McKesson S635GXRecalls & reported problems
Mckesson Medical-Surgical Inc. · SUTURE *4-0 GUT CHR 18 DS18 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10612479214740), received between Apr 25, 2019 and Aug 8, 2024 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (7 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 Incompatibility7
- Break6
Patient problems
- Insufficient Information7
- No Information5
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 13 most recent of 13 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 EXTRACTIONS WITH ALVEOLAR PRESERVATION GRAFTING PROCEDURE, THE SUTURE DID NOT ABSORB FAST ENOUGH.
Patient problems: Insufficient Information
MAUDE report 19943966 ↗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 19942741 ↗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 19942294 ↗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 19942177 ↗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 19905967 ↗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 19905925 ↗MalfunctionJun 14, 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 19538280 ↗MalfunctionJul 12, 2019Break; Break
ACCORDING TO THE REPORTER, DURING SURGERY, THE SUTURE KEPT ON BREAKING DURING USE. IN ADDITION, ON THE PAST WEEK THEY HAD GONE THROUGH A BOX OF SUTURES THAT THEY COULD NOT USE.
Patient problems: No Information
MAUDE report 8784707 ↗MalfunctionApr 25, 2019Break; Break
ACCORDING TO THE REPORTER, THE SUTURE HAVE BEEN BREAKING.
Patient problems: No Information
MAUDE report 8553211 ↗MalfunctionApr 25, 2019Break; Break
ACCORDING TO THE REPORTER, DURING AN ORAL SURGERY, WHEN THE SECOND KNOT WAS TIED, THE THREAD BROKE. THEY OPENED ANOTHER SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8553210 ↗MalfunctionApr 25, 2019Break; Break
ACCORDING TO THE REPORTER, THE SUTURE HAVE BEEN BREAKING.
Patient problems: No Information
MAUDE report 8553208 ↗MalfunctionApr 25, 2019Break; Break
ACCORDING TO THE REPORTER, THE SUTURE HAVE BEEN BREAKING.
Patient problems: No Information
MAUDE report 8553205 ↗MalfunctionApr 25, 2019Break; Break
ACCORDING TO THE REPORTER, THE SUTURE HAVE BEEN BREAKING.
Patient problems: No Information
MAUDE report 8553203 ↗
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-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)
- 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
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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