Novafil 8886 4410-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521099692), received between Aug 28, 2020 and Feb 12, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K990952); they may or may not involve this specific model.

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.

Recalls naming this device

1. Dec 2, 2022Class IIOpen, Classified

   Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

   Z-1175-2023 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Break

  IT WAS REPORTED THAT DURING A SKIN TRANSDERMAL CLOSURE, THE SUTURE BROKE WHILE SUTURING, SPECIFICALLY IN THE MIDDLE OF THE STRAND. THE STRAND BROKE WITH ALMOST NO TENSION APPLIED. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE FROM THE SAME BATCH. A NEW SUTURE FROM COMPETITOR WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321740 ↗
• MalfunctionFeb 12, 2026Break

  IT WAS REPORTED THAT DURING A SKIN TRANSDERMAL CLOSURE, THE SUTURE BROKE WHILE SUTURING, SPECIFICALLY IN THE MIDDLE OF THE STRAND. THE STRAND BROKE WITH ALMOST NO TENSION APPLIED. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE FROM THE SAME BATCH. A NEW SUTURE FROM COMPETITOR WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321729 ↗
• MalfunctionDec 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SURGERY, THE NEEDLE DETACHED FROM THE STRAND AT THE SWAGE WHILE BEING REMOVED FROM THE RETAINER AND PREPARED PRIOR TO PATIENT INCISION. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23835938 ↗
• MalfunctionAug 28, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPHTHALMOLOGICAL PROCEDURE, WHEN THE PACKAGE OF THE PRODUCT WAS OPENED FOR SUBCUTANEOUS SUTURE, THE THREAD WAS FOUND TO BE BROKEN. THE DEVICE WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER INSTRUMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10465581 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K990952. One submission often covers many models, so check the product and lot details in each record.

• Z-1181-2023 · Dec 2, 2022 · Open, Classified
  Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA 88863012-61 TICRON* 0 BLU 90CM C16 X36 8