Boston Scientific recalls

Boston Scientific has 626 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 9 Sep 2026. 399 are still ongoing. 64 were reported in the last 12 months.

Total recalls626since 2012

Last 12 months64reported

Class I11719% of total

Ongoing399latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

54Oct '24 7 2 3Jan '25 14 0 0Apr 4 0 4Jul 5 17 18Oct 0 0 1Jan '26 6 1 0Apr 4 1 23Jul 7 3

Severity split

Class I 117 19%Class II 503 80%Class III 6 1%

Why boston scientific is recalled

Product types

By year

2026467%
20256510%
202413021%
2023315%
2022498%
2021467%
20207913%
2019386%
2018559%
2017183%

Ongoing boston scientific recalls

399 active

Reported	Class	Recall	Company	Reason	Where
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

All boston scientific recalls, newest first

626 total

Reported	Class	Recall	Company	Reason	Where
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

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.