Abbott recalls

Abbott has 20 recalls on record with the FDA and USDA, the earliest in 2019 and the latest reported on 22 Oct 2025. 11 are still ongoing.

Total recalls20since 2019

Last 12 months0reported

Class I630% of total

Ongoing11latest 22 Oct 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 2 0May 0 0 0Aug 0 5 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 6 30%Class II 14 70%Class III 0 0%

Why abbott is recalled

Product types

By year

2025735%
2024210%
2023210%
2022630%
2020210%
201915%

Ongoing abbott recalls

11 active

Reported	Class	Recall	Company	Reason	Where
22 Oct 2025Device	CLASS I	TactiFlex Sensor Enabled Ablation Catheter, 8F, DF, (BiD Curve D-F) recalled	Abbott	Packaging Defects	MN
22 Oct 2025Device	CLASS I	TactiFlex Sensor Enabled Ablation Catheter, 8F, F, (UniD Curve F) recalled	Abbott	Packaging Defects	MN
22 Oct 2025Device	CLASS I	TactiFlex Sensor Enabled Ablation Catheter, 8F, D, (UniD Curve D) recalled	Abbott	Packaging Defects	MN
22 Oct 2025Device	CLASS I	TactiFlex Sensor Enabled Ablation Catheter, 8F, DD, (BiD Curve D-D) recalled	Abbott	Packaging Defects	MN
22 Oct 2025Device	CLASS I	TactiFlex Sensor Enabled Ablation Catheter, 8F, FJ, (BiD Curve F-J) recalled	Abbott	Packaging Defects	MN
30 Apr 2025Device	CLASS II	Amplatzer TorqVue LP Catheter (Tvlpc) recalled by Abbott	Abbott	Other	Nationwide

All abbott recalls, newest first

20 total

Reported	Class	Recall	Company	Reason	Where
22 Oct 2025Device	CLASS I	TactiFlex Sensor Enabled Ablation Catheter, 8F, DF, (BiD Curve D-F) recalled	Abbott	Packaging Defects	MN
22 Oct 2025Device	CLASS I	TactiFlex Sensor Enabled Ablation Catheter, 8F, F, (UniD Curve F) recalled	Abbott	Packaging Defects	MN
22 Oct 2025Device	CLASS I	TactiFlex Sensor Enabled Ablation Catheter, 8F, D, (UniD Curve D) recalled	Abbott	Packaging Defects	MN
22 Oct 2025Device	CLASS I	TactiFlex Sensor Enabled Ablation Catheter, 8F, DD, (BiD Curve D-D) recalled	Abbott	Packaging Defects	MN
22 Oct 2025Device	CLASS I	TactiFlex Sensor Enabled Ablation Catheter, 8F, FJ, (BiD Curve F-J) recalled	Abbott	Packaging Defects	MN
30 Apr 2025Device	CLASS II	Amplatzer TorqVue LP Catheter (Tvlpc) recalled by Abbott	Abbott	Other	Nationwide
30 Apr 2025Device	CLASS II	Amplatzer TorqVue LP Delivery System (TVLP) recalled by Abbott	Abbott	Other	Nationwide
10 Apr 2024Device	CLASS II	Alinity i Anti-HCV Reagent Kit, List Number 08P0521 recalled by Abbott	Abbott	Other	Nationwide
10 Apr 2024Device	CLASS II	Architect Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79 recalled	Abbott	Other	Nationwide
8 Nov 2023Device	CLASS II	NT2000iX Radiofrequency (RF) generator recalled by Abbott	Abbott	Device Malfunction	MN
19 Jul 2023Device	CLASS I	Amplatzer Steerable Delivery Sheath (ASDS) recalled by Abbott	Abbott	Other	Nationwide
13 Jul 2022Device	CLASS II	TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F FJ recalled	Abbott	Device Malfunction	Nationwide
8 Jun 2022Device	CLASS II	FIRMap" Catheter Basket recalled by Abbott	Abbott	Packaging Defects	Nationwide
27 Apr 2022Device	CLASS II	SE TactiCath Sensor Enabled Contact Force Ablation Catheter recalled	Abbott	Device Malfunction	Nationwide
27 Apr 2022Device	CLASS II	SE TactiCath Sensor Enabled Contact Force Ablation Catheter recalled	Abbott	Device Malfunction	Nationwide
13 Apr 2022Device	CLASS II	Amplatzer Steerable Delivery Sheath recalled by Abbott	Abbott	Other	MN
5 Jan 2022Device	CLASS II	Ultimum Hemostasis Introducer 5f recalled by Abbott	Abbott	Other	Nationwide
15 Jul 2020Device	CLASS II	TactiCath Quartz Contact Force Ablation Catheter recalled by Abbott	Abbott	Other	MN
22 Apr 2020Device	CLASS II	Merlin PCS recalled by Abbott	Abbott	Device Malfunction	39 states
1 May 2019Device	CLASS II	St. Jude Medical Confirm Rx Insertable Cardiac Monitor recalled	Abbott	Other	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.