NovafilRecalls & reported problems across all models
Covidien LP · 39 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Novafil model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 127
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 1
We found 39 models of Novafil by Covidien LP in the FDA's device registry (GUDID). Together they are named in 127 adverse event reports in the FDA's MAUDE database, received between Jul 27, 2017 and Mar 25, 2026 — classified as 3 injuries, 124 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (75 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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
Novafil 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 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-1175-2023 · Root cause: Packaging process control · names 23 of these models · Recall details · FDA record ↗
Most reported Novafil problems
Device problems
- Detachment of Device or Device Component75
- Break57
- Adverse Event Without Identified Device or Use Problem3
- Detachment Of Device Component3
- Material Twisted/Bent2
- Failure to Fire1
- Mechanics Altered1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions82
- Insufficient Information23
- No Consequences Or Impact To Patient14
- No Known Impact Or Consequence To Patient10
- No Information3
- No Patient Involvement2
- Abscess1
- Foreign Body In Patient1
Novafil models
39 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Novafil 8886 4410-03SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall68 reports
- Novafil 8886 4401-23SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall12 reports
- Novafil 8886 4410-13SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall4 reports
- Novafil 8886 4452-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall4 reports
- Novafil SPB-1233GSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall4 reports
- Novafil SPB-1213GSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall2 reports
- Novafil SPB-5223GSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall2 reports
- Novafil 8886 4402-33SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall1 report
- Novafil SPB-5143GSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall1 report
- Novafil 8886 4002-41SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Novafil 8886 4403-33SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Novafil 8886 4422-43SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Novafil 8886 4424-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Novafil 8886 4450-41SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Novafil 8886 4459-61SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Novafil 88864470-81SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Novafil 88864582-53SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Novafil SPB-1623GSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Novafil SPB-5142GSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Novafil SPB-5433GSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Novafil SPB-5633GSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Novafil 8886 4400-13SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Novafil 8886 4400-23SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Novafil 8886 4419-23SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE5 reports
- Novafil 8886 4420-33SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE5 reports
- Novafil 8886 4419-33SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE3 reports
- Novafil 8886 4424-41SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- Novafil 88864582-43SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- Novafil CPB-738GSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- Novafil 8886 4027-21SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Novafil 8886 4028-31SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Novafil 8886 4415-43SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Novafil 8886 4419-13SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Novafil 8886 4420-23SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Novafil 8886 4420-43SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Novafil 8886 4425-31SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Novafil SPB-5833GSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Novafil SPB-5843GSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Novafil 8886 4452-61SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
Recent Novafil adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2026Break
IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE. AN ADDITIONAL NEW SUTURE WAS USED BUT ALSO BROKE. ANOTHER SAME SUTURE 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 24691422 ↗MalfunctionMar 25, 2026Break
IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE. AN ADDITIONAL NEW SUTURE WAS USED BUT ALSO BROKE. ANOTHER SAME SUTURE 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 24691334 ↗MalfunctionFeb 12, 2026Break
IT WAS REPORTED THAT DURING A SKIN TRANSDERMAL CLOSURE, THE SUTURE BROKE WHILE SUTURING, SPECIFICALLY IN THE MIDDLE OF THE STRAND. THE STRAND BROKE WITH ALMOST NO TENSION APPLIED. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE FROM THE SAME BATCH. A NEW SUTURE FROM COMPETITOR 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 24321740 ↗MalfunctionFeb 12, 2026Break
IT WAS REPORTED THAT DURING A SKIN TRANSDERMAL CLOSURE, THE SUTURE BROKE WHILE SUTURING, SPECIFICALLY IN THE MIDDLE OF THE STRAND. THE STRAND BROKE WITH ALMOST NO TENSION APPLIED. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE FROM THE SAME BATCH. A NEW SUTURE FROM COMPETITOR 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 24321729 ↗MalfunctionDec 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A COSMETIC SURGERY, TWO SUTURES DETACHED FROM THE NEEDLE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23892584 ↗MalfunctionDec 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A COSMETIC SURGERY, TWO SUTURES DETACHED FROM THE NEEDLE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23892576 ↗MalfunctionDec 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING SURGERY, THE NEEDLE DETACHED FROM THE STRAND AT THE SWAGE WHILE BEING REMOVED FROM THE RETAINER AND PREPARED PRIOR TO PATIENT INCISION. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23835938 ↗MalfunctionNov 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN INCISION PROCEDURE, DURING SUTURING OF THE INCISION, BOTH NEEDLE AND THREAD BROKE. A SUPPLEMENTAL SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23585607 ↗MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING INCISION CLOSURE, THE NEEDLE AND THREAD DETACHED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 23486979 ↗MalfunctionAug 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, ON SKIN CLOSURE, THE NEEDLE AND SUTURE BROKE WHILE SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22859892 ↗MalfunctionJul 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE SUTURE WAS DISCONNECTED FROM THE NEEDLE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22608749 ↗MalfunctionJul 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD. TO RESOLVE THE ISSUE, RE-SUTURING WAS PERFORMED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22590606 ↗MalfunctionJun 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN SCAR REPAIR, ON INCISION SUTURE, THE NEEDLE AND THREAD DETACHED. THE USER FIXED WITH STITCH REINFORCED STITCHING. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22342898 ↗MalfunctionJun 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A SCAR REPAIR PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 22236597 ↗MalfunctionMar 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LAPAROSCOPIC GYNECOLOGIC SURGERY, A SUTURE BROKE AT THE CONNECTION OF THE NEEDLE AND THREAD WHILE USING. 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 21522828 ↗
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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