ULTRAPRO ADVANCEDRecalls & reported problems across all models
Johnson & Johnson International Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 51
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 0
We found 7 models of ULTRAPRO ADVANCED by Johnson & Johnson International Inc. in the FDA's device registry (GUDID). Together they are named in 51 adverse event reports in the FDA's MAUDE database, received between Dec 10, 2018 and Sep 24, 2026 — classified as 11 injuries, 40 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (36 reports).
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
Most reported ULTRAPRO ADVANCED problems
Device problems
- Delivered as Unsterile Product36
- Adverse Event Without Identified Device or Use Problem10
- Packaging Problem5
- Device Contaminated During Manufacture or Shipping2
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- No Consequences Or Impact To Patient5
- Pain3
- Unspecified Infection3
- Adhesion(s)2
- Fever2
- Hernia2
- Inflammation2
ULTRAPRO ADVANCED models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ULTRAPRO ADVANCED UPA31015Mesh, surgical, polymeric29 reports
- ULTRAPRO ADVANCED UPA31515Mesh, surgical, polymeric7 reports
- ULTRAPRO ADVANCED UPA3030Mesh, surgical, polymeric5 reports
- ULTRAPRO ADVANCED UPA1015Mesh, surgical, polymeric4 reports
- ULTRAPRO ADVANCED UPA37615Mesh, surgical, polymeric3 reports
- ULTRAPRO ADVANCED UPA1515Mesh, surgical, polymeric2 reports
- ULTRAPRO ADVANCED UPA3612Mesh, surgical, polymeric1 report
Recent ULTRAPRO ADVANCED adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Device Contaminated During Manufacture or Shipping
It was reported that a patient underwent a Laparoscopic tension-free repair of inguinal hernia procedure on (b)(6) 2026, and suture was used. The nurse took out a patch and opened the aluminum foil bag to find a white linear foreign object on the patch. To be safe, a new patch was used instead. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882226 ↗MalfunctionDec 15, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HERNIA REPAIR PROCEDURE ON AN (B)(6) 2025 AND MESH WAS USED. FLOCCULENT ON THE MESH. WHILE CUTTING A PATCH DURING THE OPERATION, THE CHIEF SURGEON DISCOVERED AN UNKNOWN "FLOCCULENT" OBJECT ON THE SURFACE OF THE PATCH. FOR THE SAFETY OF THE PATIENT, THE CUT PATCH WAS NOT IMPLANTED INTO THE PATIENT'S BODY. THE DOCTOR REOPENED A PIECE AND FOUND NO SIMILAR SUBSTANCE, THEN COMPLETED THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23810514 ↗MalfunctionMar 10, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2025 AND MESH WAS USED. DURING THE OPENING AND JUST BEFORE AUTHORIZING THE SURGEON TO USE THE IMPLANT, THE NURSE DISCOVERED BY INSPECTING THE ALUMINIZED PACKAGING THAT THERE WAS A SMALL HOLE IN IT, THE EDGES OF WHICH MEANT THAT THE PIERCING HAD BEEN DONE FROM THE INSIDE TO THE OUTSIDE. THE IMPLANT HAS NOT BEEN USED. NO PATIENT CONSEQUENCE. ANOTHER DEVICE WAS USED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21566912 ↗InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT REDUCTION OF INCARCERATED CECUM WITH PARTIAL OMENTECTOMY AND COMPLETE RESECTION OF INDIRECT HERNIA SAC WITH A LARGE MESH, TENSION-FREE REPAIR OF RIGHT DIRECT AND INDIRECT INGUINAL HERNIA ON (B)(6) 2022. IN EARLY 2024, THE PATIENT HAS STARTED EXPERIENCING THE FOLLOWING ISSUES: BOWEL ISSUES, CHRONIC PAIN, FEVER, GASTROINTESTINAL ISSUES, HERNIA RECURRENCE, INFECTION, INFLAMMATION, NAUSEA AND RECURRENCE. ADDITIONAL INFORMATION WAS REQUESTED,
Patient problems: Discomfort; Fever; Hernia; Inflammation; Nausea; Neuralgia; Pain; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 21152953 ↗InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT INCISIONAL HERNIA ON (B)(6) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT INCISIONAL HERNIA ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Hernia
MAUDE report 21088412 ↗InjuryNov 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REPAIR OF VENTRAL INCISIONAL HERNIA ON (B)(6) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY AND RECURRENT VENTRAL INCISIONAL REPAIR ON (B)(6) 2019 WITH LYSIS OF ADHESIONS, SMALL BOWEL RESECTION DURING WHICH THE SURGEON NOTED INTRAABDOMINAL ADHESIONS SECONDARY TO DUAL MESH. THE MESH WAS TUCKED TO THE ABDOMEN WALL ALONG WITH A SMALL BOWEL TO THE MESH REQUIRING RESECTION. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT VENTRAL INCISIONAL HERNIA REPAIR ON (B)(6) 2020. IT WAS REPORTED THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20647027 ↗InjuryNov 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REPAIR OF VENTRAL INCISIONAL HERNIA ON (B)(6) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY AND RECURRENT VENTRAL INCISIONAL REPAIR ON (B)(6) 2019 WITH LYSIS OF ADHESIONS, SMALL BOWEL RESECTION DURING WHICH THE SURGEON NOTED INTRAABDOMINAL ADHESIONS SECONDARY TO DUAL MESH. THE MESH WAS TUCKED TO THE ABDOMEN WALL ALONG WITH A SMALL BOWEL TO THE MESH REQUIRING RESECTION. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT VENTRAL INCISIONAL HERNIA REPAIR ON (B)(6) 2020. IT WAS REPORTED THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20646913 ↗MalfunctionOct 1, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE AROUND (B)(6) 2024 AND MESH WAS USED. THE NURSE IN THE OR TAKES THE MESH OUT OF THE ENVELOPE IT IS IN. (THEY ARE PACKED 3 PIECES IN THE SAME ENVELOPE). OPENS THE NEXT PACKAGE THAT IS MADE OF SOME KIND OF FOIL. OR NURSE TAKES THE MESH OUT OF THE PACKAGE. USK THEN OPENS UP THE ENTIRE PACKAGE AND EYES IT AGAINST A LIGHT SOURCE IN THE CEILING, THEREBY DETECTING TINY, MICROSCOPIC HOLES. THE NET IS DISCARDED BECAUSE STERILITY CANNOT BE GUARANTEED. THERE WAS ONE PRETTY "BIG" HOLE SO IT CAN BE SEEN WELL OTHERWISE THEY CAN BE SO SMALL THAT IT IS DIFFICULT TO DETECT AND IF YOU DO NOT USE A LIGHT SOURCE WHEN YOU LOOK AT THE PACKAGING, THE HOLES PROBABLY GO UNNOTICED. NEW MESH IS OPENED AND UNDERGO THE SAME INSPECTION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20344169 ↗MalfunctionOct 1, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE AROUND (B)(6) 2024 AND MESH WAS USED. THE NURSE IN THE OR TAKES THE MESH OUT OF THE ENVELOPE IT IS IN. (THEY ARE PACKED 3 PIECES IN THE SAME ENVELOPE). OPENS THE NEXT PACKAGE THAT IS MADE OF SOME KIND OF FOIL. OR NURSE TAKES THE MESH OUT OF THE PACKAGE. USK THEN OPENS UP THE ENTIRE PACKAGE AND EYES IT AGAINST A LIGHT SOURCE IN THE CEILING, THEREBY DETECTING TINY, MICROSCOPIC HOLES. THE NET IS DISCARDED BECAUSE STERILITY CANNOT BE GUARANTEED. THERE WAS ONE PRETTY "BIG" HOLE SO IT CAN BE SEEN WELL OTHERWISE THEY CAN BE SO SMALL THAT IT IS DIFFICULT TO DETECT AND IF YOU DO NOT USE A LIGHT SOURCE WHEN YOU LOOK AT THE PACKAGING, THE HOLES PROBABLY GO UNNOTICED. NEW MESH IS OPENED AND UNDERGO THE SAME INSPECTION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20344161 ↗MalfunctionOct 1, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE AROUND (B)(6) 2024 AND MESH WAS USED. THE NURSE IN THE OR TAKES THE MESH OUT OF THE ENVELOPE IT IS IN. (THEY ARE PACKED 3 PIECES IN THE SAME ENVELOPE). OPENS THE NEXT PACKAGE THAT IS MADE OF SOME KIND OF FOIL. OR NURSE TAKES THE MESH OUT OF THE PACKAGE. USK THEN OPENS UP THE ENTIRE PACKAGE AND EYES IT AGAINST A LIGHT SOURCE IN THE CEILING, THEREBY DETECTING TINY, MICROSCOPIC HOLES. THE NET IS DISCARDED BECAUSE STERILITY CANNOT BE GUARANTEED. THERE WAS ONE PRETTY "BIG" HOLE SO IT CAN BE SEEN WELL OTHERWISE THEY CAN BE SO SMALL THAT IT IS DIFFICULT TO DETECT AND IF YOU DO NOT USE A LIGHT SOURCE WHEN YOU LOOK AT THE PACKAGING, THE HOLES PROBABLY GO UNNOTICED. NEW MESH IS OPENED AND UNDERGO THE SAME INSPECTION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20344128 ↗MalfunctionSep 20, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND MESH WAS USED. THE HEALTHCARE PROFESSIONAL DISCOVERED SMALL HOLES IN THE FOIL PACK OF THE MESH WHICH LOOKS LIKE PUNCH HOLES. IT IS MICROSCOPICAL, BUT DETECTABLE IN A DARK ROOM WITH LIGHTS THROUGH. NO HOLES WERE DETECTED ON THE OUTER PAPER BOX. THERE WAS NO DELAY DUE TO THE REPORTED EVENT AND NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20273033 ↗MalfunctionSep 20, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND MESH WAS USED. THE HEALTHCARE PROFESSIONAL DISCOVERED SMALL HOLES IN THE FOIL PACK OF THE MESH WHICH LOOKS LIKE PUNCH HOLES. IT IS MICROSCOPICAL, BUT DETECTABLE IN A DARK ROOM WITH LIGHTS THROUGH. NO HOLES WERE DETECTED ON THE OUTER PAPER BOX. THERE WAS NO DELAY DUE TO THE REPORTED EVENT AND NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20273010 ↗MalfunctionSep 20, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND MESH WAS USED. THE HEALTHCARE PROFESSIONAL DISCOVERED LARGER HOLE IN THE FOIL PACK OF THE MESH. NO HOLES WERE DETECTED ON THE OUTER PAPER BOX. THERE WAS NO DELAY DUE TO THE REPORTED EVENT AND NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20272937 ↗MalfunctionSep 20, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND MESH WAS USED. THE HEALTHCARE PROFESSIONAL DISCOVERED SMALL HOLES IN THE FOIL PACK OF THE MESH WHICH LOOKS LIKE PUNCH HOLES. IT IS MICROSCOPICAL, BUT DETECTABLE IN A DARK ROOM WITH LIGHTS THROUGH. NO HOLES WERE DETECTED ON THE OUTER PAPER BOX. THERE WAS NO DELAY DUE TO THE REPORTED EVENT AND NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20272793 ↗MalfunctionSep 20, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND MESH WAS USED. THE HEALTHCARE PROFESSIONAL DISCOVERED SMALL HOLES IN THE FOIL PACK OF THE MESH WHICH LOOKS LIKE PUNCH HOLES. IT IS MICROSCOPICAL, BUT DETECTABLE IN A DARK ROOM WITH LIGHTS THROUGH. NO HOLES WERE DETECTED ON THE OUTER PAPER BOX. THERE WAS NO DELAY DUE TO THE REPORTED EVENT AND NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20272786 ↗
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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