Agency classClass IIOur severity:High FDA (Devices)·Z-0916-2014·Announced 2014-02-12

GE Healthcare Recalls Stand-Alone Resuscitation T-Pieces Due to Loose Knob

GE Healthcare is recalling 375 Stand-Alone Resuscitation T-Pieces because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (inaccurate gas mixture) to patients, but no injuries or illnesses have been reported in the source text.

Plain-English summary

GE Healthcare is recalling 375 units of Stand-Alone Resuscitation T-Pieces. The recall involves specific part numbers and serial numbers, including those beginning with QABR and QABS. These devices are used to provide the basic equipment required for pulmonary resuscitation of infants.

The recall was initiated because the medical device adjustment knob may be loose. This defect may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.

The affected units were distributed worldwide, including the United States (nationwide), Puerto Rico, and numerous international countries. Consumers and healthcare facilities should check their inventory for the specific serial numbers and part numbers listed in the official recall notice. If a unit is affected, it should be removed from service and returned to GE Healthcare for inspection or replacement.

The recalled product

Product: Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001, M1226442, M1241420, M1241421, M1241424, M1241425, M1241427, M1241430, M1241461, M1241463, M1241464, and M1241589; labeled in part ***GE Healthcare 8880 Gorman Road…
Manufacturer: GE Healthcare
Category: Medical Device — Resuscitation Equipment
Hazard: inaccurate-gas-mixture
loose-component
Affected units: 375

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 recalled by GE Healthcare 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 6 products in this recall →

Same manufacturer · GE Healthcare

See all →

High
GE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Association Errors
FDA (Devices) · 2026-09-23
High
GE Healthcare Recalls Centricity PACS Server V7 Due to Data Association Error
FDA (Devices) · 2026-09-23
High
GE Healthcare Recalls Centricity PACS Software Due to Data Association Errors
FDA (Devices) · 2026-09-23
High
GE Healthcare Recalls Core Services Hub V8 Due to Data Association Errors
FDA (Devices) · 2026-09-23
High
GE Healthcare Recalls Workflow Core Services V8 Due to Data Association Errors
FDA (Devices) · 2026-09-23

Same hazard · inaccurate gas mixture