SurgiproRecalls & reported problems across all models
Covidien LP · 62 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Surgipro model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 757
- Deaths reported
- 5
- Injuries reported
- 524
- Recalls
- 2
We found 62 models of Surgipro by Covidien LP in the FDA's device registry (GUDID). Together they are named in 757 adverse event reports in the FDA's MAUDE database, received between Mar 22, 2017 and Sep 22, 2026 — classified as 5 deaths, 524 injuries, 228 malfunctions.
The most frequently reported specific device problem is “Mechanics Altered” (237 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
Surgipro 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-2921-2026 · Root cause: Equipment maintenance · 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-1179-2023 · Root cause: Packaging process control · names 4 of these models · Recall details · FDA record ↗
Most reported Surgipro problems
Device problems
- Adverse Event Without Identified Device or Use Problem511
- Mechanics Altered237
- Migration or Expulsion of Device133
- Break128
- Detachment of Device or Device Component116
- Patient Device Interaction Problem92
- Material Integrity Problem41
- Degraded35
Patient problems
- Unspecified Tissue Injury380
- Hernia369
- Pain360
- Adhesion(s)269
- Injury267
- Emotional Changes242
- Inflammation221
- Unspecified Infection191
Surgipro models
62 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Surgipro SPM-35Mesh, surgical, polymeric1 death121 reports
- Surgipro SPM-35-WMesh, surgical, polymeric81 reports
- Surgipro SPMM-35Mesh, surgical, polymeric79 reports
- Surgipro SPMM-66Mesh, surgical, polymeric59 reports
- Surgipro CP-535SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall7 reports
- Surgipro SP-623SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall1 report
- Surgipro VP-543SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall1 report
- Surgipro CP-824SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall0 reports
- Surgipro CP-825SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall0 reports
- Surgipro SP-684SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE35 reports
- Surgipro SPM-149Mesh, surgical, polymeric1 death33 reports
- Surgipro SPM-66-WMesh, surgical, polymeric27 reports
- Surgipro SMPL-01Mesh, surgical, polymeric1 death26 reports
- Surgipro SMPM-02Mesh, surgical, polymeric1 death25 reports
- Surgipro CP-425SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE24 reports
- Surgipro SPMM-46Mesh, surgical, polymeric23 reports
- Surgipro SP-675SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE22 reports
- Surgipro CP-412SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE19 reports
- Surgipro SPMM-149Mesh, surgical, polymeric18 reports
- Surgipro CP-424SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death16 reports
- Surgipro VP-833SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE13 reports
- Surgipro CP-414SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE9 reports
- Surgipro VP-523SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE9 reports
- Surgipro SP-665SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE8 reports
- Surgipro SP-689SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE8 reports
- Surgipro SPMM-14Mesh, surgical, polymeric7 reports
- Surgipro SPM-149-WMesh, surgical, polymeric6 reports
- Surgipro SMHP-02Mesh, surgical, polymeric6 reports
- Surgipro CP-411SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE5 reports
- Surgipro SP-665GSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE5 reports
- Surgipro VP-977SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE5 reports
- Surgipro SP-631SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE4 reports
- Surgipro SP-683GSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE4 reports
- Surgipro SP-685SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE4 reports
- Surgipro SP-868GSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE4 reports
- Surgipro VP-834SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE4 reports
- Surgipro VP-945SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE4 reports
- Surgipro SP-690SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 reports
- Surgipro CP-435SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 reports
- Surgipro CP-844SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 reports
- Surgipro SP-1634SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 reports
- Surgipro SP-1697SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 reports
- Surgipro SP-683SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 reports
- Surgipro VP-736-MSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 reports
- Surgipro SMHP-01Mesh, surgical, polymeric2 reports
- Surgipro SP-1644SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 reports
- Surgipro CP-423SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- Surgipro CP-434SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- Surgipro SP-559GSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- Surgipro SP-5687SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- Surgipro SP-622-BCSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- Surgipro SP-629SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- Surgipro SP-660SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- Surgipro SP-661SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- Surgipro SP-670SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- Surgipro SP-684GSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- Surgipro SP-868SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- Surgipro VP-533SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- Surgipro VP-628SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- Surgipro VP-843SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- Surgipro SPM-14-WMesh, surgical, polymeric1 report
- Surgipro XX-5000SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
Recent Surgipro adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Detachment of Device or Device Component
According to the reporter, during a procedure, when taken out of the package the needle comes off of the thread for the two sutures. Another suture was used to resolve the issue. There was non patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50850292 ↗MalfunctionSep 22, 2026Detachment of Device or Device Component
According to the reporter, during a procedure, when taken out of the package the needle comes off of the thread for the two sutures. Another suture was used to resolve the issue. There was non patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50850278 ↗MalfunctionSep 16, 2026Detachment of Device or Device Component
According to the reporter, during the procedure, when taken out of the package the needle comes off of the thread for the two sutures. A new different suture was used to resolve the issue. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50789810 ↗MalfunctionSep 16, 2026Detachment of Device or Device Component
According to the reporter, during the procedure, when taken out of the package the needle comes off of the thread for the two sutures. A new different suture was used to resolve the issue. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50789691 ↗DeathAug 20, 2026Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem
The patient's attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a hernia. It was reported that after implant, the patient experienced emotional distress, recurrence, death. Post-operative patient treatment included revision surgery and hernia repair with new mesh. Information received indicates the patient is deceased. No information was provided regarding the circumstances of expiration.
Patient problems: Adhesion(s); Distress; Hernia; Nerve Damage; Pain; Unspecified Tissue Injury
MAUDE report 50356559 ↗DeathAug 20, 2026Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem
The patient's attorney alleged a deficiency against the device. The product was used for therapeutic treatment of an inguinal hernia. It was reported that after implant, the patient experienced adhesions, mesh migration, mesh shrinkage, nerve damage, pain, emotional distress, recurrence, death. Post-operative patient treatment included revision surgery and hernia repair with new mesh. Information received indicates the patient is deceased. No information was provided regarding the circumstances of expiration.
Patient problems: Adhesion(s); Distress; Hernia; Nerve Damage; Pain; Unspecified Tissue Injury
MAUDE report 50356523 ↗MalfunctionAug 12, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50227570 ↗MalfunctionAug 12, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50227420 ↗MalfunctionAug 12, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50227395 ↗MalfunctionAug 12, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50227374 ↗MalfunctionJul 16, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25838776 ↗MalfunctionJun 22, 2026Break; Device Slipped
ACCORDING TO THE REPORTER, IN A SURGICAL EXCISION, WHEN THE SURGEON WENT TO GENTLY WIPE THE AREA WITH ALCOHOL, THE KNOT UNRAVELED AND THE SUTURE BROKE APART IN THE MIDDLE OF THE SITE. ANOTHER SUTURE FROM A DIFFERENT BOX WAS USED BUT THE SAME ISSUE OCCURRED.
Patient problems: Insufficient Information
MAUDE report 25577599 ↗InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, PAIN, SUFFERING OPEN WOUND, ENTEROCOCCUS AND MRSA SEPSIS, & WOUND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED SURGICAL INTERVENTION, PARTIAL MESH REMOVAL, MESH REMOVAL, & WOUND CARE.
Patient problems: Bacterial Infection; Distress; Impaired Healing; Pain; Sepsis; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 25222041 ↗MalfunctionApr 1, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE LAPAROSCOPIC PARAESOPHAGEAL HERNIA PROCEDURE, THE NEEDLE DETACHED WHILE BEING REMOVED FROM THE RETAI NER. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24758761 ↗MalfunctionMar 24, 2026Break
ACCORDING TO THE REPORTER, DURING ROBOTIC LAPAROSCOPIC HYSTERECTOMY, OOPHORECTOMY, SACROCOLPOPEXY, AND LYSIS OF ADHESIONS, WHILE SUTURING, THE THREAD BROKE IN THE MIDDLE. ANOTHER SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24673847 ↗
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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