Westmed Neo-Vent Infant T-Piece Resuscitation Circuit Recall for Non-Compliant Connections
Westmed is recalling Neo-Vent Infant T-Piece Resuscitation Circuits because a mold repair resulted in non-compliant 15mm OD connections, preventing use with compatible infant resuscitators.
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: The recall is classified as FDA Class II, but the source text describes a functional incompatibility (non-compliant connections) rather than a direct safety hazard like injury or illness. This aligns with the rubric for moderate severity involving functional defects or low-risk issues where no harm is reported.
Plain-English summary
Westmed, Inc. is recalling 48 cases of Neo-Vent Infant T-Piece Resuscitation Circuits with Neonatal Masks (REF 0421). The affected units are intended for use on compatible Infant Resuscitators and were distributed worldwide, including nationwide in the United States and in Spain.
The recall was initiated because a repair to an adapter mold resulted in the production of parts with compliant 10mm ID connections but non-compliant 15mm OD connections. This manufacturing defect prevents facilities with infant resuscitators that connect via the 15mm OD fitting from using these circuits.
Affected lot codes include 101518U04, 102318U07, and 101618U03. Healthcare facilities and consumers should stop using these specific circuits and contact Westmed, Inc. for instructions on return or replacement.
The recalled product
- Product
- Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0421, Qty:10, Length: 60" (1.5cm), Rx Only.
- Manufacturer
- Westmed, Inc.
- Affected units
- 48
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 (3)
- 101518U04
- 102318U07
- 101618U03.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Westmed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Westmed, Inc.
See all →- HighWestmed Flex Extenders recalled for connector failure risk
FDA (Devices) · 2024-11-06
- HighWestmed Elongated Oxygen Mask Recalled for Loose Tube Connection
FDA (Devices) · 2021-01-06
- HighWestmed Non-Rebreather Masks Recalled for Loose Oxygen Tube Fitment
FDA (Devices) · 2021-01-06
- HighWestmed Adult Oxygen Mask Recall Due to Potential Loose Fitment
FDA (Devices) · 2021-01-06
- HighWestmed Adult Elongated CO2/O2 Mask Recall for Loose Fitment
FDA (Devices) · 2021-01-06
Same hazard · functional defect
See all →- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighAngiodynamics Soft-Vu Angiographic Catheter Guidewire Blockage Risk
FDA (Devices) · 2026-04-29
- SevereGE Healthcare CARESTATION anesthesia systems ventilation malfunction recall
FDA (Devices) · 2025-05-07