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
April 3, 2024FDABoston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral…Z-1390-2024
April 3, 2024FDABoston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050Z-1302-2024
April 3, 2024FDAObsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010Z-1374-2024
February 28, 2024FDAEndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.Z-1153-2024
January 17, 2024FDABoston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed wi…Z-0673-2024
November 29, 2023FDAEXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242…Z-0396-2024
October 11, 2023FDAGuider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac gu…Z-0015-2024
August 30, 2023FDAEMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrilla…Z-2441-2023
May 24, 2023FDAWATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inne…Z-1592-2023
November 9, 2022FDAEMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.Z-0151-2023
May 4, 2022FDASpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily positio…Z-1002-2022
May 4, 2022FDASpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior …Z-1003-2022
April 20, 2022FDAROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive FloppyZ-0915-2022
March 23, 2022FDAHYDRATOME RX 49-20MM/260CM Material Number: M00583000Z-0763-2022
March 23, 2022FDAHYDRATOME RX 44-20MM/450CM Material Number: M00583060Z-0760-2022
March 23, 2022FDAJAGTOME RX 39-30-260-025 Material Number: M00573100Z-0770-2022
March 23, 2022FDAJAGTOME RX 44-20-260-035 Material Number: M00573040Z-0773-2022
March 23, 2022FDADREAMTOME 44-30MM/260CM Material Number: M00584050Z-0753-2022
March 23, 2022FDAJAGTOME RX 39-20-450-025 Material Number: M00573090Z-0769-2022
December 8, 2021FDAHURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the …Z-0323-2022
July 14, 2021FDAAccolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331Z-2000-2021
January 27, 2021FDAEMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter de…Z-0879-2021
January 20, 2021FDALotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery Sys…Z-0728-2021
January 13, 2021FDAHot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M0055…Z-0778-2021
January 13, 2021FDAAXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Pro…Z-0775-2021

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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