Novafil SPB-1233GRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521100770), received between Jul 27, 2017 and Nov 29, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 16, 2026.

Recalls naming this device

1. Dec 2, 2022Open, 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.

• MalfunctionNov 29, 2023Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE OF THE DEVICE, WHEN TAKING THE PRODUCT OUT, THE SUTURE BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18234161 ↗
• MalfunctionNov 15, 2021Break; Break

  ACCORDING TO THE REPORTER, ON A DERMATOLOGY PROCEDURE, DURING SKIN CLOSURE, THE NEEDLE BROKE DURING SUTURING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. ANOTHER DEVICE FROM ANOTHER LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12816157 ↗
• MalfunctionOct 14, 2019Break; Break

  ACCORDING TO THE REPORTER, WHILE USING THE FIRST PACKET, THE THREAD OF THE SUTURE BROKE. THE EVENT OCCURRED DURING PROCEDURE BUT THE DEVICE WAS NOT USED ON THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9187590 ↗
• MalfunctionJul 27, 2017Break; Break

  ACCORDING TO THE REPORTER, WHEN THE USER STARTED SUTURING, THE THREAD BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6746798 ↗

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