Abbott Medical recalls
Every recall we track for Abbott Medical — 43 in all, from 2019–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Abbott Medical fell by more than half in 2025 (3, down from 26 in 2024).
All FDA recall records for Abbott Medical since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 4 | 0 | 4 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 5 | 4 | 0 | 9 |
| 2024 | 0 | 0 | 26 | 0 | 26 |
| 2025 | 0 | 0 | 3 | 0 | 3 |
| 2026 (to date) | 0 | 0 | 1 | 0 | 1 |
What to do if you have a recalled Abbott Medical product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Abbott Medical recalls
16 shown- Lower riskMedical device
Abbott Medical recalls Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Abbott Medical recalls Merlin PCS 3650 programmer software versions 25.0.1-28.7.1 due to potential failure during pacemaker test. Affected units sold in US with GTIN 05414734509725.
Abbott MedicalMay 12, 2026 - Lower riskMedical device
Abbott Medical recalls Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Abbott Medical provides a wide range of medical devices and equipment for healthcare professionals. Our products are designed to improve patient outcomes and enhance clinical efficiency.
Abbott MedicalOct 6, 2025 - Lower riskMedical device
Abbott Medical recalls Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code:
Abbott Medical recalls Aveir DR leadless pacemakers with specific UDI-DI codes due to potential premature battery failure from higher than normal temperatures during manufacturing.
Abbott MedicalFeb 15, 2025 - Lower riskMedical device
Abbott Medical recalls The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming
Abbott Medical recalls Merlin PCS 3650 programmer model 3330 due to software anomaly that may cause leadless pacemaker programming failure with temporary loss of telemetry. Affected units have specific software versions and serial numbers listed in the recall notice.
Abbott MedicalNov 21, 2024 - Lower riskMedical device
Abbott Medical recalls Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
Abbott Medical recalls 27mm Navitor Transcatheter Aortic Heart Valves with possible durability concerns. Affected units have specific serial numbers and UDI-DI codes. Contact Abbott for details.
Abbott MedicalOct 17, 2024 - Lower riskMedical device
Abbott Medical recalls Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the
Abbott Medical recalls Merlin@home Transmitter EX1100 models with serial numbers listed. These devices may not update software after power interruptions during over-the-wire downloads, potentially causing monitoring issues.
Abbott MedicalOct 1, 2024 - Lower riskMedical device
Abbott Medical recalls Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
Abbott Medical recalls Infinity 7 implantable pulse generators with potential therapy loss due to incorrect end-of-service dates. Affected units have specific serial numbers.
Abbott MedicalMay 22, 2024 - Lower riskMedical device
Abbott Medical recalls Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Abbott Medical recalls Liberta RC implantable pulse generators with serial numbers 20196493-20240551. These devices may stop working every 50 days, causing loss of therapy.
Abbott MedicalMay 16, 2024 - Lower riskMedical device
Abbott Medical recalls Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
Abbott recalls Proclaim XR 5 implantable pulse generators with shorter-than-labeled replacement warning. Affected units may need earlier replacement to prevent complications.
Abbott MedicalMay 16, 2024 - Lower riskMedical device
Abbott Medical recalls Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
Abbott Medical provides a wide range of medical devices and equipment for healthcare professionals. Our products are designed to improve patient outcomes and enhance clinical efficiency.
Abbott MedicalFeb 5, 2024 - Lower riskMedical device
Abbott Medical recalls Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter
Abbott Medical - 111016731
AbbottAug 16, 2023 - Lower riskMedical device
Abbott Medical recalls Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an
Abbott Medical recalls Proclaim Plus 5 Implantable Pulse Generators (REF 3670) due to patients being unable to exit MRI (Magnetic Resonance Imaging) mode. This device is used for spinal cord stimulation and may require specific MRI safety checks.
Abbott MedicalJul 18, 2023 - Lower riskMedical device
Abbott Medical recalls Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath
Abbott Medical recalls Fast-Cath Hemostasis Introducers with 8F instead of 8.5F dilators. These devices may cause improper vessel access during procedures. Affected batches include 6917183, 6950628, and 7099144.
Abbott MedicalDec 9, 2019 - Lower riskMedical device
Abbott Medical recalls Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Abbott Medical recalls Fast-Cath Trio Hemostasis Introducers with 12F instead of 14F devices. This mismatch may cause improper use during medical procedures.
Abbott MedicalDec 9, 2019 - Lower riskMedical device
Abbott Medical recalls CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable
Abbott Medical recalls a specific lot of Classic Radiofrequency Cannulas due to incorrect tip length labeling, which may lead to improper lesion size during medical procedures.
Abbott MedicalNov 11, 2019 - Lower riskMedical device
Abbott Medical recalls Radiofrequency Grounding Pad, REF RF-DGP-L
Abbott Medical recalls Radiofrequency Grounding Pads with incorrect release liner orientation that may cause uneven heating during use. Affected units have specific batch numbers and UDI codes.
Abbott MedicalOct 14, 2019
Abbott Medical recall questions
How many recalls has Abbott Medical had?
43 recalls from Abbott Medical are on record with U.S. safety agencies, from 2019–2026.
What is the most recent Abbott Medical recall?
Abbott Medical recalls Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software, dated May 12, 2026. Every Abbott Medical recall is listed on this page, newest first.
What should I do if I have a recalled Abbott Medical product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Abbott Medical recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.