DERMABOND PRINEORecalls & reported problems across all models

We found 4 models of DERMABOND PRINEO by Ethicon, LLC in the FDA's device registry (GUDID). Together they are named in 1,099 adverse event reports in the FDA's MAUDE database, received between Nov 29, 2017 and Sep 29, 2026 — classified as 981 injuries, 118 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (70 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. 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

Most reported DERMABOND PRINEO problems

DERMABOND PRINEO models

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

• DERMABOND PRINEO CLR222US

  Cutaneous tissue adhesive with mesh
  790 reports
• DERMABOND PRINEO CLR222

  Cutaneous tissue adhesive with mesh
  183 reports
• DERMABOND PRINEO CLR602US

  Cutaneous tissue adhesive with mesh
  80 reports
• DERMABOND PRINEO CLR422US

  Cutaneous tissue adhesive with mesh
  46 reports

Recent DERMABOND PRINEO adverse event reports

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

• InjurySep 29, 2026Material Separation; Adverse Event Without Identified Device or Use Problem

  Patient problems: Necrosis

  MAUDE report 50938660 ↗
• InjurySep 29, 2026Material Separation; Adverse Event Without Identified Device or Use Problem

  Patient problems: Necrosis

  MAUDE report 50938647 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  Title: Formaldehyde Emissions From 2-Octyl Cyanoacrylate: Quantified Risk for Allergic Contact Dermatitis. The aim of this study is to quantify the amount of formaldehyde emitted from 2-octyl cyanoacrylate (OCA) adhesives and to assess the risk that these formaldehyde emissions could contribute to allergic contact dermatitis (ACD) in exposed patients. Dermabond Prineo (ETH) was used for skin closure of surgical incisions after surgery.Reported Complications:Demabond Prineo (ETH)Allergic Contact Dermatitis (ACD) (n=?)Treatment: not reportedErythema (n=?)Treatment: not reportedEdema (n=?)Treatment: not reportedVesicles/blister formation (n=?)Treatment: not reportedSystemic erythema (n=?)Treatment: not reportedIncreased risk of surgical site infection (SSI) secondary to hypersensitivity reactions (n=?)Treatment: not reportedIn conclusion, 2-octyl-cyanoacrylate-mesh-systems emit formaldehyde at levels exceeding sensitization and inhalation thresholds, raising concern for dermal and respiratory exposure, particularly in sensitised individuals. Prior sensitisation from adhesives such as nail, eyelash or super glues may heighten risk.

  Patient problems: Blister; Erythema; Hypersensitivity/Allergic reaction; Local Reaction; Swelling/ Edema; Unspecified Infection

  MAUDE report 50717466 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a hardware removal knee procedure on an unknown date and a topical skin adhesive was used. It was reported by the Orthopedic PA that a patient having a tension blister 10 days ago when utilizing the topical skin adhesive. The adhesive was removed in the office and prescription strength Benadryl was given. Additional information was requested.

  Patient problems: Blister

  MAUDE report 50717410 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent an unknown procedure and topical skin adhesive was used. The patient has already used the product in previous surgery without any reaction, indicating unprecedented sensitivity at this time. Chronology: (b)(6) 2026: Surgery with application of the product in the incision. (b)(6) 2026: Early erythema and severe itching on site. No improvement with oral antiallergic. (b)(6) 2026: Reaction became systemic by the body. Emergency care with intravenous and intramuscular medication. Severe allergic rebound occurred after 8h, requiring new emergency care. Current situation: Local injury (burning aspect). The surgeon removed the glue mechanically. Due to the severity of the skin, it was necessary to follow up with a dermatologist. The patient follows treatment to contain the allergy being accompanied by surgeon and dermatologist. No additional information was provided.

  Patient problems: Burn(s); Erythema; Hypersensitivity/Allergic reaction; Itching Sensation

  MAUDE report 50549722 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. The patient experienced delayed wound healing. They may have had to reoperate to revise the incision. Additional information was requested.

  Patient problems: Impaired Healing

  MAUDE report 50369731 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. The patient experienced delayed wound healing. They may have had to reoperate to revise the incision. Additional information was requested.

  Patient problems: Impaired Healing

  MAUDE report 50369705 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a patient underwent an unknown procedure on an unknown date in (b)(6) 2026 and topical skin adhesive was used. A reaction occurred. He said this was on a middle-aged woman with no known adhesive allergies. They used the proper screening prior, and the adhesive was applied properly. Reaction started under the adhesive then later spread and blistered around the mesh. Oral steroid was taken and cleared up the reaction. No image to provide. The device was not returning. Additional information has been requested.

  Patient problems: Blister; Skin Inflammation/ Irritation

  MAUDE report 50069510 ↗
• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. THE CUSTOMER REPORTED A SEVERE SKIN REACTION TO THE APPLICATION OF ADHESIVE. PRESCRIBED ANTIHISTAMINES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 25488138 ↗
• MalfunctionJun 8, 2026Device Contaminated During Manufacture or Shipping; Material Integrity Problem

  IT WAS REPORTED UPON OPENING ON 4-MAR-2026 THE TOPICAL SKIN ADHESIVE HAD AN ISSUE. OPENED BOX AND OBSERVED THAT UNIT WAS LEAKING THROUGH THE PACKAGING. ONE OF THE PACKETS APPEAR TO BE GROWING SOMETHING INSIDE THE GLUE TUBE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25427761 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A RIGHT ROBOTICALLY ASSISTED TOTAL KNEE ARTHROPLASTY ON (B)(6) 2025 AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT HAD AN ADVERSE REACTION TO ADHESIVE. SHE WAS GIVEN A SCRIPT FOR ANTIHISTAMINES AND PAIN RELIEF. SHE WENT HOME WITH MEPITEL AND LEUKOMED SORBACT DRESSINGS AS THIS IS THE USUAL TREATMENT FOR REACTION. SHE HAD OOZE ALMOST BREACHING THROUGH THE DRESSING WE CHANGED HER DRESSING TO MEPITEL AND SORBION SORBACT. PATIENT WAS GIVEN PREDNISONE AT THIS POINT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Fluid Discharge; Skin Inflammation/ Irritation

  MAUDE report 25374994 ↗
• MalfunctionMay 29, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED UPON OPENING TOPICAL SKIN ADHESIVE ON AN UNKNOWN DATE IN 2026. A YELLOW STAIN FOUND ON PRODUCTS. ITEM WERE NOT USED ON PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337456 ↗
• MalfunctionMay 29, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED UPON OPENING TOPICAL SKIN ADHESIVE ON AN UNKNOWN DATE IN 2026. A YELLOW STAIN FOUND ON PRODUCTS. ITEM WERE NOT USED ON PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337453 ↗
• MalfunctionMay 29, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED UPON OPENING TOPICAL SKIN ADHESIVE ON AN UNKNOWN DATE IN 2026. A YELLOW STAIN FOUND ON PRODUCTS. ITEM WERE NOT USED ON PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337450 ↗
• MalfunctionMay 29, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED UPON OPENING TOPICAL SKIN ADHESIVE ON AN UNKNOWN DATE IN 2026. A YELLOW STAIN FOUND ON PRODUCTS. ITEM WERE NOT USED ON PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337448 ↗

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