Pacemakers & Defibrillators recalls

494 medical device recalls in the pacemakers & defibrillators category are on file with the FDA, from 2012 to 16 Sep 2026. The leading reason is device malfunction.

Total recalls494since 2012

Last 12 months21reported

Class I13427% of total

Ongoing254latest 16 Sep 2026

Recalls per month, last 24 months

click a bar for that month

7Nov '24 2 1 1Feb 4 6 5May 0 0 3Aug 2 7 2Nov 0 0 2Feb 1 2 2May 3 1 0Aug 1 0

Severity split

Class I 134 27%Class II 355 72%Class III 5 1%

Why pacemakers & defibrillators is recalled

Companies

Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf)11824%
Boston Scientific6814%
Philips Electronics North America357%
Philips Medical Systems275%
Philips North America255%
Medtronic245%
Physio-Control214%
Medline Industries LP - Northfield194%

By year

2026122%
2025316%
20245311%
20239419%
2022204%
2021255%
2020214%
2019224%
20187215%
2017367%

Ongoing pacemakers & defibrillators recalls

254 active

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	DermaV Laser System recalled by Lutronic	Lutronic	Other	Nationwide
1 Jul 2026Device	CLASS II	Convenience kits containing select SKUs of Polycarbonate recalled	Medline Industries	Other	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Loop Pack DYNJ61460C Open Heart recalled	Medline Industries	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Acl Pack DYNJ64161C Arthroscopy recalled	Medline Industries	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled	Medline Industries	Device Malfunction	Nationwide
6 May 2026Device	CLASS I	Pacemaker, Implantable Pulse Generator, Pacemaker recalled	Boston Scientific	Device Malfunction	MN

All pacemakers & defibrillators recalls, newest first

494 total

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	DermaV Laser System recalled by Lutronic	Lutronic	Other	Nationwide
1 Jul 2026Device	CLASS II	Convenience kits containing select SKUs of Polycarbonate recalled	Medline Industries	Other	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Loop Pack DYNJ61460C Open Heart recalled	Medline Industries	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Acl Pack DYNJ64161C Arthroscopy recalled	Medline Industries	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled	Medline Industries	Device Malfunction	Nationwide
6 May 2026Device	CLASS I	Pacemaker, Implantable Pulse Generator, Pacemaker recalled	Boston Scientific	Device Malfunction	MN
6 May 2026Device	CLASS I	Cardiac Resynchronization Therapy (Crt)labeled as: Valitude Crt-p EL recalled	Boston Scientific	Device Malfunction	MN
29 Apr 2026Device	CLASS II	Medline Kits: Newborn Admission recalled by Medline Industries	Medline Industries	Other	Nationwide
29 Apr 2026Device	CLASS II	Medline Convenience Kits containing select SKUs recalled	Medline Industries	Device Malfunction	Nationwide
18 Mar 2026Device	CLASS II	Physio Control Infant/Child Reduced Energy Defibrillator Electrodes recalled	Physio-Control	Other	Nationwide
4 Feb 2026Device	CLASS II	Medline medical procedure convenience kits labeled as recalled	Medline Industries	Device Malfunction	Nationwide
4 Feb 2026Device	CLASS II	Medline medical procedure convenience kits labeled as recalled	Medline Industries	Device Malfunction	Nationwide
26 Nov 2025Device	CLASS II	Medline convenience kits labeled as: General Aaa #11-RF recalled	Medline Industries	Other	Nationwide
26 Nov 2025Device	CLASS II	Medline convenience kits labeled as: Cath Lab Pacemaker Pack recalled	Medline Industries	Other	Nationwide
22 Oct 2025Device	CLASS I	Model Number S722, Altrua 2 DR EL Pacemaker recalled	Boston Scientific	Device Malfunction	MN
22 Oct 2025Device	CLASS I	Model Number L100, Essentio SR SL Pacemaker recalled	Boston Scientific	Device Malfunction	MN
22 Oct 2025Device	CLASS II	Medical convenience kits recalled by American Contract Systems	American Contract Systems	Sterility	Nationwide
22 Oct 2025Device	CLASS I	Model Number S701 Altrua 2 SR SL Pacemaker recalled by Boston Scientific	Boston Scientific	Device Malfunction	MN
22 Oct 2025Device	CLASS I	Model Number L221 Proponent DR EL Pacemaker recalled	Boston Scientific	Device Malfunction	MN
22 Oct 2025Device	CLASS I	Model Number L209 Proponent DR (VDD) SL Pacemaker recalled	Boston Scientific	Device Malfunction	MN
22 Oct 2025Device	CLASS I	Model Number S702, Altrua 2 DR SL Pacemaker recalled	Boston Scientific	Device Malfunction	MN
10 Sep 2025Device	CLASS II	Lifepak 1000 Part recalled by Physio-Control	Physio-Control	Processing Deviation	Nationwide
10 Sep 2025Device	CLASS II	Lifepak CR2 Part recalled by Physio-Control	Physio-Control	Processing Deviation	Nationwide
27 Aug 2025Device	CLASS I	Endotak Reliance G/SG, transvenous defibrillation lead recalled	Boston Scientific	Other	Nationwide
27 Aug 2025Device	CLASS I	Reliance 4-Front, endocardial cardioversion/defibrillation recalled	Boston Scientific	Other	Nationwide
27 Aug 2025Device	CLASS I	Endotak Reliance G/SG with 4-Site Connector recalled	Boston Scientific	Other	Nationwide
7 May 2025Device	CLASS II	Automated External Defibrillators recalled by Defibtech	Defibtech	Other	CT
7 May 2025Device	CLASS II	Automated External Defibrillators recalled by Defibtech	Defibtech	Other	CT
7 May 2025Device	CLASS II	Automated External Defibrillators recalled by Defibtech	Defibtech	Other	CT
7 May 2025Device	CLASS II	Automated External Defibrillators recalled by Defibtech	Defibtech	Other	CT

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.