Surgipro SP-683GRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521037472), received between Aug 20, 2019 and Jun 22, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K954808); 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.

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.

• MalfunctionJun 22, 2026Break; Device Slipped

  ACCORDING TO THE REPORTER, IN A SURGICAL EXCISION, WHEN THE SURGEON WENT TO GENTLY WIPE THE AREA WITH ALCOHOL, THE KNOT UNRAVELED AND THE SUTURE BROKE APART IN THE MIDDLE OF THE SITE. ANOTHER SUTURE FROM A DIFFERENT BOX WAS USED BUT THE SAME ISSUE OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 25577599 ↗
• MalfunctionApr 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THREE SUTURES HAD NEEDLES POPPING OFF THE THREADS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14214592 ↗
• MalfunctionNov 2, 2020Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, UPON REMOVING THE DEVICE FROM THE PACKAGE, ONE OF THE THREAD OF THE SUTURES WAS FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 10774843 ↗
• MalfunctionAug 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, WHEN THE PACKAGE WAS OPENED, THE DEVICE'S THREAD WAS DETACHED FROM THE NEEDLE. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8913752 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K954808. One submission often covers many models, so check the product and lot details in each record.

• Z-1179-2023 · Dec 2, 2022 · Open, Classified
  Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP