Recalls in December 2025
421 recalls.
- NexxZr T Multi A3.5 W98-16mm recall (Sagemax Bioceramics, Inc.)
Medical deviceClass IIReported June 17, 2026 · Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the... - Betaine Anhydrous recall (Creative Compounds, LLC)
FoodClass IIReported June 10, 2026 · Possible carbon steel foreign material (1-2mm) - Phothera 200 recall (Daavlin Distributing Company)
Medical deviceClass IIReported June 10, 2026 · Some of the Calibration/Output Certificates had the outputs reversed. - TPN bag recall (Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles)
DrugClass IIReported May 13, 2026 · Incorrect Product Formulation: product did not contain insulin as listed in the label. - WHILL Model F recall (WHILL, INC.)
Medical deviceClass IReported May 6, 2026 · Cyber vulnerability of BLE communication was found by CISA VDP program. - WHILL Model C2 recall (WHILL, INC.)
Medical deviceClass IReported May 6, 2026 · Cyber vulnerability of BLE communication was found by CISA VDP program. - CHIPS AHOY! Baked Bites Brookie .22.4 oz Carton recall (Mondelez Global Llc)
FoodClass IIReported April 29, 2026 · Hard corn starch lumps were found in the product - Brand Name: da Vinci S recall (Intuitive Surgical, Inc.)
Medical deviceClass IIReported April 8, 2026 · Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments - Brand Name: da Vinci S recall (Intuitive Surgical, Inc.)
Medical deviceClass IIReported April 8, 2026 · Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments - Brand Name: da Vinci S recall (Intuitive Surgical, Inc.)
Medical deviceClass IIReported April 8, 2026 · Due to increased complaints for broken/frayed grip cables for reusable instruments. - Brand Name: da Vinci S recall (Intuitive Surgical, Inc.)
Medical deviceClass IIReported April 8, 2026 · Due to increased complaints for broken/frayed grip cables for reusable instruments. - Brand Name: da Vinci S recall (Intuitive Surgical, Inc.)
Medical deviceClass IIReported April 8, 2026 · Due to increased complaints for broken/frayed grip cables for reusable instruments. - Brand Name: da Vinci S recall (Intuitive Surgical, Inc.)
Medical deviceClass IIReported April 8, 2026 · Due to increased complaints for broken/frayed grip cables for reusable instruments. - Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal... recall (Altruan GmbH)
Medical deviceClass IIReported March 18, 2026 · Product not cleared by the FDA. - Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci recall (Altruan GmbH)
Medical deviceClass IIReported March 18, 2026 · Product not cleared by the FDA. - Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic... recall (Altruan GmbH)
Medical deviceClass IIReported March 18, 2026 · Product not cleared by the FDA. - MR. 7 SUPER 700000 capsules recall (StuffbyNainax)
DrugClass IReported March 11, 2026 · Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil - Gelsoft Plus recall (Vascutek, Ltd.)
Medical deviceClass IIReported March 11, 2026 · Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry... - BioGlo Fluorescein Sodium Ophthalmic Strips USP recall (Wizcure Pharmaa Private Limited)
DrugClass IIReported March 4, 2026 · Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. - Bio Glo Fluorescein Sodium Ophthalmic Strips USP recall (Wizcure Pharmaa Private Limited)
DrugClass IIReported March 4, 2026 · Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. - CHNaO Fluorescein Sodium Ophthalmic Strips recall (Wizcure Pharmaa Private Limited)
DrugClass IIReported March 4, 2026 · Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. - Vista Gonio Eye Lubricant recall (Wizcure Pharmaa Private Limited)
DrugClass IIReported March 4, 2026 · Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. - Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief... recall (Wizcure Pharmaa Private Limited)
DrugClass IIReported March 4, 2026 · Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. - Vista Gel Hypromellose USP 0.3% w/v recall (Wizcure Pharmaa Private Limited)
DrugClass IIReported March 4, 2026 · Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. - Vista Tears Polyethylene Glycol 400 0.4% w/v recall (Wizcure Pharmaa Private Limited)
DrugClass IIReported March 4, 2026 · Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. - Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software... recall (Centinel Spine, Inc.)
Medical deviceClass IIReported February 25, 2026 · Products were mislabeled as the 6mm product but included the 5 mm product. - Medica Capillary Tubes recall (Medica Corporation)
Medical deviceClass IIReported February 25, 2026 · A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when... - Estrone RIA recall (Immunotech A.S.)
Medical deviceClass IIReported February 25, 2026 · The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very... - Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth... recall (Bard Peripheral Vascular Inc)
Medical deviceClass IIReported February 25, 2026 · Due to damage to outer tray that can potentially compromise the sterile barrier - Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and... - Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI... recall (Wilson-Cook Medical Inc.)
Medical deviceClass IIReported February 25, 2026 · Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current... - da Vinci 5 Surgeon Console Viewer Display recall (Intuitive Surgical, Inc.)
Medical deviceClass IIReported February 18, 2026 · Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth... - Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system... recall (Elekta, Inc.)
Medical deviceClass IIReported February 18, 2026 · Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This... - Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system... recall (Elekta, Inc.)
Medical deviceClass IIReported February 18, 2026 · Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This... - Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: STERILE RESUTURE PACK recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - 1) UNIVERSAL KIT recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav... recall (Medline Industries, LP)
Medical deviceClass IReported February 18, 2026 · These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response... - Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: ... recall (Medline Industries, LP)
Medical deviceClass IReported February 18, 2026 · These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response... - Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter... recall (Medline Industries, LP)
Medical deviceClass IReported February 18, 2026 · These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response... - Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: ... recall (Medline Industries, LP)
Medical deviceClass IReported February 18, 2026 · These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response... - Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire... recall (Medline Industries, LP)
Medical deviceClass IReported February 18, 2026 · These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response... - Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry... recall (Medline Industries, LP)
Medical deviceClass IReported February 18, 2026 · These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response... - Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes... recall (Medline Industries, LP)
Medical deviceClass IReported February 18, 2026 · These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response... - Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. recall (Hologic, Inc)
Medical deviceClass IIReported February 18, 2026 · Presence of particulates in affected devices that can be deposited into breast tissue during use. - Intubation Tray recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the... - Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the... - Swiss Chocolate Cake Mix recall (B.C. Williams Bakery Service, Inc)
FoodClass IReported February 11, 2026 · Undeclared Milk Allergen - Bread and Roll Mix recall (B.C. Williams Bakery Service, Inc)
FoodClass IReported February 11, 2026 · Undeclared Milk Allergen - Spice Cake Mix recall (B.C. Williams Bakery Service, Inc)
FoodClass IReported February 11, 2026 · Undeclared Milk Allergen - Willy Pete's Chocolates brand Almond Despair recall (Willy Pete's Chocolate Company LLC)
FoodClass IIIReported February 11, 2026 · Almonds are not declared in the ingredient statement. Almond is included in description of product on front label. - BarbaCuban Havana Gold recall (Prima Foods International, Inc.)
FoodClass IIIReported February 11, 2026 · Undeclared Quinine - BarbaCuban Cubama White Truffle Sauce recall (Prima Foods International, Inc.)
FoodClass IIIReported February 11, 2026 · Undeclared Quinine - BarbaCuban Ram Air Red Zesty Ketchup recall (Prima Foods International, Inc.)
FoodClass IIIReported February 11, 2026 · Undeclared Quinine - BarbaCuban 455 Everything Sauce recall (Prima Foods International, Inc.)
FoodClass IIIReported February 11, 2026 · Undeclared Quinine - BarbaCuban 90 Miles to Mojo Marinade recall (Prima Foods International, Inc.)
FoodClass IIIReported February 11, 2026 · Undeclared Quinine - BarbaCuban 455 Everything Sauce recall (Prima Foods International, Inc.)
FoodClass IIIReported February 11, 2026 · Undeclared Quinine - Lost and Found Energy recall (Fazt & Loud LLC)
FoodClass IIIReported February 11, 2026 · Recall is due to a misprint on the label that incorrectly identifies the total caffeine content on the can. The item contains 300mg of caffeine, instead of... - Rheumacare capsules recall (HANDELNINE GLOBAL LLC)
DrugClass IReported February 11, 2026 · CGMP Deviations: product found to contain lead. - Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 ... recall (Fujirebio Diagnostics, Inc.)
Medical deviceClass IIReported February 11, 2026 · Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low... - Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number:... recall (Fujirebio Diagnostics, Inc.)
Medical deviceClass IIReported February 11, 2026 · Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low... - Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges ... recall (Fujirebio Diagnostics, Inc.)
Medical deviceClass IIReported February 11, 2026 · Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low... - Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 ... recall (Fujirebio Diagnostics, Inc.)
Medical deviceClass IIReported February 11, 2026 · Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low... - Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 ... recall (Fujirebio Diagnostics, Inc.)
Medical deviceClass IIReported February 11, 2026 · Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low... - Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog... recall (Fujirebio Diagnostics, Inc.)
Medical deviceClass IIReported February 11, 2026 · Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low... - Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number:... recall (Fujirebio Diagnostics, Inc.)
Medical deviceClass IIReported February 11, 2026 · Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low... - Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10 recall (Wilson-Cook Medical Inc.)
Medical deviceClass IIReported February 11, 2026 · Nasal feeding tube packaged without the nasal transfer tube component. - Vortex Surgical Lindsell Sutured IOL Marker recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Vortex Surgical 25GA Backflush recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Vortex Surgical TID Pharos Illuminated Depressor recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · XXX - Rumex Disposable Diamond Dusted ILM Elevator recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Vortex Surgical I2 Injection Kit recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Tecfen Retractable Membrane Polisher recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Vortex Surgical 25GA I.D.D. Internal Delivery Device recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA... recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - 25GA Subretinal Injection Cannula VS0220.25 recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 ... recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4... recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser... recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Focalyx Fusion recall (Focalyx Technologies, LLC.)
Medical deviceClass IIReported February 11, 2026 · Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function... - NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT... recall (Siemens Medical Solutions USA, Inc)
Medical deviceClass IIReported February 11, 2026 · To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. - NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT... recall (Siemens Medical Solutions USA, Inc)
Medical deviceClass IIReported February 11, 2026 · To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. - NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel... recall (Siemens Medical Solutions USA, Inc)
Medical deviceClass IIReported February 11, 2026 · To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. - SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT... recall (Siemens Medical Solutions USA, Inc)
Medical deviceClass IIReported February 11, 2026 · To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. - TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE recall (Tornier, Inc)
Medical deviceClass IIReported February 11, 2026 · A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery... - CellMek SPS Sample Preparation System recall (Beckman Coulter, Inc.)
Medical deviceClass IIReported February 11, 2026 · Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching... - *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm recall (Boston Scientific Corporation)
Medical deviceClass IReported February 11, 2026 · Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is... - *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm recall (Boston Scientific Corporation)
Medical deviceClass IReported February 11, 2026 · Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is... - HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm recall (Boston Scientific Corporation)
Medical deviceClass IReported February 11, 2026 · Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is... - AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm recall (Boston Scientific Corporation)
Medical deviceClass IReported February 11, 2026 · Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is... - AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm recall (Boston Scientific Corporation)
Medical deviceClass IReported February 11, 2026 · Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is...