BiosynRecalls & reported problems across all models
Covidien LP · 94 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,527
- Deaths reported
- 0
- Injuries reported
- 131
- Recalls
- 0
We found 94 models of Biosyn by Covidien LP in the FDA's device registry (GUDID). Together they are named in 1,527 adverse event reports in the FDA's MAUDE database, received between Sep 26, 2016 and Sep 23, 2026 — classified as 131 injuries, 1,396 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (707 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Biosyn problems
Device problems
- Detachment of Device or Device Component707
- Break628
- Adverse Event Without Identified Device or Use Problem93
- Unraveled Material86
- Patient-Device Incompatibility75
- Mechanical Problem37
- Material Twisted/Bent16
- Insufficient Device Problem Information10
Patient problems
- No Clinical Signs, Symptoms or Conditions726
- No Consequences Or Impact To Patient187
- Insufficient Information186
- No Known Impact Or Consequence To Patient163
- Wound Dehiscence81
- No Code Available71
- Unspecified Tissue Injury37
- No Patient Involvement35
Biosyn models
94 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Biosyn SM-5637SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID147 reports
- Biosyn GM-122SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID113 reports
- Biosyn SM-5638SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID113 reports
- Biosyn SM-5627SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID101 reports
- Biosyn SM-5679GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID78 reports
- Biosyn SM-691SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID64 reports
- Biosyn SM-822SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID54 reports
- Biosyn GM-875SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID49 reports
- Biosyn SM-5687SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID48 reports
- Biosyn GM-324SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID46 reports
- Biosyn SM-693SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID43 reports
- Biosyn SM-5628SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID40 reports
- Biosyn GM-123SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID34 reports
- Biosyn GM-181SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID34 reports
- Biosyn CM-925SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID32 reports
- Biosyn UM-203SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID31 reports
- Biosyn SM-5690SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID30 reports
- Biosyn CM-879SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID29 reports
- Biosyn SM-922SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID24 reports
- Biosyn UM-204SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID22 reports
- Biosyn SM-923SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID19 reports
- Biosyn SM-823SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID18 reports
- Biosyn GM-327SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID16 reports
- Biosyn UM-878SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID15 reports
- Biosyn XX-5229JSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID15 reports
- Biosyn CM-811SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID14 reports
- Biosyn SM-5678SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID13 reports
- Biosyn SM-632SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID13 reports
- Biosyn CM-817SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID12 reports
- Biosyn GM-322SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID12 reports
- Biosyn CM-790LSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID12 reports
- Biosyn UM-986SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID12 reports
- Biosyn SM-643SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID11 reports
- Biosyn GM-183SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID10 reports
- Biosyn UM-877SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID10 reports
- Biosyn CM-812SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID9 reports
- Biosyn GMJ-33-MSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID9 reports
- Biosyn CM-543SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID8 reports
- Biosyn CM-816SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID8 reports
- Biosyn SM-644SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID8 reports
- Biosyn UM-202SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID8 reports
- Biosyn CM-953SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID7 reports
- Biosyn CM-954SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID7 reports
- Biosyn CMT-949-MSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID7 reports
- Biosyn CM-813SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID6 reports
- Biosyn CM-904SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID6 reports
- Biosyn CM-884SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID5 reports
- Biosyn CM-966SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID5 reports
- Biosyn GM-121SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID5 reports
- Biosyn UM-213SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID5 reports
- Biosyn UM-214SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID5 reports
- Biosyn CM-905SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID4 reports
- Biosyn GM-291SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID4 reports
- Biosyn M-74SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID4 reports
- Biosyn SM-791SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID4 reports
- Biosyn CM-883SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Biosyn CM-914SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Biosyn CM-923SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Biosyn CMT-974SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Biosyn GMJ-34-MSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Biosyn M-32SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Biosyn SM-3626SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Biosyn SM-5679SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Biosyn SM-691GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Biosyn UM-215SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Biosyn CM-832SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Biosyn CM-31-MSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Biosyn CM-882SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Biosyn CMT-740-MSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Biosyn GM-222SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Biosyn GM-281SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Biosyn GM-321SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Biosyn SM-5624SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Biosyn CM-776LSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Biosyn CM-30-MSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Biosyn GMJ-63-MSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Biosyn CM-830SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Biosyn CM-843SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Biosyn CM-845SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Biosyn CM-924SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Biosyn CMT-811SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Biosyn GM-125SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Biosyn GM-227SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Biosyn GM-323SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Biosyn GM-332SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Biosyn M-72SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Biosyn SM-5688SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Biosyn UM-403SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Biosyn UM-886SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Biosyn CM-765-LSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Biosyn CMT-789-LSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Biosyn XM-845SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Biosyn CM-767LSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Biosyn CM-827SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
Recent Biosyn adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Detachment of Device or Device Component
According to the reporter, pre-operatively, three new sutures were opened but the needles also detached from the thread with a gentle tug while being removed from the retainer. Another suture had its needle detach from the thread at the time of suturing. Another suture was used but had the same issue.
Patient problems: Insufficient Information
MAUDE report 50863649 ↗MalfunctionSep 23, 2026Detachment of Device or Device Component
According to the reporter, pre-operatively, three new sutures were opened but the needles also detached from the thread with a gentle tug while being removed from the retainer. Another suture had its needle detach from the thread at the time of suturing. Another suture was used but had the same issue.
Patient problems: Insufficient Information
MAUDE report 50863645 ↗MalfunctionSep 23, 2026Detachment of Device or Device Component
According to the reporter, pre-operatively, three new sutures were opened but the needles also detached from the thread with a gentle tug while being removed from the retainer. Another suture had its needle detach from the thread at the time of suturing. Another suture was used but had the same issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863627 ↗MalfunctionSep 23, 2026Detachment of Device or Device Component
According to the reporter, pre-operatively, three new sutures were opened but the needles also detached from the thread with a gentle tug while being removed from the retainer. Another suture had its needle detach from the thread at the time of suturing. Another suture was used but had the same issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863626 ↗MalfunctionSep 23, 2026Detachment of Device or Device Component
According to the reporter, pre-operatively, three new sutures were opened but the needles also detached from the thread with a gentle tug while being removed from the retainer. Another suture had its needle detach from the thread at the time of suturing. Another suture was used but had the same issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863625 ↗MalfunctionSep 23, 2026Detachment of Device or Device Component
According to the reporter, pre-operatively, three new sutures were opened but the needles also detached from the thread with a gentle tug while being removed from the retainer. Another suture had its needle detach from the thread at the time of suturing. Another suture was used but had the same issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863623 ↗MalfunctionSep 22, 2026Detachment of Device or Device Component
According to the reporter, during a procedure, the needle and thread were detached. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859097 ↗MalfunctionSep 22, 2026Detachment of Device or Device Component
According to the during the procedure, the suture needle detached from the suture material while in use. To complete the procedure, new packs of suture were opened and used as a replacement. The case was completed successfully. No patient injury was reported.
Patient problems: Insufficient Information
MAUDE report 50853862 ↗MalfunctionSep 21, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information
MAUDE report 50846530 ↗MalfunctionSep 21, 2026Detachment of Device or Device Component
According to the reporter, during a procedure, while removing the suture from the retainer, the needle detached. A new suture was used to resolve the issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50836918 ↗MalfunctionSep 19, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information
MAUDE report 50831750 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information
MAUDE report 50831584 ↗MalfunctionAug 19, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50322114 ↗MalfunctionAug 19, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50322111 ↗MalfunctionAug 14, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50254991 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page