMENT ARTHROSCOPY PROCEDURE USING THE ZIP SURGICAL SKIN CLOSURE DEVICE. THE DRESSING WAS CHANGED, AND THE PATIENT WAS RELEASED FROM THE EMERGENCY ROOM. THERE WERE NO OTHER ADVERSE CONSEQUENCES OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19911549 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 3-4 DAYS AFTER A SURGICAL PROCEDURE USING THE ZIP SURGICAL CLOSURE DEVICE THE PATIENT PRESENTED AT THE EMERGENCY ROOM WITH EXCESSIVE BLEEDING, THE PATIENT WAS ADMITTED AND TREATED WITH TRANEXAMIC ACID AND THE DRESSING WAS CHANGED OVER THE SURGICAL SITE. THE PATIENT REPORTEDLY HAS FACTOR 5, A BLOOD CLOTTING DISORDER. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19911333 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED AT THE EMERGENCY ROOM WITH EXCESSIVE BLEEDING FOLLOWING A TOTAL KNEE REPLACEMENT ARTHROSCOPY PROCEDURE USING THE ZIP SURGICAL SKIN CLOSURE DEVICE. THE DRESSING WAS CHANGED, AND THE PATIENT WAS RELEASED FROM THE EMERGENCY ROOM. THERE WERE NO OTHER ADVERSE CONSEQUENCES OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19911314 ↗
• MalfunctionAug 1, 2024Loss of or Failure to Bond; Material Integrity Problem; Loss of or Failure to Bond; Material Integrity Problem

  THE CUSTOMER REPORTED THAT AFTER USING A ZIP SURGICAL SKIN CLOSURE DEVICE THE DEVICE LOST ADHESION AND THE ZIPPER TORE FROM THE ADHESIVE. THERE WERE NO REPORTED DELAYS, MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19889568 ↗
• InjuryJul 2, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT 2-3 DAYS POST OP THE PATIENT PRESENTED WITH THE ZIP DEVICE RIPPING AND SLIPPING OUT OF PLACE. THE DEVICE WAS REMOVED, AND A NEW DEVICE WAS PLACED OVER THE SURGICAL SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660827 ↗
• InjuryJul 2, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT 2-3 DAYS POST OP THE PATIENT PRESENTED WITH THE ZIP DEVICE RIPPING AND SLIPPING OUT OF PLACE. THE DEVICE WAS REMOVED, AND A NEW DEVICE WAS PLACED OVER THE SURGICAL SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660567 ↗
• InjuryJul 2, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT 2-3 DAYS POST OP THE PATIENT PRESENTED WITH THE ZIP DEVICE RIPPING AND SLIPPING OUT OF PLACE. THE DEVICE WAS REMOVED, AND A NEW DEVICE WAS PLACED OVER THE SURGICAL SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660564 ↗
• InjuryAug 12, 2022Loss of or Failure to Bond; Difficult to Open or Close; Loss of or Failure to Bond; Difficult to Open or Close

  THE USER FACILITY REPORTED THAT THE DEVICE LOST ADHESION ON THE WOUND AFTER A PROCEDURE. PORTION OF THE ZIP DEVICE HAD TO BE REMOVED AND REPLACED WITH SUTURES.

  Patient problems: Wound Dehiscence

  MAUDE report 15221686 ↗
• InjuryAug 18, 2021Biocompatibility; Biocompatibility

  THE USER FACILITY REPORTED THAT THE DEVICE WAS CAUSING IRRITATION AND BLISTERING DURING A CHECK UP AFTER A PROCEDURE.  PATIENT'S ZIP DEVICE WAS REMOVED AND WAS REPLACED WITH STERISTRIPS AT 2 WEEKS RATHER THAN THE PLANNED 3 WEEKS FOR REMOVAL. PATIENT'S WOUND AND BLISTERING IS HEALING WELL.

  Patient problems: Blister; Skin Inflammation/ Irritation

  MAUDE report 12338979 ↗
• InjuryAug 11, 2021Biocompatibility; Biocompatibility

  THE USER FACILITY REPORTED THAT THE PATIENT HAD A BLISTER REACTION FROM THE ZIP DEVICE UPON REMOVAL POST PROCEDURE. PATIENT HAD PAIN AND BURNING WITH THE REACTION. PATIENT WAS TREATED WITH A PRESCRIPTION ANTIBIOTICS AND TOPICAL OINTMENT TO TREAT CELLULITIS AND PREVENT INFECTION. PATIENT ALSO HAD A FEVER. PATIENT WAS HEALING WELL SINCE THE LAST FOLLOW UP VISIT.

  Patient problems: Bacterial Infection; Blister; Fever

  MAUDE report 12309339 ↗