# FDA recall Z-0224-2023

> **Boston Scientific Corporation** · Class II · device recall initiated 2022-10-10.

## Product

ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps,  adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device  Packaged as follows:                                                                                          UPN:  (1)Twin Pack  Box 1									M00519200								  (2)Twin Pack  Box 10								M00519201								  (3)Single Pack   Box 1								M00519220								  (4)Single Pack   Box 10								M00519221

## Reason for recall

***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions***  Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which presented as mass formations from remnant ORlSE Gel post-procedure, prompting  surgical intervention

## Distribution

Worldwide Distribution: US (Nationwide) and (Foreign) countries of: Algeria Argentina Argentina Australia Austria Bahrain Belgium Brazil Canada Chile Colombia Costa Rica Cyprus Czech Republic Denmark Ecuador Egypt Finland France Germany Great Britain Greece Hong Kong Hungary Iceland Iraq Ireland Israel Italy Jordan Kuwait Latvia Lebanon Lithuania Luxembourg Mexico Netherlands New Zealand Norway Oman Palestine Panama Per¿ Poland Portugal Romania Russian Fed. Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Tunisia Unit.Arab Emir. Zimbabwe

## Key facts

- **Recall number:** Z-0224-2023
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-10-10
- **Report date:** 2022-11-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0224-2023

## Citation

> AI Analytics. FDA recall Z-0224-2023. Retrieved 2026-09-16 from https://api.ai-analytics.org/recall/Z-0224-2023. Source: US FDA. Licensed CC0.

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