ULTRAPRORecalls & reported problems across all models
Johnson & Johnson International Inc. · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 134
- Deaths reported
- 0
- Injuries reported
- 121
- Recalls
- 0
We found 18 models of ULTRAPRO by Johnson & Johnson International Inc. in the FDA's device registry (GUDID). Together they are named in 134 adverse event reports in the FDA's MAUDE database, received between Mar 7, 2018 and Jan 15, 2026 — classified as 121 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Migration” (9 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 problems
Device problems
- Adverse Event Without Identified Device or Use Problem105
- Migration9
- Appropriate Device Problem Term/Code Not Available5
- Device Markings/Labelling Problem4
- Material Integrity Problem3
- Material Split, Cut or Torn3
- Delivered as Unsterile Product2
- Break1
Patient problems
- Pain50
- Adhesion(s)22
- Hernia21
- Inflammation19
- Injury18
- Unspecified Infection18
- Not Applicable17
- Swelling/ Edema15
ULTRAPRO models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ULTRAPRO UMM3Mesh, surgical, polymeric18 reports
- ULTRAPRO UMS3Mesh, surgical, polymeric17 reports
- ULTRAPRO UHSLMesh, surgical, polymeric14 reports
- ULTRAPRO UMR3Mesh, surgical, polymeric14 reports
- ULTRAPRO UMM3Mesh, surgical, polymeric13 reports
- ULTRAPRO UML1Mesh, surgical, polymeric9 reports
- ULTRAPRO UMR3Mesh, surgical, polymeric7 reports
- ULTRAPRO UHSMMesh, surgical, polymeric5 reports
- ULTRAPRO UHSL6Mesh, surgical, polymeric5 reports
- ULTRAPRO UPPS6Mesh, surgical, polymeric5 reports
- ULTRAPRO UPPS1Mesh, surgical, polymeric4 reports
- ULTRAPRO UMS3Mesh, surgical, polymeric4 reports
- ULTRAPRO UPPL6Mesh, surgical, polymeric4 reports
- ULTRAPRO UPPM6Mesh, surgical, polymeric4 reports
- ULTRAPRO UPPL2Mesh, surgical, polymeric3 reports
- ULTRAPRO UPPS2Mesh, surgical, polymeric3 reports
- ULTRAPRO UHSOVMesh, surgical, polymeric3 reports
- ULTRAPRO UPPM2Mesh, surgical, polymeric2 reports
Recent ULTRAPRO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT REVISION SURGERY AND MESH WAS IMPLANTED ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2021 AND TWO MESHES WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT REMOVAL SURGERY ON (B)(6) 2023. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Pain
MAUDE report 24085280 ↗MalfunctionAug 14, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND MESH WAS USED. WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THERE WERE SOME MESH FRAGMENTS INSIDE THE PACKAGE, WHICH WAS NOTICED DURING THE PROCEDURE AND THE USE WAS STOPPED. AS SIMILAR CASES HAD OCCURRED WITH BOTH OF PRODUCTS IN STOCK, SO THEIR USE WAS STOPPED. THE DEVICE WAS NOT USED FOR THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22810276 ↗MalfunctionAug 14, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND MESH WAS USED. WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THERE WERE SOME MESH FRAGMENTS INSIDE THE PACKAGE, WHICH WAS NOTICED DURING THE PROCEDURE AND THE USE WAS STOPPED. AS SIMILAR CASES HAD OCCURRED WITH BOTH OF PRODUCTS IN STOCK, SO THEIR USE WAS STOPPED. THE DEVICE WAS NOT USED FOR THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22810273 ↗InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2009 AND TWO (2) MESH WERE IMPLANTED. IT WAS ALSO PREVIOUSLY REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESION AND PAIN. OTHER PROCEDURE WAS CAPTURED ON A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Adhesion(s); Pain
MAUDE report 22687028 ↗InjuryJul 31, 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 REVISION SURGERY ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2009 AND TWO (2) MESH WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESION AND PAIN. OTHER PROCEDURE WAS CAPTURED ON A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Adhesion(s); Pain
MAUDE report 22674982 ↗InjuryJul 8, 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 HERNIA REPAIR SURGERY ON (B)(6) 2016 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AND ADHESION. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Adhesion(s); Pain
MAUDE report 22453999 ↗InjuryJun 5, 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 INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2023 AND MESH WAS IMPLANTED. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2022 AND MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22147948 ↗InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY FOR A PARASTOMAL HERNIA FOLLOWING A CYSTECTOMY WITH AN ILEAL CONDUIT ON AN UNKNOWN DATE AND MESH WAS USED. THE PATIENT HAD A POTENTIAL ALLERGIC REACTION. THE WOUND BECAME INFECTED AND HAD TO BE TREATED AGAIN THIS YEAR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Hypersensitivity/Allergic reaction; Impaired Healing; Post Operative Wound Infection
MAUDE report 22109877 ↗InjuryApr 8, 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 REVISION SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HERNIA RECURRENCE, TINGLING SENSATION IN THE GROIN, ADHESIONS IN THE PROPERITONEAL SPACE, DENSE SIGNIFICANT SCAR TISSUE, MESHOMA AT THE INTERNAL RING - MESH CONTRACTION, AND MESH SHRINKAGE. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Scar Tissue
MAUDE report 21802469 ↗InjuryApr 2, 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 HERNIA REPAIR SURGERY AND A MESH WAS IMPLANTED ON (B)(6) 2014. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2009 AND A MESH WAS IMPLANTED. NO OTHER INFORMATION WAS PROVIDED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE.
Patient problems: Insufficient Information
MAUDE report 21759309 ↗InjuryMar 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA SURGERY ON (B)(6) 2015 AND ONE(1) MESH AND TWO(2) MESHES WERE IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21674598 ↗InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA SURGERY ON (B)(6) 2011 AND A MESH AND ANOTHER MESH WERE IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21627914 ↗InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT REPAIR OF INCARCERATED RECURRENT INCISIONAL HERNIA ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAINFUL INCARCERATED EPIGASTRIC UPPER ABDOMINAL VENTRAL HERNIA. IT WAS PREVIOUSLY REPORTED THAT PATIENT HAD UNDERWENT HERNIA REPAIR ON (B)(6) 2016 AND MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Hernia; Pain
MAUDE report 21603650 ↗InjuryMar 12, 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 RIGHT INGUINAL HERNIA AND MESH WAS IMPLANTED ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR AND MESH WAS IMPLANTED ON (B)(6) 2011. NO OTHER INFORMATION WAS PROVIDED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21590561 ↗InjuryFeb 18, 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 HERNIA REPAIR ON(B)(6)2020 AND MESH WAS IMPLANTED. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD HERNIA REPAIR ON (B)(6)2013 AND MESH WAS IMPLANTED. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD HERNIA REPAIR ON (B)(6)2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, NAUSEA, VOMITING, TENDERNESS, AND ADHESIONS. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO OTHER INFORMATION CAN BE ADDED
Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Nausea; Pain; Vomiting
MAUDE report 21395562 ↗
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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