Abbott Medical recalls The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates…
Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the…
Read the official notice →- Date
- 2025-01-01
- Country
- United States
- Brand
- Abbott Medical
- Product
- The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution including in the states of AL, AR,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Abbott Medical recalls
- 2026-06-17
USAbbott Medical recalls Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
FDA · DeviceAbbott MedicalUS Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice →- 2025-11-19
- US
Abbott Medical recalls Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 .…
- 2025-04-23
- US
Abbott Medical recalls Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The…
Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
FDA · DeviceAbbott MedicalWorldwide - U.S. Nationwide distribution in the states of FL, SC, and WV and…Official notice → - 2024-12-04
- US
Abbott Medical recalls Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted…
Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
FDA · DeviceAbbott MedicalWorldwide - U.S. Nationwide distribution in the states of ALABAMA, ALASKA,…Official notice → - 2024-11-27
- US
Abbott Medical recalls Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or…
FDA · DeviceAbbott MedicalNew York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman,…Official notice → - 2024-07-31
- US
Abbott Medical recalls Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
FDA · DeviceAbbott MedicalWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →
Other drugs & medical recalls in the United States
- 2025-01-01
- US
Moximed, Inc. recalls MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Knee implant may fracture due to a supplier-related issue with one component that has nonconforming geometry at the distal end of the absorber component that may result in a reduced wall thickness and microcracks,…
FDA · DeviceMoximed, Inc.US Nationwide distribution in the states of CA, OR, NY, OH, TX, CO, NY, VA.Official notice → - US
Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
FDA · DeviceEncore Medical, LPUS Nationwide distribution in the states of IN, KS, CA, FL, NY, TX, AL, WA.Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
- US
SEASPINE ORTHOPEDICS CORPORATION recalls Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002…
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONU.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.Official notice → - US
Straight Smile, LLC recalls BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically…
Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindications.
FDA · DeviceStraight Smile, LLCWorldwide - U.S. Nationwide distribution including in the states of CO, KS,…Official notice → - US
Becton, Dickinson and Company, BD Bio Sciences recalls FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended…
On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric…
FDA · DeviceBecton, Dickinson and Company, BD Bio SciencesWorldwide - US Nationwide distribution including in the states of Alabama,…Official notice →