ONFLEX 0115411Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741074431), received between Aug 6, 2018 and Jun 17, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, 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 ↗
• InjuryAug 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2018 THE PATIENT UNDERWENT THE REPAIR OF A LEFT INGUINAL HERNIA. THE SURGEON REPORTS THE PROCEDURE WAS ¿PERFECTLY ADEQUATE¿ AND ¿FELT THE MESH WAS PLACED WELL.¿ TEN DAYS POSTOPERATIVE A RECURRENCE WAS IDENTIFIED. TO DATE THERE HAS BEEN NO SURGICAL INTERVENTION.

  Patient problems: Hernia

  MAUDE report 7754417 ↗