McKesson S636GXRecalls & reported problems
Mckesson Medical-Surgical Inc. · SUTURE *3-0 GUT CHR 30 DS18 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10612479214764), received between Aug 5, 2024 and Aug 8, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 reports).
3 other recalls cover devices cleared under the same FDA submission (K142656); 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.
Reports received per month
Most reported problems
Device problems
- Patient-Device Incompatibility3
Patient problems
- Insufficient Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO THE REPORTER, AFTER AN OPEN PROCEDURE, THE SUTURE DID NOT ABSORB FAST ENOUGH.
Patient problems: Insufficient Information
MAUDE report 19943087 ↗MalfunctionAug 8, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO THE REPORTER, AFTER AN EXTRACTIONS WITH ALVEOLAR PRESERVATION GRAFTING PROCEDURE, THE SUTURE DID NOT ABSORB FAST ENOUGH.
Patient problems: Insufficient Information
MAUDE report 19942732 ↗MalfunctionAug 5, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO THE REPORTER, AFTER A WISDOM TEETH EXTRACTION PROCEDURE, THE SUTURE DID NOT ABSORB FAST ENOUGH.
Patient problems: Insufficient Information
MAUDE report 19906034 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K142656. One submission often covers many models, so check the product and lot details in each record.
- Z-1388-2023 · Mar 1, 2023 · Open, ClassifiedChromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC GUT 3-0 75CM V20 X36 (G
- Z-1390-2023 · Mar 1, 2023 · Open, ClassifiedPlain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC-11 DA (SG828-2)
- Z-1389-2023 · Mar 1, 2023 · Open, ClassifiedMild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)
Other Suture, Absorbable, Natural devices
- Chromic Gut GG-122Covidien LP · SUTURE, ABSORBABLE, NATURAL1 recall12 reports
- Chromic Gut G-1780KCovidien LP · SUTURE, ABSORBABLE, NATURAL1 recall8 reports
- Chromic Gut UG-202Covidien LP · SUTURE, ABSORBABLE, NATURAL1 recall7 reports
- Chromic Gut UG-203Covidien LP · SUTURE, ABSORBABLE, NATURAL1 recall6 reports
- Plain Gut SG-5686Covidien LP · SUTURE, ABSORBABLE, NATURAL1 recall6 reports
- Chromic Gut SG-5687GCovidien LP · SUTURE, ABSORBABLE, NATURAL1 recall6 reports
- Chromic Gut GG-123Covidien LP · SUTURE, ABSORBABLE, NATURAL1 recall6 reports
- Chromic Gut GG-121Covidien LP · SUTURE, ABSORBABLE, NATURAL1 recall3 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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