Boston Scientific Recalls Pancreatic Stents Due to Incorrect Shelf Life Labeling
Boston Scientific is recalling 97 Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month duration.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a labeling error regarding shelf life without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Boston Scientific Corporation is recalling 97 units of the Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm (UPN: M00536660). The recall involves specific lot numbers: 21312747, 21865108, 22275742, and 24411527. These products were manufactured between September 29, 2017, and September 12, 2019.
The recall was initiated because the affected units were labeled with a 36-month shelf life, whereas the approved shelf life for these devices is 18 months. This labeling error may lead to the use of devices beyond their validated expiration dates.
The products were distributed nationwide and in several foreign countries, including Austria, Australia, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Italy, Japan, Pakistan, Poland, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, and Turkey. Healthcare providers and facilities should stop using the affected lots and contact Boston Scientific for instructions on return or replacement.
The recalled product
- Product
- Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm UPN: M00536660
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 97
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 (1)
- Lot Numbers: 21312747 21865108 22275742 24411527
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 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 13 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 · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateSPS Sterilization Recalls Boston Scientific Wallstent RP Endoprosthesis Due to Labeling Error
FDA (Devices) · 2018-09-19
- ModerateRecall of Boston Scientific Tracheobronchial Stents Due to Sterilization Labeling Error
FDA (Devices) · 2018-09-19
- ModerateBoston Scientific Recalls Stretch VL Ureteral Stent Sets Due to Tracking Issues
FDA (Devices) · 2020-04-29
- ModerateBoston Scientific Recalls Mislabeled WallFlex Biliary Stent Systems
FDA (Devices) · 2020-09-23
- ModerateBoston Scientific Recalls Mislabeled Ultraflex Tracheobronchial Stents
FDA (Devices) · 2016-05-04
- ModerateSPS Sterilization Recalls Boston Scientific Wallstent Due to Expiration Date Error
FDA (Devices) · 2018-09-19