SofsilkRecalls & reported problems across all models
Covidien LP · 120 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one Sofsilk model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 286
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls
- 3
We found 120 models of Sofsilk by Covidien LP in the FDA's device registry (GUDID). Together they are named in 286 adverse event reports in the FDA's MAUDE database, received between Feb 27, 2017 and Sep 29, 2026 — classified as 30 injuries, 256 malfunctions.
The most frequently reported specific device problem is “Break” (169 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 still open.
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
Sofsilk recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 25, 2024Open, Classified
One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence, hemorrhage, blood loss, bleeding, tissue breakdown, peritonitis, unspecified infection, vision loss (when used in ophthalmic application), and/or prolonged surgery.
Z-1697-2024 · Root cause: Process control · Recall details · FDA record ↗
- Dec 21, 2023Open, Classified
Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.
Z-0845-2024 · Root cause: Process control · names 40 of these models · Recall details · FDA record ↗
- Dec 2, 2022Open, Classified
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Z-1176-2023 · Root cause: Packaging process control · names 63 of these models · Recall details · FDA record ↗
Most reported Sofsilk problems
Device problems
- Break169
- Detachment of Device or Device Component92
- Manufacturing, Packaging or Shipping Problem37
- Detachment Of Device Component19
- Human-Device Interface Problem11
- Product Quality Problem6
- Adverse Event Without Identified Device or Use Problem4
- Component or Accessory Incompatibility3
Patient problems
- No Clinical Signs, Symptoms or Conditions152
- No Known Impact Or Consequence To Patient39
- No Consequences Or Impact To Patient34
- Insufficient Information24
- No Code Available12
- No Information12
- Radiation Exposure, Unintended11
- Foreign Body In Patient10
Sofsilk models
120 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Sofsilk S-2782KSUTURE, NONABSORBABLE, SILK3 recalls0 reports
- Sofsilk S-1768KSUTURE, NONABSORBABLE, SILK2 recalls5 reports
- Sofsilk S-304SUTURE, NONABSORBABLE, SILK2 recalls2 reports
- Sofsilk S-316SUTURE, NONABSORBABLE, SILK2 recalls2 reports
- Sofsilk S-187SUTURE, NONABSORBABLE, SILK2 recalls1 report
- Sofsilk S-605SUTURE, NONABSORBABLE, SILK2 recalls1 report
- Sofsilk CS-211SUTURE, NONABSORBABLE, SILK2 recalls0 reports
- Sofsilk S-1172SUTURE, NONABSORBABLE, SILK2 recalls0 reports
- Sofsilk S-1750KSUTURE, NONABSORBABLE, SILK2 recalls0 reports
- Sofsilk S-176SUTURE, NONABSORBABLE, SILK2 recalls0 reports
- Sofsilk S-182SUTURE, NONABSORBABLE, SILK2 recalls0 reports
- Sofsilk S-184SUTURE, NONABSORBABLE, SILK2 recalls0 reports
- Sofsilk S-185SUTURE, NONABSORBABLE, SILK2 recalls0 reports
- Sofsilk S-243SUTURE, NONABSORBABLE, SILK2 recalls0 reports
- Sofsilk S-245SUTURE, NONABSORBABLE, SILK2 recalls0 reports
- Sofsilk S-246SUTURE, NONABSORBABLE, SILK2 recalls0 reports
- Sofsilk S-303SUTURE, NONABSORBABLE, SILK2 recalls0 reports
- Sofsilk S-305SUTURE, NONABSORBABLE, SILK2 recalls0 reports
- Sofsilk S-317SUTURE, NONABSORBABLE, SILK2 recalls0 reports
- Sofsilk S-608SUTURE, NONABSORBABLE, SILK2 recalls0 reports
- Sofsilk SS-5641SUTURE, NONABSORBABLE, SILK2 recalls0 reports
- Sofsilk SS-645SUTURE, NONABSORBABLE, SILK2 recalls0 reports
- Sofsilk VS-872SUTURE, NONABSORBABLE, SILK2 recalls0 reports
- Sofsilk XX-5280SUTURE, NONABSORBABLE, SILK2 recalls0 reports
- Sofsilk VS872-2SUTURE, NONABSORBABLE, SILK2 recalls0 reports
- Sofsilk GSJ-33-MSUTURE, NONABSORBABLE, SILK54 reports
- Sofsilk SS-523SUTURE, NONABSORBABLE, SILK1 recall2 reports
- Sofsilk VS-871SUTURE, NONABSORBABLE, SILK1 recall2 reports
- Sofsilk GS-823SUTURE, NONABSORBABLE, SILK1 recall1 report
- Sofsilk GS-831SUTURE, NONABSORBABLE, SILK1 recall1 report
- Sofsilk GS-835SUTURE, NONABSORBABLE, SILK1 recall1 report
- Sofsilk S-244SUTURE, NONABSORBABLE, SILK1 recall1 report
- Sofsilk SS-5649GSUTURE, NONABSORBABLE, SILK1 recall1 report
- Sofsilk SS-623SUTURE, NONABSORBABLE, SILK1 recall1 report
- Sofsilk SS-681SUTURE, NONABSORBABLE, SILK1 recall1 report
- Sofsilk SS-689SUTURE, NONABSORBABLE, SILK1 recall1 report
- Sofsilk VS-806SUTURE, NONABSORBABLE, SILK1 recall1 report
- Sofsilk CS-490SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk CS-562SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk CS-792SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk S-1173SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk S-1174SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk S-1735SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk S-1789KSUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk S-183SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk S-206SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk S-2780KSUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk S-282SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk S-318SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk S-346SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk S-606SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk S-607SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk S-610SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk SS-525SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk SS-5641GSUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk SS-5678SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk SS-5684SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk SS-624SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk SS-653SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk SS-673SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk SS-675SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk SS-683GSUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk SS-685GSUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk SS-686SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk SS-745SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk SS-786SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk SS-787SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk VS-533SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk VS-845SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk VS-870SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk VS-882SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk XX-5278SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk XX-5281SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk XX-5284SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk SS-1694GSUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk VS890-2SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk VS581-2SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk VS871-2SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk GS453-2SUTURE, NONABSORBABLE, SILK1 recall0 reports
- Sofsilk GS-833SUTURE, NONABSORBABLE, SILK43 reports
- Sofsilk CS-10-MSUTURE, NONABSORBABLE, SILK26 reports
- Sofsilk 170004Endoscopic tissue approximation device13 reports
- Sofsilk GS-63-MSUTURE, NONABSORBABLE, SILK11 reports
- Sofsilk GS-834SUTURE, NONABSORBABLE, SILK10 reports
- Sofsilk GSJ-34-MSUTURE, NONABSORBABLE, SILK9 reports
- Sofsilk 170002Endoscopic tissue approximation device9 reports
- Sofsilk GS-832SUTURE, NONABSORBABLE, SILK8 reports
- Sofsilk GS-44-MSUTURE, NONABSORBABLE, SILK6 reports
- Sofsilk GS-46-MSUTURE, NONABSORBABLE, SILK6 reports
- Sofsilk GS-62-MSUTURE, NONABSORBABLE, SILK5 reports
- Sofsilk SS-678SUTURE, NONABSORBABLE, SILK5 reports
- Sofsilk GS-33-MSUTURE, NONABSORBABLE, SILK4 reports
- Sofsilk 170003Endoscopic tissue approximation device4 reports
- Sofsilk CS-424SUTURE, NONABSORBABLE, SILK3 reports
- Sofsilk GS-47-MSUTURE, NONABSORBABLE, SILK3 reports
- Sofsilk GS-67-MSUTURE, NONABSORBABLE, SILK3 reports
- Sofsilk GS-824SUTURE, NONABSORBABLE, SILK3 reports
- Sofsilk GSJ-63-MSUTURE, NONABSORBABLE, SILK3 reports
- Sofsilk SS-680SUTURE, NONABSORBABLE, SILK3 reports
- Sofsilk SS-695SUTURE, NONABSORBABLE, SILK3 reports
Recent Sofsilk adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938915 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938051 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933125 ↗MalfunctionAug 11, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50213844 ↗MalfunctionApr 16, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PACEMAKER IMPLANT PROCEDURE, WHEN THE NEEDLE WAS BEING REMOVED FROM THE RETAINER, PRIOR TO PATIENT INCISION, THE NEEDLE DETACHMENT FROM THE SUTURE WAS OBSERVED. THIS WAS REPORTED TO HAVE OCCURRED THREE TIMES. TO RESOLVE THE ISSUE, A NEW SUTURE FROM A DIFFERENT BRAND WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24905839 ↗MalfunctionApr 16, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PACEMAKER IMPLANT PROCEDURE, WHEN THE NEEDLE WAS BEING REMOVED FROM THE RETAINER, PRIOR TO PATIENT INCISION, THE NEEDLE DETACHMENT FROM THE SUTURE WAS OBSERVED. THIS WAS REPORTED TO HAVE OCCURRED THREE TIMES. TO RESOLVE THE ISSUE, A NEW SUTURE FROM A DIFFERENT BRAND WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24905762 ↗MalfunctionApr 16, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PACEMAKER IMPLANT PROCEDURE, WHEN THE NEEDLE WAS BEING REMOVED FROM THE RETAINER, PRIOR TO PATIENT INCISION, THE NEEDLE DETACHMENT FROM THE SUTURE WAS OBSERVED. THIS WAS REPORTED TO HAVE OCCURRED THREE TIMES. TO RESOLVE THE ISSUE, A NEW SUTURE FROM A DIFFERENT BRAND WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24901091 ↗MalfunctionFeb 17, 2026Break
IT WAS REPORTED THAT DURING AN OPEN SURGICAL PROCEDURE, TWO SUTURES BROKE WHILE SUTURING. THE SURGEON USED ANOTHER SUTURE FROM A DIFFERENT LOT TO RESOLVE THE ISSUE AND COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24371192 ↗MalfunctionFeb 17, 2026Break
IT WAS REPORTED THAT DURING AN OPEN SURGICAL PROCEDURE, TWO SUTURES BROKE WHILE SUTURING. THE SURGEON USED ANOTHER SUTURE FROM A DIFFERENT LOT TO RESOLVE THE ISSUE AND COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24371126 ↗MalfunctionFeb 11, 2026Break
ACCORDING TO THE REPORTER, IN A COLECTOMY, IT WAS NOTED THAT THE NEEDLE TIP WAS BROKEN WHEN THE SURGEON HANDED THE FORCEPS, STILL CLAMPING THE NEEDLE TIP, TO THE SCRUB NURSE AFTER SUTURING. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24311032 ↗MalfunctionDec 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LAPAROSCOPIC J TUBE PLACEMENT, THERE WAS NEEDLE DETACHMENT WHILE SUTURING AFTER PATIENT INCISION, WITH MINIMAL PRESSURE APPLIED. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23907439 ↗MalfunctionOct 28, 2025Break; Break
ACCORDING TO THE REPORTER DURING A PROCEDURE, TWO OF THE FIVE DETACHABLE NEEDLES HAD BROKEN TIPS. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 23401661 ↗MalfunctionOct 28, 2025Break; Break
ACCORDING TO THE REPORTER DURING A PROCEDURE, TWO OF THE FIVE DETACHABLE NEEDLES HAD BROKEN TIPS. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 23401583 ↗MalfunctionSep 15, 2025Break; Break
IT WAS REPORTED THAT DURING AN OPEN PACEMAKER IMPLANT PROCEDURE, THREE SUTURES BROKE IN THE MIDDLE UNDER LIGHT TENSION WHILE TYING DOWN LEADS. TO RESOLVE THE ISSUE, A SUTURE FROM ANOTHER MANUFACTURER WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23058125 ↗MalfunctionSep 15, 2025Break; Break
IT WAS REPORTED THAT DURING AN OPEN PACEMAKER IMPLANT PROCEDURE, THREE SUTURES BROKE IN THE MIDDLE UNDER LIGHT TENSION WHILE TYING DOWN LEADS. TO RESOLVE THE ISSUE, A SUTURE FROM ANOTHER MANUFACTURER WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23058098 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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