SurgilonRecalls & reported problems across all models
Covidien LP · 29 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Surgilon model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 80
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 2
We found 29 models of Surgilon by Covidien LP in the FDA's device registry (GUDID). Together they are named in 80 adverse event reports in the FDA's MAUDE database, received between May 11, 2017 and Jul 21, 2026 — classified as 6 injuries, 74 malfunctions.
The most frequently reported specific device problem is “Break” (42 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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
Surgilon 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.
- 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-0844-2024 · Root cause: Process control · names 4 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-1178-2023 · Root cause: Packaging process control · names 12 of these models · Recall details · FDA record ↗
Most reported Surgilon problems
Device problems
- Break42
- Manufacturing, Packaging or Shipping Problem29
- Detachment of Device or Device Component11
- Component Missing2
- Detachment Of Device Component2
- Material Frayed1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- No Known Impact Or Consequence To Patient24
- No Consequences Or Impact To Patient7
- No Code Available6
- No Patient Involvement4
- Radiation Exposure, Unintended4
- Insufficient Information3
- Foreign Body In Patient2
Surgilon models
29 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Surgilon 88861919-41SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 recalls2 reports
- Surgilon 88861919-31SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 recalls0 reports
- Surgilon 88861919-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 recalls0 reports
- Surgilon 88861919-71SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 recalls0 reports
- Surgilon 88861883-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Surgilon 88861915-71SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Surgilon 88861919-61SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Surgilon 88861932-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Surgilon 88861971-71SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Surgilon 88861985-71SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Surgilon SBS-1884GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Surgilon SBS-1928GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Surgilon 88861953-32JSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE27 reports
- Surgilon 88861957-32SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE15 reports
- Surgilon 88861917-71SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE6 reports
- Surgilon 88861954-32JSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE6 reports
- Surgilon 88861927-32SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE5 reports
- Surgilon 88861990-42JSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE4 reports
- Surgilon 88861918-31SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE3 reports
- Surgilon 88861995-41SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE3 reports
- Surgilon 88861917-61SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Surgilon 88861918-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Surgilon 88861931-43SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Surgilon 88861935-41SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Surgilon 88861962-62SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Surgilon 88861962-72SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Surgilon 88861971-61SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Surgilon 88861993-62SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Surgilon 88861995-31SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
Recent Surgilon adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25885095 ↗MalfunctionMar 30, 2026Break
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, BEFORE OPENING THE PACKAGE AND REMOVING THE SUTURE, THE THREAD WAS BROKEN AT CENTER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24711815 ↗MalfunctionNov 6, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A DURAL CLOSURE, DURING SUTURING, THE NEEDLE WAS BROKEN ON THE CENTRAL PART, BUT IT DID NOT FALL INTO THE PATIENT'S CAVITY. THE SAME ISSUE OCCURRED ON THE SECOND AND THIRD NEEDLES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23486485 ↗MalfunctionNov 6, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A DURAL CLOSURE, DURING SUTURING, THE NEEDLE WAS BROKEN ON THE CENTRAL PART, BUT IT DID NOT FALL INTO THE PATIENT'S CAVITY. THE SAME ISSUE OCCURRED ON THE SECOND AND THIRD NEEDLES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23486425 ↗MalfunctionNov 6, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A DURAL CLOSURE, DURING SUTURING, THE NEEDLE WAS BROKEN ON THE CENTRAL PART, BUT IT DID NOT FALL INTO THE PATIENT'S CAVITY. THE SAME ISSUE OCCURRED ON THE SECOND AND THIRD NEEDLES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23485811 ↗MalfunctionOct 17, 2025Break; Break
IT WAS REPORTED THAT WHEN USING THE SUTURE, IT WAS VERY HARD TO PICK UP WITH FORCEPS BECAUSE IT BROKE APART, AND WHEN CUTTING THE SUTURE, IT TORE AT THE CUT SITE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23320417 ↗MalfunctionOct 17, 2025Break; Break
IT WAS REPORTED THAT WHEN USING THE SUTURE, IT WAS VERY HARD TO PICK UP WITH FORCEPS BECAUSE IT BROKE APART, AND WHEN CUTTING THE SUTURE, IT TORE AT THE CUT SITE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23320408 ↗MalfunctionApr 21, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
ACCORDING TO THE REPORTER, PRIOR A BRAIN TUMOR RESECTION, IT WAS NOTED THAT THE NEEDLE QUANTITY IN THE PACKAGE WAS INCORRECT; THERE WERE FEWER NEEDLES IN THE PACKAGE. ANOTHER PACK WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21873255 ↗MalfunctionJan 17, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A CRANIOTOMY PROCEDURE, WHILE SUTURING IN THE EXTRACEREBRAL DURAL CLOSURE, THE NEEDLE TIP BROKE. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21179152 ↗MalfunctionNov 15, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN FIXATING THE SUTURE, THE PACKAGE HAD (B)(4) UNITS, WHICH NORMALLY HAD (B)(4) UNITS. IT WAS NOTED THAT IT WAS DISCONTINUED TO USE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20695534 ↗MalfunctionApr 24, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
ACCORDING TO THE REPORTER, DURING CRANIOTOMY, WHEN SUTURING THE DURA MATER AND USING THE NODULE AND LIGATION SUTURE TECHNIQUE, THE SURGEON NOTED THAT THE PACKAGE SHOULD HAVE HAD FIVE SUTURES, BUT IT CONTAINED SIX SUTURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19173731 ↗MalfunctionApr 24, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
ACCORDING TO THE REPORTER, DURING CRANIOTOMY, WHEN SUTURING THE DURA MATER AND USING THE NODULE AND LIGATION SUTURE TECHNIQUE, THE SURGEON NOTED THAT THE PACKAGE SHOULD HAVE HAD FIVE SUTURES, BUT IT CONTAINED SIX SUTURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19173550 ↗MalfunctionFeb 7, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE SUTURE COUNT WAS WRONG; IT HAD 6 INSTEAD OF 5. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18664592 ↗MalfunctionDec 12, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THERE WERE 6 SUTURES INSTEAD OF JUST 5 IN THE PACK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18315254 ↗MalfunctionNov 16, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
ACCORDING TO THE REPORTER, DURING A BRAIN LAPAROTOMY, WHEN OPENING THE PACKAGE, THERE WERE SIX SUTURES FOUND INSTEAD OF JUST FIVE. THERE WERE NO PARTICULAR PROBLEMS WITH THE THREAD OR NEEDLE, SO SUTURES WERE STILL USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18154270 ↗
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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