PROCEEDRecalls & reported problems across all models
Johnson & Johnson International Inc. · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4,285
- Deaths reported
- 1
- Injuries reported
- 4,160
- Recalls
- 1
We found 13 models of PROCEED by Johnson & Johnson International Inc. in the FDA's device registry (GUDID). Together they are named in 4,285 adverse event reports in the FDA's MAUDE database, received between Sep 3, 2015 and Jun 8, 2026 — classified as 1 death, 4,160 injuries, 124 malfunctions.
The most frequently reported specific device problem is “Migration” (79 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
PROCEED 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.
- Oct 23, 2020Terminated
The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit.
Z-0533-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported PROCEED problems
Device problems
- Adverse Event Without Identified Device or Use Problem4,002
- Appropriate Device Problem Term/Code Not Available82
- Migration79
- Material Split, Cut or Torn25
- Material Disintegration17
- Material Separation17
- Detachment of Device or Device Component16
- Material Integrity Problem16
Patient problems
- Pain2,775
- Inflammation2,085
- Adhesion(s)1,904
- Hernia1,401
- Nausea1,383
- Decreased Appetite778
- Diarrhea775
- Chills733
PROCEED models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PROCEED PVPMMesh, surgical, polymeric1,233 reports
- PROCEED PCDN1Mesh, surgical, polymeric744 reports
- PROCEED PCDG1Mesh, surgical, polymeric1 recall1 death637 reports
- PROCEED PVPSMesh, surgical, polymeric622 reports
- PROCEED PCDH1Mesh, surgical, polymeric421 reports
- PROCEED PCDM1Mesh, surgical, polymeric154 reports
- PROCEED PCDT1Mesh, surgical, polymeric122 reports
- PROCEED PCDJ1Mesh, surgical, polymeric103 reports
- PROCEED PCDR1Mesh, surgical, polymeric80 reports
- PROCEED PCDB1Mesh, surgical, polymeric54 reports
- PROCEED PCDW1Mesh, surgical, polymeric43 reports
- PROCEED PCDD1Mesh, surgical, polymeric42 reports
- PROCEED PCDL1Mesh, surgical, polymeric30 reports
Recent PROCEED adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT BILATERAL INGUINAL AND UMBILICAL HERNIA REPAIR ON (B)(6) 2013 AND MESH AND MESH WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 25438377 ↗InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT SURGERY, A REPAIR OF RECURRENT INCISIONAL HERNIA ON 05/03/2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 25390496 ↗InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A HERNIA REPAIR ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 25387180 ↗InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A REPAIR SUPRAUMBILICAL INCISIONAL HERNIA, VENTRAL ON (B)(6) 2023 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 25373850 ↗InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT UMBILICAL HERNIA REPAIR ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT EXPERIENCED FIRM BULGE SUPRAUMBILICAL WITH PAIN. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Pain; Swelling/ Edema
MAUDE report 25372136 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A HERNIA REPAIR ON (B)(6) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESIONS. NO ADDITIONAL INFORMATION CAN BE ADDED. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Adhesion(s)
MAUDE report 25298411 ↗InjuryMay 25, 2026Adverse Event Without Identified Device or Use Problem
DETAILS: IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2005 AND TWO(2) MESHES WERE IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25272224 ↗InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND MESH WAS USED. POST-OP, THE PATIENT EXPERIENCED AN INFECTION - FUNGAL. THE PATIENT REPORTED PAIN AND DISCOMFORT. THE PATIENT UNDERWENT RE-OPERATION, A LAPAROTOMY FOR REMOVAL OF MESH. THE PATIENT HAS HAD ONGOING WOUND COMPLICATIONS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Discomfort; Pain; Unspecified Infection
MAUDE report 25151178 ↗InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY OF PREVIOUSLY PLACED MESH ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2019 DURING WHICH THE SURGEON NOTED THE MESH TO BE ESSENTIALLY FROZEN WITH ADHESIONS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED DENSE ADHESIONS, SMALL BOWEL OBSTRUCTIONS, INFECTIONS, NAUSEA, VOMITING, CHRONIC INTRACTABLE ABDOMINAL PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Abdominal Pain; Adhesion(s); Hernia; Nausea; Obstruction/Occlusion; Unspecified Infection; Vomiting
MAUDE report 25077663 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT UMBILICAL HERNIA REPAIR ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT EXPERIENCED WOUND INFECTION. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Post Operative Wound Infection
MAUDE report 25034986 ↗MalfunctionApr 29, 2026Material Disintegration
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND MESH WAS USED. IT WAS REPORTED THAT THE MESH CRUMBLED APART AS SOON AS WE TRIED TO INSERT IT INTO THE PATIENT, AND WE COULDN'T USE IT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25031311 ↗InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT SURGERY A LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2021 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 24925989 ↗InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SCARRING, DISFIGUREMENT AND CHRONIC PAIN. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Deformity/ Disfigurement; Pain; Scar Tissue
MAUDE report 24925700 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A HERNIA REPAIR SURGERY ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016. IT WAS REPORTED THAT PATIENT EXPERIENCED ADHESION AND HERNIA. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Adhesion(s); Hernia
MAUDE report 24719303 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 24646036 ↗
Other Johnson & Johnson International Inc. products
All Johnson & Johnson International Inc. devices →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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