SUR-FIT NATURARecalls & reported problems across all models

We found 43 models of SUR-FIT NATURA by Convatec, Purchasing Department in the FDA's device registry (GUDID). Together they are named in 6,207 adverse event reports in the FDA's MAUDE database, received between Oct 30, 2018 and Jun 4, 2026 — classified as 39 injuries, 6,168 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (6,054 reports).

2 FDA recall records name at least one of these models by its device identifier, 1 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

SUR-FIT NATURA recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 17, 2024Open, Classified

   The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.

   Z-1276-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗

2. Apr 22, 2022Terminated

   Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.

   Z-1134-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported SUR-FIT NATURA problems

SUR-FIT NATURA models

43 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SUR-FIT NATURA 413182

  PROTECTOR, OSTOMY
  1,202 reports
• SUR-FIT NATURA 413180

  PROTECTOR, OSTOMY
  1,190 reports
• SUR-FIT NATURA 413179

  PROTECTOR, OSTOMY
  1,178 reports
• SUR-FIT NATURA 413181

  PROTECTOR, OSTOMY
  974 reports
• SUR-FIT NATURA 413183

  PROTECTOR, OSTOMY
  773 reports
• SUR-FIT NATURA 413184

  PROTECTOR, OSTOMY
  153 reports
• SUR-FIT NATURA 421040

  Protector, Ostomy
  146 reports
• SUR-FIT NATURA 413418

  Protector, Ostomy
  97 reports
• SUR-FIT NATURA 413178

  PROTECTOR, OSTOMY
  80 reports
• SUR-FIT NATURA 125273

  Protector, Ostomy
  64 reports
• SUR-FIT NATURA 413419

  Protector, Ostomy
  62 reports
• SUR-FIT NATURA 421034

  Protector, Ostomy
  53 reports
• SUR-FIT NATURA 413157

  Protector, Ostomy
  1 recall0 reports
• SUR-FIT NATURA 416938

  Bag, Drainage, With Adhesive, Ostomy
  1 recall0 reports
• SUR-FIT NATURA 421041

  Protector, Ostomy
  32 reports
• SUR-FIT NATURA 421035

  Protector, Ostomy
  30 reports
• SUR-FIT NATURA 125269

  PROTECTOR, OSTOMY
  27 reports
• SUR-FIT NATURA 413185

  PROTECTOR, OSTOMY
  21 reports
• SUR-FIT NATURA 401514

  Bag, drainage, with adhesive, ostomy
  20 reports
• SUR-FIT NATURA 125270

  PROTECTOR, OSTOMY
  19 reports
• SUR-FIT NATURA 125265

  PROTECTOR, OSTOMY
  11 reports
• SUR-FIT NATURA 125271

  Protector, Ostomy
  9 reports
• SUR-FIT NATURA 413188

  PROTECTOR, OSTOMY
  8 reports
• SUR-FIT NATURA 125260

  PROTECTOR, OSTOMY
  7 reports
• SUR-FIT NATURA 401502

  Bag, drainage, with adhesive, ostomy
  7 reports
• SUR-FIT NATURA 125274

  PROTECTOR, OSTOMY
  6 reports
• SUR-FIT NATURA 421033

  Protector, Ostomy
  6 reports
• SUR-FIT NATURA 401513

  Bag, drainage, with adhesive, ostomy
  5 reports
• SUR-FIT NATURA 413417

  Protector, Ostomy
  4 reports
• SUR-FIT NATURA 401544

  BAG, URINARY, ILEOSTOMY
  3 reports
• SUR-FIT NATURA 401933

  Bag, drainage, with adhesive, ostomy
  3 reports
• SUR-FIT NATURA 125259

  PROTECTOR, OSTOMY
  2 reports
• SUR-FIT NATURA 125263

  Protector, Ostomy
  2 reports
• SUR-FIT NATURA 125272

  Protector, Ostomy
  2 reports
• SUR-FIT NATURA 413154

  PROTECTOR, OSTOMY
  2 reports
• SUR-FIT NATURA 421039

  Protector, Ostomy
  2 reports
• SUR-FIT NATURA 125266

  PROTECTOR, OSTOMY
  1 report
• SUR-FIT NATURA 125277

  PROTECTOR, OSTOMY
  1 report
• SUR-FIT NATURA 413156

  PROTECTOR, OSTOMY
  1 report
• SUR-FIT NATURA 413160

  PROTECTOR, OSTOMY
  1 report
• SUR-FIT NATURA 413161

  PROTECTOR, OSTOMY
  1 report
• SUR-FIT NATURA 413167

  Protector, Ostomy
  1 report
• SUR-FIT NATURA 413423

  Protector, Ostomy
  1 report

Recent SUR-FIT NATURA adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25390309 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25390308 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25390306 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25390218 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25390215 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25390213 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25390212 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25390211 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25389671 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25389667 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25389666 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25389665 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25389664 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25389663 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25389661 ↗

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