OviTex® 1S F10256-0610GRecalls & reported problems

Aroa Biosurgery Limited · The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. OviTex Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device remodels and helps regenerate tissue while reinforcing the repair and providing structural support. Reinforced tissue matrices enhance performance while maintaining compatibility with the body. The OviTex Reinforced Tissue Matrix Device is used for hernia repair and abdominal wall reconstruction. · Class 2 · Implant

All models of OviTex 1S (12)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09421904065291), received between Jul 17, 2026 and Jul 27, 2026 — classified as 2 injuries.

21 other recalls cover devices cleared under the same FDA submission (K153633); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem2

Patient problems

Dysphagia/ Odynophagia2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
A patient underwent paraesophageal hernia repair with OviTex 1S Resorbable on (b)(6) 2026. The patient reported ongoing difficulty advancing beyond a full liquid diet and on 11May26 reported weight loss but overall dysphagia improvement. On (b)(6) 2026 the patient reported worsening dysphagia with associated PO intolerance. The patient was admitted to the hospital on (b)(6) 2026 with diagnostic and therapeutic upper endoscopy on (b)(6) 2026 where a retained food bolus was identified in the distal esophagus with mild narrowing of the distal esophagus. A balloon dilation was performed after bolus removal and the patient discharged on (b)(6) 2026. The patient reported in (b)(6) 2026 ongoing improvement in symptoms and appropriate advancement of diet.
Patient problems: Dysphagia/ Odynophagia
MAUDE report 50018969 ↗
InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem
A PATIENT UNDERWENT PARAESOPHAGEAL HERNIA REPAIR WITH OVITEX 1S RESORBABLE ON (B)(6) 2026. ON (B)(6) 2026 THE PATIENT REPORTED WORSENING DYSPHAGIA WITH ASSOCIATED PO INTOLERANCE. UPPER GI IMAGING WAS CONDUCTED ON (B)(6) 2026 WHICH DEMONSTRATED DELAYED ESOPHAGEAL EMPTYING AND NARROWING AT THE GE JUNCTION. THE PATIENT UNDERWENT EGD WITH BALLOON DILATION ON (B)(6) 2026 AND (B)(6) 2026 WITH NO ADDITIONAL INTERVENTIONS NOTED.
Patient problems: Dysphagia/ Odynophagia
MAUDE report 25854210 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153633. One submission often covers many models, so check the product and lot details in each record.

Z-0431-2019 · Apr 6, 2018 · Terminated
OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G
Z-0427-2019 · Apr 6, 2018 · Terminated
OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G
Z-0432-2019 · Apr 6, 2018 · Terminated
OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G
Z-0433-2019 · Apr 6, 2018 · Terminated
OviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020G
Z-0428-2019 · Apr 6, 2018 · Terminated
OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G
Z-0425-2019 · Apr 6, 2018 · Terminated
OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G
Z-0423-2019 · Apr 6, 2018 · Terminated
OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G
Z-0422-2019 · Apr 6, 2018 · Terminated
OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G
Z-0416-2019 · Apr 6, 2018 · Terminated
OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G
Z-0420-2019 · Apr 6, 2018 · Terminated
OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G
Z-0434-2019 · Apr 6, 2018 · Terminated
OviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822G
Z-0430-2019 · Apr 6, 2018 · Terminated
OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G
Z-0424-2019 · Apr 6, 2018 · Terminated
OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G
Z-0435-2019 · Apr 6, 2018 · Terminated
OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
Z-0417-2019 · Apr 6, 2018 · Terminated
OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G

…and 6 more.

Device details

UDI-DI	`09421904065291`
Brand	OviTex® 1S
Model	F10256-0610G
Company	Aroa Biosurgery Limited
Product code	FTM · Mesh, Surgical
Class	Class 2
FDA submission	K153633
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	May 18, 2026

Device type (GMDN): Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

A bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh.

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All Mesh, Surgical devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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