McKesson SJ494GXRecalls & reported problems
Mckesson Medical-Surgical Inc. · SUTURE *4-0 POLYGLY ACID 18 DSM13 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10612479214580), received between Apr 28, 2023 and Aug 14, 2026 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component6
- Break1
Patient problems
- Insufficient Information4
- Unintended Radiation Exposure2
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2026Detachment of Device or Device Component
According to the reporter, during a sebaceous cyst extraction, after the package was opened, the provider attempted to place the first stitch. As the needle was passed through a small section of tissue and the suture was being pulled through, the needle detached from the suture and fell into the open wound, becoming retained in the soft tissues of the right scapular area. The wound was flushed and extensively probed and explored, and the patient was referred to the Emergency Department for ultrasound-guided removal of the needle and to a general surgeon for removal of the foreign body under fluoroscopy; however, removal was unsuccessful. An x-ray was performed, and the surgical time was extended by more than 30 minutes.
Patient problems: Foreign Body In Patient; Unintended Radiation Exposure
MAUDE report 50246460 ↗MalfunctionOct 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE BROKE OFF IN THE MIDDLE OF THE SURGERY. THIS ISSUE OCCURRED TWICE.
Patient problems: Insufficient Information
MAUDE report 20463612 ↗MalfunctionOct 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE BROKE OFF IN THE MIDDLE OF THE SURGERY. THIS ISSUE OCCURRED TWICE.
Patient problems: Insufficient Information
MAUDE report 20462943 ↗MalfunctionJul 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE POPPED OFF.
Patient problems: Insufficient Information
MAUDE report 17402695 ↗MalfunctionMay 23, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE NEEDLE BROKE TOO EASILY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16987179 ↗InjuryApr 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING SUTURING OF A SUPERFICIAL WOUND, THE NEEDLE BROKE OFF THE THREAD COMPLETELY. THE NEEDLE BECAME LOST IN PATIENT'S LEG. THE NEEDLE WAS RETRIEVED AFTER ULTRASOUND AND X-RAY.
Patient problems: Unintended Radiation Exposure
MAUDE report 16832097 ↗
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 · TerminatedSutures. 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
Other Suture, Absorbable, Synthetic, Polyglycolic Acid devices
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- V-Loc 180 VLOCL0316Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall376 reports
- Coated VICRYL VCP345HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death405 reports
- V-Loc 180 VLOCL0604Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall328 reports
- V-Loc 180 VLOCA008LCovidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall294 reports
- V-Loc 180 VLOCL0326Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID330 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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