Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity Issues
Boston Scientific is recalling TWISTER PLUS 22mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterility may be compromised, posing a risk of harm (infection) without reported injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling the TWISTER PLUS 22mm Rotatable Retrieval Device (UPN: M00561410). The device is intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses. The recall involves specific lot numbers: H13061101, H13062403, H13062404, and H13071301.
The recall is being conducted because the sterility of the device may be compromised due to a lack of pouch seal integrity. The devices were distributed worldwide, including in the United States, Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and the Netherlands.
Healthcare facilities and consumers who have these specific devices should stop using them and contact Boston Scientific for instructions on how to return or replace the product.
The recalled product
- Product
- TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN): M00561410. Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. Intended to be used in flexible endoscopes as a retrieval device for foreign…
- Manufacturer
- Boston Scientific Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Numbers: H13061101
- H13062403
- H13062404
- H13071301
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateBoston Scientific Recalls Flexima Duodenal Bend Biliary Stent Due to Packaging Defects
FDA (Devices) · 2019-03-20
- LowBoston Scientific Recalls Captivator II Polypectomy Snares Due to Incomplete Seals
FDA (Devices) · 2021-03-10
- HighBoston Scientific Recalls Polaris Ultra Ureteral Stent Sets
FDA (Devices) · 2020-04-29
- HighBoston Scientific Recalls Pediatric Polypectomy Snares Due to Extension Difficulty
FDA (Devices) · 2012-06-27
- LowBoston Scientific Recalls Polypectomy Snares Due to Incomplete Pouch Seals
FDA (Devices) · 2021-03-10
- HighBoston Scientific HYDRATOME RX Device Recalled Due to Sterile Barrier Breach
FDA (Devices) · 2022-03-23