Boston Scientific recalls

Boston Scientific has 628 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 30 Sep 2026. 401 are still ongoing. 65 were reported in the last 12 months.

Total recalls628since 2012

Last 12 months65reported

Class I11819% of total

Ongoing401latest 30 Sep 2026

Recalls per month, last 24 months

click a bar for that month

7Nov '24 2 3 14Feb 0 0 4May 0 4 5Aug 17 18 0Nov 0 1 6Feb 1 0 4May 1 23 7Aug 5 0

Severity split

Class I 118 19%Class II 504 80%Class III 6 1%

Why boston scientific is recalled

Product types

By year

2026488%
20256510%
202413021%
2023315%
2022498%
2021467%
20207913%
2019386%
2018559%
2017183%

Ongoing boston scientific recalls

401 active

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS I	Imager II Angiographic Catheters M001314001 Imager recalled	Boston Scientific	Other	Nationwide
23 Sep 2026Device	CLASS II	StoneSmart Connect Console Contents: Power Cord recalled	Boston Scientific	Other	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
26 Aug 2026Device	CLASS I	Enroute Transcarotid Neuroprotection System recalled	Boston Scientific	Other	Nationwide

All boston scientific recalls, newest first

628 total

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS I	Imager II Angiographic Catheters M001314001 Imager recalled	Boston Scientific	Other	Nationwide
23 Sep 2026Device	CLASS II	StoneSmart Connect Console Contents: Power Cord recalled	Boston Scientific	Other	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
26 Aug 2026Device	CLASS I	Enroute Transcarotid Neuroprotection System recalled	Boston Scientific	Other	Nationwide
26 Aug 2026Device	CLASS I	Enroute Transcarotid Neuroprotection System Plus recalled	Boston Scientific	Other	Nationwide
26 Aug 2026Device	CLASS II	Suture Cinch Long Endoscopic tissue approximation device recalled	Boston Scientific	Device Malfunction	Nationwide
26 Aug 2026Device	CLASS II	OverStitch Suture Cinch Endoscopic tissue approximation device recalled	Boston Scientific	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	Radial Jaw 4 Standard Capacity Biopsy Forceps recalled	Boston Scientific	Sterility	Nationwide
12 Aug 2026Device	CLASS II	Radial Jaw 4 Large Capacity Biopsy Forceps recalled by Boston Scientific	Boston Scientific	Sterility	Nationwide
12 Aug 2026Device	CLASS II	Radial Jaw 4 Jumbo Biopsy Forceps recalled by Boston Scientific	Boston Scientific	Sterility	Nationwide
29 Jul 2026Device	CLASS II	Faradrive Steerable Sheath (Clear) - US recalled by Boston Scientific	Boston Scientific	Other	Nationwide
29 Jul 2026Device	CLASS II	Faradrive Steerable Sheath Clear IDE recalled by Boston Scientific	Boston Scientific	Other	Nationwide
29 Jul 2026Device	CLASS II	Faradrive Steerable Sheath Clear Ous recalled by Boston Scientific	Boston Scientific	Other	Nationwide
29 Jul 2026Device	CLASS II	TheraSphere 360 Y-90 Management Platform recalled by Boston Scientific	Boston Scientific	Device Malfunction	Nationwide
29 Jul 2026Device	CLASS II	Farastar PFA Generator, Product ID M004PFCE61M460 recalled	Boston Scientific	Other	MN
29 Jul 2026Device	CLASS II	Farastar Pulsed Field Ablation Generator, Product ID M004PFCE61M401 recalled	Boston Scientific	Other	MN
29 Jul 2026Device	CLASS II	Farastar Ablation Generator EU recalled by Boston Scientific	Boston Scientific	Other	MN
29 Jul 2026Device	CLASS II	Farastar Ablation Generator EU recalled by Boston Scientific	Boston Scientific	Other	MN
29 Jul 2026Device	CLASS II	Faradrive Steerable Sheath Clear recalled by Boston Scientific	Boston Scientific	Other	Nationwide
22 Jul 2026Device	CLASS II	Rapid Refill Continuous Injection System, UPN M00566001 recalled	Boston Scientific	Packaging Defects	Nationwide
8 Jul 2026Device	CLASS II	CRE Pro Wireguided recalled by Boston Scientific	Boston Scientific	Sterility	Nationwide
8 Jul 2026Device	CLASS II	CRE Wireguided recalled by Boston Scientific	Boston Scientific	Sterility	Nationwide
8 Jul 2026Device	CLASS II	CRE Pro Wireguided recalled by Boston Scientific	Boston Scientific	Sterility	Nationwide
8 Jul 2026Device	CLASS II	CRE Wireguided recalled by Boston Scientific	Boston Scientific	Sterility	Nationwide
8 Jul 2026Device	CLASS II	CRE Wireguided recalled by Boston Scientific	Boston Scientific	Sterility	Nationwide
8 Jul 2026Device	CLASS II	CRE Wireguided recalled by Boston Scientific	Boston Scientific	Sterility	Nationwide
8 Jul 2026Device	CLASS II	CRE Wireguided recalled by Boston Scientific	Boston Scientific	Sterility	Nationwide
8 Jul 2026Device	CLASS II	CRE Wireguided recalled by Boston Scientific	Boston Scientific	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.