Monosof SN-653Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521079533), received between Jun 28, 2019 and Dec 11, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K900531); 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.

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.

• MalfunctionDec 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SKIN CLOSURE, THE SUTURE BROKE AT THE CONNECTION OF THE NEEDLE AND THREAD WHILE SUTURING. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783094 ↗
• MalfunctionAug 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A REMOVAL OF LIPOMA, THE NEEDLE DETACHED. A NEW SUTURE FROM THE SAME BATCH WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20007912 ↗
• MalfunctionJun 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SKIN SUTURING PROCEDURE, AFTER OPENING THE PACKAGE, THE NEEDLE DETACH FROM THE STRAND, EVEN BEFORE TOUCHING IT. ANOTHER SUTURE DEVICE WAS TAKEN TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746452 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K900531. One submission often covers many models, so check the product and lot details in each record.

• Z-1173-2023 · Dec 2, 2022 · Open, Classified
  Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 SILK 18 DS18 (3) S683GX
• Z-1174-2023 · Dec 2, 2022 · Open, Classified
  Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-12 MONOSOF* 2-0 BLK 10