McKesson S8699GXRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10612479214726), received between Jun 3, 2020 and Jan 16, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 reports).

2 other recalls cover devices cleared under the same FDA submission (K050947); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLES KEPT FALLING OFF THE SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 24103374 ↗
• MalfunctionJan 16, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE SKIN EXCISION, THE SUTURE DISCONNECTED FROM THE NEEDLE ON TWO OCCASIONS. THE SURGEON OBTAINED ADDITIONAL SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24103337 ↗
• InjuryNov 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A PROCEDURE, THE SUTURE BROKE OFF AT THE NEEDLE END AND THE NEEDLE FELL INTO AN OPEN WOUND OF THE PATIENT AND WAS UNABLE TO BE RETRIEVED UNTIL THE FOLLOWING DAY VIA GUIDANCE OF ELECTROMAGNETIC IMAGING.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 18232026 ↗
• MalfunctionApr 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHILE SUTURING, THE NEEDLE DETACHED FROM THE THREAD. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141727 ↗
• MalfunctionMar 19, 2022Break; Break

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC PROCEDURE, AT THE TIME OF CLOSING, THE THREAD BROKE. AN ADDITIONAL SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13827545 ↗
• InjuryJul 16, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE NEEDLE BROKE OFF UNDER A PATIENT'S SKIN. THE SURGEON HAD TO REOPEN THE WOUND AND REMOVE IT THEN GET ANOTHER SUTURE AND START AGAIN. THE INCISION EXTENDED DUE TO THE PRODUCT PROBLEM.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12183472 ↗
• MalfunctionJun 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN TYING OFF THE SUTURE DURING A SKIN BIOPSY, THE SUTURE SEPARATED FROM THE ACTUAL NEEDLE. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10116399 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050947. One submission often covers many models, so check the product and lot details in each record.

• Z-2922-2026 · Jun 24, 2026 · Open, Classified
  Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
• Z-1180-2023 · Dec 2, 2022 · Open, Classified
  Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X SURGIPRO II 4-0 90CM KV5 DA7P VP435X VP-541X S