ORISE ProKnife recallZ-0226-2023 · Boston Scientific Corporation · initiated Oct 10, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
***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
FDA root cause category: Under Investigation by firm
What the company is doing
***UPDATE 12/13/22** Boston Scientific issued Urgent Medical Device Product Removal Immediate Action Required Orise" Gel Submucosal Lifting Agent via Federal Express Priority Overnight mail on December 14, 2022, (as a Follow-Up To The Previous Product Advisory Dated October 10, 2022). Letter states reason for recall (Product Removal), health risk and action to take: Use and distribution of any remaining unused ORISE Gel Submucosal Lifting Agent products affected by this removal should cease immediately. For patients already treated with ORISE Gel, should the user identify submucosal distortions or mass formations in follow-up endoscopy, endoscopic ultrasound, imaging, or surgery, Boston Scientific recommends taking into account prior ORISE Gel use. Review pathology reports from the prior procedure to help determine the most appropriate course of action. Depending on the pathology present during the initial use of ORISE Gel, and whether it included conditions such as adenoma, high-grade dysplasia, or malignancy, a user may need to do nothing, repeat surveillance, repeat a biopsy, perform further mucosal resection, or plan surgical intervention to rule out any residual lesion. For each patient treated with ORISE Gel, Boston Scientific recommends appending their medical record with a copy of this letter to maintain awareness of this topic. If you identify any product from the affected lots within your inventory, please segregate the product immediately and return it to Boston Scientific in accordance with the enclosed Removal Instructions. If you are a distributor, please note that the depth of this removal is to the end user level and this notification should be forwarded to your customers. If you are a facility that has sent products to another hospital or facility within your network, please ensure that this notification is forwarded to them. Your local Sales Representative can answer any questions that you may have regarding this notification. _________________
Recall details
- Recall number
- Z-0226-2023
- Status
- Open, Classified
- Initiated by the company
- Oct 10, 2022
- Posted by the FDA
- Nov 11, 2022
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 402,968 Total
- Product code
- FBK
- FDA submissions
- K171454
- 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
Product description
ORISE ProKnife Procedure 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)ORISE ProKnife 1.5 mm Electrode - Kit M00519380; (2) ORISE ProKnife 2.0 mm Electrode - Kit M00519390; (3) ORISE ProKnife 3.0 mm Electrode - Kit M00519400
Code information (models, lots, serial numbers)
GTIN Number : (1)08714729995586 (2)08714729995593 (3)08714729995609 All batches
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- ORISE™ ProKnife M00519390Boston Scientific Corporation · Unit, electrosurgical, endoscopic (with or without accessories)1 recall1 report
- ORISE™ ProKnife M00519380Boston Scientific Corporation · Unit, electrosurgical, endoscopic (with or without accessories)1 recall0 reports
- ORISE™ ProKnife M00519400Boston Scientific Corporation · Unit, electrosurgical, endoscopic (with or without accessories)1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 90986).
- Z-0224-2023 · Open, ClassifiedORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointesti…
- Z-0225-2023 · Open, ClassifiedORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other g…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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