Boston Scientific Corporation: 296 recalls on record

Recalls filed with 1 agency: FDA (296).

First recall on record: June 27, 2012. Most recent: September 23, 2026.

Risk classification: Class I: 73 · Class II: 221 · Class III: 2

Most recent recalls

DateAgencyProduct
December 30, 2020FDAIceSphere" 1.5 CX 90¿ Cryoablation NeedleZ-0664-2021
December 30, 2020FDAIceSphere" 1.5 Cryoablation NeedleZ-0674-2021
December 30, 2020FDAIceSeed" 1.5 Cryoablation NeedleZ-0676-2021
December 30, 2020FDAFive IceSphere" Prostate Cryoablation KitZ-0689-2021
December 30, 2020FDAIceSeed" 1.5 MRI Cryoablation NeedleZ-0681-2021
December 30, 2020FDAIceRod" 1.5 CX 90¿ Cryoablation Needle¿Z-0663-2021
December 30, 2020FDAIceSeed" 1.5 90¿ Cryoablation NeedleZ-0675-2021
December 30, 2020FDAIceSphere" 1.5 S 90¿ Cryoablation NeedleZ-0672-2021
December 30, 2020FDAIcePearl" 2.1 CX Cryoablation NeedleZ-0661-2021
December 30, 2020FDAIcePearl" 2.1 CX 90¿ Cryoablation NeedleZ-0660-2021
December 30, 2020FDAIceRod" 1.5 i-Thaw" Cryoablation NeedleZ-0665-2021
December 23, 2020FDAEKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) S…Z-0637-2021
November 18, 2020FDAAMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connec…Z-0427-2021
August 12, 2020FDACaptivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire ca…Z-2761-2020
August 12, 2020FDACaptivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire ca…Z-2765-2020
July 29, 2020FDAAblation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Prescription O…Z-2679-2020
July 29, 2020FDAAblation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE Sy…Z-2680-2020
July 29, 2020FDAAblation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only …Z-2676-2020
May 6, 2020FDAMoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for th…Z-1798-2020
April 1, 2020FDAImager II 5F Angiographic Catheters, 5 units per package.Z-1555-2020
December 4, 2019FDABoston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M0053…Z-0557-2020
December 4, 2019FDABoston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm UPN: M005…Z-0558-2020
December 4, 2019FDABoston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN: M0053…Z-0550-2020
December 4, 2019FDABoston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm UPN: M0053…Z-0560-2020
December 4, 2019FDABoston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M005…Z-0548-2020

Questions about this company

How many recalls does Boston Scientific Corporation have?
Recalert has 296 U.S. recalls on record for Boston Scientific Corporation, published between June 27, 2012 and September 23, 2026.
Which agencies have handled Boston Scientific Corporation recalls?
Boston Scientific Corporation appears as the recalling firm in recalls from: FDA (296).

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