Baxter ELI 380 Electrocardiograph Recalled After Misdirected Shipment
Baxter recalls one ELI 380 electrocardiograph that was shipped to a customer in Texas by mistake on 26 October 2022. The device was intended for a pilot program only.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II FDA recall for a misdirected shipment with no reported injuries, illnesses, or described safety hazards. The concern is administrative—the device reaching an unintended customer—rather than a product defect, making this a moderate-level voluntary precautionary recall.
Plain-English summary
Baxter Healthcare Corporation is recalling one model ELI 380 electrocardiograph that was misdirected and shipped to a customer in Texas on 26 October 2022. The device carries lot number 122420001706 and was intended to be used only for a pilot program.
The device should not have been distributed to the customer who received it. This is a Class II FDA recall. Persons who received this ELI 380 unit should contact Baxter Healthcare Corporation.
The recalled product
- Product
- Baxter Electrocardiograph, ELI 380 -DCS21
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- unauthorized-distribution
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number 122420001706
Distribution
Distributed in 1 state:
- TX
Related recalls
Same category
- HighMedtronic DLP One-Piece Pediatric Arterial Cannula Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22