McKesson SJ493GXRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10612479214566), received between Jun 29, 2022 and Feb 2, 2026 — classified as 2 injuries, 4 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K963253); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, PATIENT DEVELOPED LESIONS OVER HEALING SITES.

  Patient problems: Localized Skin Lesion

  MAUDE report 24242893 ↗
• InjuryNov 18, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING SKIN BIOPSY IN A CLINICAL STUDY, THE NEEDLE BROKE CAUSING SEVERE PAIN. THE NEEDLE HAD TO BE EXCISED FROM THE BIOPSY SITE WITH A SCALPEL. IT WAS MENTIONED THAT THE ADMINISTERED ANESTHETIC DURING THE PROCEDURE WAS INSUFFICIENT DUE TO CONFLICT WITH OTHER MEDICATIONS. AFTER THE PROCEDURE, THE PATIENT CONTINUED TO EXPERIENCE SEVERE UNCONTROLLED PAIN. THE PATIENT HAD LOSS OF ABILITY TO WORK, IMPACTED ACTIVITIES OF DAILY LIVING, AND EMOTIONAL CHANGES. THE PATIENT REQUESTED A THIRD-PARTY IMAGING CENTER FOR AN X-RAY TO CONFIRM THAT THERE WAS NO METAL LEFT FROM THE NEEDLE BREAKAGE. THE PATIENT IS CURRENTLY STILL EXPERIENCING PHYSICAL PAIN AND TENDERNESS AT THE WOUND SITE AND IS ON BOTH TOPICAL AND ORAL ANTIBIOTICS.

  Patient problems: Emotional Changes; Pain; Unintended Radiation Exposure; Unspecified Tissue Injury

  MAUDE report 23583533 ↗
• MalfunctionJul 10, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE BROKE OFF MID SURGERY. IT WAS NOTED THAT THE BROKEN TIP OF THE NEEDLE WAS RECOVERED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22475280 ↗
• InjuryNov 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN NASAL FLAP CLOSURE, THE NEEDLE BROKE AND LODGED INTO THE PATIENT'S NOSE. THE PHYSICIAN LOOKED FOR 10-15 MINUTES AND COULD FIND NOTHING LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15738284 ↗
• MalfunctionAug 10, 2022Product Quality Problem; Use of Device Problem; Product Quality Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE ISSUE IS WITH THE SUTURE, THE SWAGED END WHERE THE SUTURE MEETS THE NEEDLE HAD A BULBOUS THICKENING THAT WOULD NOT ALLOW THE NEEDLE TO PASS THROUGH THE SKIN WITHOUT APPLYING A LOT OF FORCE TO PULL IT THROUGH.

  Patient problems: Insufficient Information

  MAUDE report 15202405 ↗
• MalfunctionJun 29, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN PROCEDURE OF WOUND CLOSURE, WHILE SUTURING, THE THREAD BROKE. TO RESOLVE THE ISSUE, ANOTHER SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14861874 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963253. One submission often covers many models, so check the product and lot details in each record.

• Z-2541-2017 · May 3, 2017 · Terminated
  Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VI