CLASS II ONGOING Device recall · Reported 16 Nov 2022 · FDA Enforcement Report

Orise Gel Syringe Submucosal Lifting Agent Kits recalled

Boston Scientific is recalling Orise Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal, distributed nationwide in the US. The recall was initiated on 10 Oct 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN Number : (1)08714729974581 (2)08714729974598 (3)08714729993865 All batches

Quantity recalled402,968 Total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0225-2023
FDA event ID: 90986
Recalling firm: Boston Scientific, Marlborough, MA
Classification: Class II
Status: Ongoing
Recall initiated: 10 Oct 2022
FDA classified: 10 Nov 2022
Reported: 16 Nov 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

10 Oct 2022	Recall initiated by company
10 Nov 2022	Classified by FDA	+31 days
16 Nov 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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

Where it was distributed

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

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

GTIN Number : (1)08714729974581 (2)08714729974598 (3)08714729993865 All batches

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 90986

This product is part of a recall event; the main page for the event is Orise Gel Submucosal Lifting Agent--Indicated for use recalled.

Reported	Class	Recall	Company	Reason	Where
16 Nov 2022	CLASS II	Orise Gel Submucosal Lifting Agent--Indicated for use recalled	Boston Scientific	Packaging Defects	Nationwide
16 Nov 2022	CLASS II	Orise ProKnife Procedure Kits: indicated for use recalled	Boston Scientific	Other	Nationwide

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