DermalonRecalls & reported problems across all models
Covidien LP · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Dermalon model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 58
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 20 models of Dermalon by Covidien LP in the FDA's device registry (GUDID). Together they are named in 58 adverse event reports in the FDA's MAUDE database, received between Jul 14, 2017 and Jun 8, 2026 — classified as 58 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (32 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
Dermalon 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.
- Jun 24, 2026Open, Classified
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Z-2920-2026 · Root cause: Equipment maintenance · names 2 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-1172-2023 · Root cause: Packaging process control · names 4 of these models · Recall details · FDA record ↗
Most reported Dermalon problems
Device problems
- Detachment of Device or Device Component32
- Break26
- Component Missing1
- Device Slipped1
- Insufficient Device Problem Information1
- Material Separation1
- Material Twisted/Bent1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- Insufficient Information13
- No Known Impact Or Consequence To Patient8
- No Consequences Or Impact To Patient5
- No Information1
- No Patient Involvement1
Dermalon models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Dermalon 88861749-24SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall4 reports
- Dermalon 88861741-11SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall2 reports
- Dermalon 88861757-31SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall1 report
- Dermalon 88861799-31SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall1 report
- Dermalon 88861747-11SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Dermalon 88861757-41SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Dermalon 88861741-31SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE14 reports
- Dermalon 88861756-41SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE6 reports
- Dermalon 88861741-21SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE5 reports
- Dermalon 88861744-41SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE5 reports
- Dermalon 88861744-31SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE4 reports
- Dermalon 88861742-21SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE3 reports
- Dermalon 88861756-31SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE3 reports
- Dermalon 88861742-41SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 reports
- Dermalon 88861754-13SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 reports
- Dermalon 88861799-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 reports
- Dermalon 88861727-41SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Dermalon 88861742-31SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Dermalon 88861756-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Dermalon 88861799-41SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
Recent Dermalon adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, THE CONNECTION OF THE NEEDLE AND THREAD BROKE WHILE SUTURING. 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 25436438 ↗MalfunctionJan 23, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, ON TWO DEVICES, THE NEEDLE DETACHED AS A WHOLE. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24164652 ↗MalfunctionSep 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT PREOPERATIVELY, THE NEEDLE DETACHED FROM THE SUTURE WHILE REMOVING IT FROM THE RETAINER. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23088044 ↗MalfunctionMar 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING SUTURING, THE FOUR NEEDLE DETACHMENT OCCURRED WHILE PREPARING THE SUTURE AFTER PATIENT INCISION. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21567250 ↗MalfunctionMar 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING SUTURING, A FOUR NEEDLE DETACHMENT OCCURRED WHILE PREPARING THE SUTURE AFTER PATIENT INCISION. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21567249 ↗MalfunctionMar 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING SUTURING, A FOUR NEEDLE DETACHMENT OCCURRED WHILE PREPARING THE SUTURE AFTER PATIENT INCISION. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21567232 ↗MalfunctionMar 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING SUTURING, A FOUR NEEDLE DETACHMENT OCCURRED WHILE PREPARING THE SUTURE AFTER PATIENT INCISION. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21567215 ↗MalfunctionMar 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING SKIN CLOSURE IN FOOT/ANKLE PROCEDURES, WITH THE SUTURE, THE NEEDLE DETACHMENT OCCURRED WHILE PREPARING THE SUTURE AFTER THE PATIENT INCISION. AN ADDITIONAL NEW SUTURE WAS USED FROM OTHER COMPANY WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21567035 ↗MalfunctionMar 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SKIN CLOSURE IN FOOT/ANKLE PROCEDURES, NEEDLE DETACHMENT OCCURRED WHILE PREPARING THE SUTURE AFTER PATIENT INCISION. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21562385 ↗MalfunctionNov 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A SKIN CLOSURE, WHILE SUTURING, THERE WAS A NEEDLE DETACHMENT. IT WAS NOTED THAT NO COMPONENT FELL IN THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20773121 ↗MalfunctionNov 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER DURING A SKIN CLOSURE PROCEDURE, WHILE SUTURING A FEW STITCHED, THE SURGEON PUT DOWN THE SUTURE FOR A WHILE. AND WHEN THE SUTURE WAS HELD AGAIN, THE NEEDLE AND SUTURED SEPARATED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20612786 ↗MalfunctionMar 22, 2024Break; Break
ACCORDING TO THE REPORTER, PREOPERATIVELY. WHEN THE SUTURE WAS MANIPULATED AND STRETCHED IT, THE SUTURE BROKE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18962014 ↗MalfunctionMar 21, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A FUNDOPLICATION PROCEDURE, WHEN THE SUTURE WAS HANDLED IT BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18956375 ↗MalfunctionMar 4, 2024Device Slipped; Unraveled Material; Device Slipped; Unraveled Material
ACCORDING TO THE REPORTER, 2-3 DAYS POSTOPERATIVELY OF A DENTAL EXTRACTION, THE SUTURE WAS USED IN THE GUM AFTER TOOTH EXTRACTION VIA A THREE-TIMES KNOTTED SUTURING TECHNIQUE. HOWEVER, THE PATIENT FOUND THE KNOT HAD SLIPPED AND THE SUTURE LINE HAD UNRAVELED AFTER APPLICATION. IT WAS NOTED THAT THE GUM CLOSED BY ITSELF. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18832223 ↗MalfunctionJan 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE SUTURE THREAD CAME AWAY FROM THE NEEDLE WHEN LOADED. ANOTHER TWO SUTURES WERE USED, AND ALL SUTURES CAME AWAY FROM THE NEEDLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18567830 ↗
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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