ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in… — Class II medical device recall Z-0225-2023
Ongoing recall by Boston Scientific Corporation, reported 2022-11-16, distributed nationwide. ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Po
| Recall number | Z-0225-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2022-10-10 |
| Classified | 2022-11-10 |
| Reported by FDA | 2022-11-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BH, BR, CA, CH, CL, CO, CR, CY, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GR, HK, HU, IE, IL, IQ, IS, IT, JO, KW, LB, LT, LU, LV, MX, NL, NO, NZ, OM, PA, PL, PT, RO, SA, SE, SG, SI, SK, TH, TN, TW, ZA |
| Quantity | 402,968 total |
| Reason classes | foreign material |
| UPC / GTIN / UDI-DI | 08714729974581, 08714729974598, 08714729993865 |
Product
ORISE Gel Syringe Submucosal Lifting Agent Kits: 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 UPN: (1)Twin Pack Box 1 M00519210; (2)Twin Pack Box 10 M00519211; (3)Single Pack Box 10 M00519231
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0225-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.