ONFLEXRecalls & reported problems across all models

We found 4 models of ONFLEX by Davol Inc. in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Dec 18, 2017 and Jun 17, 2026 — classified as 14 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (4 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 ONFLEX problems

ONFLEX models

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

• ONFLEX 0115410

  Mesh, surgical, polymeric
  9 reports
• ONFLEX 0115610

  Mesh, surgical, polymeric
  8 reports
• ONFLEX 0115411

  Mesh, surgical, polymeric
  3 reports
• ONFLEX 0115611

  Mesh, surgical, polymeric
  2 reports

Recent ONFLEX adverse event reports

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

• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  PER JOURNAL ARTICLE: "FIRST EVALUATION OF THE TREPP PROCEDURE FOR INGUINOSCROTAL HERNIA REPAIR: A STEP-UP STUDY" THE AIM OF THIS STUDY IS TO EVALUATE THE CLINICAL OUTCOME OF THE TREPP PROCEDURE SPECIFICALLY IN THE TREATMENT OF SCROTAL HERNIAS. TRANSRECTUS SHEATH PRE-PERITONEAL (TREPP) MESH REPAIR. THIS RETROSPECTIVE STUDY ANALYZED CONSECUTIVE PATIENTS WHO UNDERWENT TREPP REPAIR FOR SCROTAL HERNIA BETWEEN JANUARY 2021 AND DECEMBER 2023. EITHER A MEDIUM (8.6CMX14.2CM) OR A LARGE (10.2CMX15.7CM) ONFLEX¿ MESH WAS USED, DEPENDING ON THE SIZE OF THE PREPERITONEAL SPACE. A TOTAL OF 33 PRIMARY SCROTAL HERNIA CASES WERE ANALYZED AND TREATED WITH THE TREPP PROCEDURE. OF THESE, 33 PROCEDURES WERE PERFORMED FOR A PRIMARY SCROTAL HERNIA, ONE PATIENT WAS TREATED BECAUSE OF RECURRENT SCROTAL HERNIA AND WAS EXCLUDED FROM FURTHER ANALYSIS NO RECURRENCE WAS REPORTED WITHIN THIS TIMEFRAME. COMPLICATIONS WERE MINIMAL, WITH ONLY ONE PATIENT (3.0%) DEVELOPING NEUROPATHIC PAIN DUE TO ACNES, WHICH WAS RESOLVED COMPLETELY AFTER APPROPRIATE LOCAL INJECTIONS (NOT RELATED TO THE IMPLANT). TWO PATIENTS (6.1%) EXPERIENCED SUPERFICIAL INFECTIONS THAT WERE SUCCESSFULLY MANAGED WITH ANTIBIOTICS, AND NO MESH INFECT

  Patient problems: Hematoma; Seroma

  MAUDE report 25537330 ↗
• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  PER JOURNAL ARTICLE: "COMPARISON OF THE ONSTEP AND LICHTENSTEIN TECHNIQUES FOR INGUINAL HERNIA REPAIR-EARLY RESULTS OF A PROSPECTIVE STUDY" THE ARTICLE PRESENTS A STUDY OF 41 MEN RANDOMIZED INTO 2 STUDY GROUPS, UNILATERAL INGUINAL HERNIA REPAIR WAS PERFORMED USING THE ONSTEP TECHNIQUE IN GROUP O AND THE LICHTENSTEIN TECHNIQUE IN GROUP L. A TOTAL OF 34 MEN MET THE FULL INCLUSION CRITERIA, WITH EACH GROUP CONSISTING OF 17 PATIENTS. DATA WERE COLLECTED PROSPECTIVELY DURING HOSPITALIZATION, AS WELL AS ON DAY 7 AND AT 3 AND 12 MONTHS POSTOPERATIVELY. PAIN INTENSITY WAS ASSESSED USING THE NUMERICAL RATING SCALE (NRS). THE SEVERITY OF THE SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (SIRS) WAS EVALUATED BASED ON CHANGES IN THE FOLLOWING PARAMETERS: LEUKOCYTE AND PLATELET COUNTS, LEVELS OF INTERLEUKIN-6, C-REACTIVE PROTEIN (CRP), AND FIBRINOGEN AT 6, 24, 46, AND 168 HOURS POSTOPERATIVELY. POSTOPERATIVE COMPLICATIONS OF THE TECHNIQUES INCLUDED 6 CASE OF LOCAL HEMATOMA ON GROIN (GROUP O N=2, GROUP L N=4), 3 CASE OF LOCAL HEMATOMA ON SCROTAL (GROUP O N=2, GROUP L N=1), 7 CASES WITH SUBCUTANEOUS HEMATOMA (GROUP O N=4 AND GROUP L N=3), 1 CASE OF URINARY RETENTION (GROUP O N=1) (URINARY RETENTION IS

  Patient problems: Hematoma; Pain

  MAUDE report 25530737 ↗
• MalfunctionAug 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, THE MODIFIED ONFLEX MESH WAS NOTED TO BE RUPTURED BEFORE THE PROCEDURE. IT WAS REPORTED THAT THE INNER PACKAGING WAS FOUND TO BE INTACT, AND THE PRODUCT BOX WAS ALSO FULLY SEALED BEFORE IT WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22721484 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER JOURNAL ARTICLE: "TRANS RECTUS SHEATH EXTRA-PERITONEAL PROCEDURE (TREPP) FOR INGUINAL HERNIA REPAIR UNDER LOCAL ANESTHESIA WITH SEDATION IN THE OUTPATIENT CLINIC: A FEASIBILITY STUDY." THE ARTICLE DESCRIBES RETROSPECTIVE FEASIBILITY STUDY WHICH INVESTIGATES THE SAFETY AND EFFICIENCY OF TREPP UNDER LOCAL ANESTHESIA IN THE OUTPATIENT CLINIC IN COMPARISON WITH LICHTENSTEIN BETWEEN 2019 AND 2022. IT WAS PERFORMED EXAMINING 247 PATIENTS (34 PATIENTS IN THE TREPP GROUP AND 213 PATIENTS IN THE LICHTENSTEIN GROUP) WHO UNDERWENT AN ELECTIVE INGUINAL HERNIA REPAIR UNDER LOCAL ANESTHESIA IN THE OUTPATIENT CLINIC OPERATION THEATRE. THE FOLLOWING COMPLICATIONS WAS OBSERVED DURING INGUINAL HERNIA REPAIR FOR TREPP GROUP PATIENTS TREATED WITH ONFLEX MESH HAD INGUINAL HERNIA RECURRENCE WITHIN 8 WEEKS OCCURRED 1 TIME IN THE TREPP GROUP. A SUB-ANALYSIS ON 6-MONTHS RECURRENCE RATE SHOWED 2 HERNIA RECURRENCES IN THE TREPP GROUP, THIS INCLUDES THE RECURRENCE WITHIN 8 WEEKS IN BOTH GROUPS. PAIN WAS PRESENT AFTER 8 WEEKS POST-OPERATIVELY IN (N=3) 8.8% OF THE PATIENTS IN THE TREPP GROUP. WOUND INFECTION, TREPP, N=1(2.9%); HEMATOMA, TREPP, N=5(14.7%); SEROMA, TREPP N=1(2.9%). THE ARTICLE CONCLUDED THAT

  Patient problems: Hematoma; Hernia; Pain; Post Operative Wound Infection; Seroma

  MAUDE report 22510949 ↗
• MalfunctionJun 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, ONFLEX MESH EDGE WAS COMING LOOSE. THERE WAS NO REPORTED PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184488 ↗
• InjuryJun 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF BARD/DAVOL VENTRALEX ST ON (B)(6) 2021, MODIFIED ONFLEX ON (B)(6) 2023 AND 3DMAX MID ON (B)(6) 2024. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL THE DEVICES. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT.¿ IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 22165815 ↗
• MalfunctionAug 1, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, DURING A PROCEDURE, A FOREIGN MATERIAL (HAIR) WAS FOUND WHEN THE MODIFIED ONFLEX MESH PACKAGE WAS OPENED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19885942 ↗
• MalfunctionJun 4, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, ONFLEX MESH CONTAMINATED WITH FOREIGN MATTER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459765 ↗
• MalfunctionDec 19, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING ATTEMPTED IMPLANTATION OF AN ONFLEX MESH, IT WAS NOTED THAT THE ¿RIM WAS GETTING LOOSE¿ AS SUCH ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. CONTACT REPORTS A CLAMP WAS ATTACHED TO THE MESH TO INSERT AND IS UNSURE IF THE CLAMP DAMAGED THE MESH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18354502 ↗
• MalfunctionDec 27, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED ON (B)(6) 2022, UPON OPENING THE BARD/DAVOL MODIFIED ONFLEX MESH PACKAGE, A FOREIGN MATERIAL LIKE HAIR WAS FOUND. IT WAS REPORTED THAT ANOTHER MESH WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16050668 ↗
• InjuryDec 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER JOURNAL ARTICLE IN HERNIA (2021) TITLED, ¿SAFETY AND EFFICACY IN INGUINAL HERNIA REPAIR: A RETROSPECTIVE STUDY COMPARING TREPP, TEP AND LICHTENSTEIN (SETTLE).¿ FEATURED WAS A RETROSPECTIVE COHORT STUDY, 300 PATIENTS OF WHICH 58 (19.3%) UNDERWENT TREPP, 190 (63.3%) TEP AND 52 (17.3%) LICHTENSTEIN WITH BARD/DAVOL ONFLEX, NON-BARD/DAVOL PARIETEX, NON-BARD/DAVOL BIOMESH RESPECTIVELY OVER A PERIOD OF 7 MONTHS FROM MARCH TO SEPTEMBER 2019. THE PRIMARY OUTCOME OF THIS STUDY WAS INGUINAL HERNIA RECURRENCE RATE WITHIN 1 YEAR AFTER SURGERY. SECONDARY OBJECTIVES WERE CHRONIC POST-OPERATIVE INGUINAL PAIN (CPIP) LASTING MORE THAN 6 MONTHS, (MAJOR) COMPLICATION RATES AND OPERATING TIME. THE FOLLOWING COMPLICATIONS WERE OBSERVED FROM 58 PATIENTS TREATED WITH ONFLEX MESH DURING TREPP INGUINAL HERNIA REPAIR: RECURRENCE 2 (1.7%) PATIENTS; CHRONIC PAIN (>6 MONTHS) 1 (1.7%) PATIENT; HEMATOMA (SURGICAL EVACUATION) 5 (8.6%) PATIENTS & WOUND INFECTION 4 (6.9%) PATIENTS. INFORMATION IS PRESENTED WITHOUT PATIENT/CASE SPECIFIC DETAILS.

  Patient problems: Hematoma; Hernia; Pain; Post Operative Wound Infection

  MAUDE report 15978190 ↗
• MalfunctionDec 1, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED ON 09-NOV-2022, UPON OPENING THE BARD/DAVOL MODIFIED ONFLEX MESH PACKAGE, A FOREIGN MATERIAL LIKE HAIR WAS FOUND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15893771 ↗
• MalfunctionDec 7, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, UPON OPENING THE PACKAGE OF THE BARD/DAVOL MODIFIED ONFLEX MESH ON 15-NOV-2021, IT WAS NOTED THAT THE SEALED EDGE WAS PEELED OFF ALL AROUND. AS REPORTED, NO DAMAGE WAS NOTED TO THE OUTER OR INNER PACKAGING. IT WAS REPORTED THAT THE MESH WAS NOT USED ON THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12955100 ↗
• InjuryOct 12, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  AS ALLEGED, THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL ONFLEX MESH. IT WAS REPORTED THAT THE SURGERY TOOK PLACE "TWO YEARS AGO". IT IS ALLEGED THAT THE PATIENT HAS HAD PAIN SINCE SURGERY AND ALLEGEDLY AN MRI SHOWS THE MESH HAS MIGRATED AND IS DAMAGING OTHER AREAS OF THE BODY. AS REPORTED, "THE MESH WILL PROBABLY BE REMOVED AS IT SEEMS TO BE HURTING HIS NERVES AND ONE TESTICLE." AS REPORTED, THE PATIENT'S DOCTOR HAS PROPOSED TO RE-OPERATE. IT IS REPORTED THAT THE PATIENT WANTS TO CONTINUE IN THE PAIN CLINIC AT THIS TIME AND DOES NOT WANT TO UNDERGO RE-OPERATION.

  Patient problems: Nerve Damage; Pain

  MAUDE report 12617287 ↗
• InjuryJul 15, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, FOLLOWING IMPLANT OF A BARD/DAVOL MODIFIED ONFLEX MESH, THE PATIENT EXPERIENCED AN ALLERGIC REACTION AND DEVELOPED URTICARIA ON (B)(6) 2021. AS ALLEGED, THE PATIENT WAS SCHEDULED FOR A HOSPITAL VISIT ON (B)(6) 2021 AND THE MESH IS ALLEGEDLY SCHEDULED TO BE REMOVED ON (B)(6) 2021. ADDENDUM: AS REPORTED, THE PATIENT UNDERWENT REACTIVITY TESTING. AS REPORTED, THE PATIENT WAS ALLERGIC TO IODINE, NEGATIVE TO THE MESH AND SLIGHTLY ALLERGIC TO THE ABSORBABLE RING. IT WAS REPORTED THAT THE MESH REMOVAL WAS SCHEDULED ON (B)(6) 2021; THE SURGERY HAS BEEN POSTPONED (TIME UNDECIDED) BECAUSE THE PATIENT¿S ALLERGIC REACTION SYMPTOMS (URTICARIA, ETC.) IMPROVED BEFORE THE DATE. THE PATIENT IS UNDER OBSERVATION.

  Patient problems: Hypersensitivity/Allergic reaction; Urticaria

  MAUDE report 12177526 ↗

Other Davol Inc. products

• VENTRALEX6 models · 2,360 reports
• PerFix16 models · 1,718 reports
• BARD25 models · 1,538 reports
• VENTRALIGHT28 models · 1,284 reports · 2 recalls
• 3DMAX18 models · 1,067 reports
• VENTRIO18 models · 756 reports
• COMPOSIX18 models · 510 reports
• Hydro-Surg8 models · 307 reports · 2 recalls