GE Healthcare Recalls D-Fend Water Traps Due to Occlusion Risk
GE Healthcare is recalling D-Fend and D-Fend+ water traps because they may occlude, causing a loss of respiratory gas monitoring.
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 involves a risk-of-harm product (loss of monitoring) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
GE Healthcare is recalling specific D-Fend and D-Fend+ water traps used with Compact Airway Modules and Cardiocap/5 monitors. The recall involves 5,018 units distributed worldwide, including the United States and numerous international locations.
The recall is due to a potential safety issue where the water traps may occlude. This occlusion can cause a loss of respiratory airway gas monitoring, which is intended to protect the monitor from humidity, secretions, and bacterial contamination while monitoring patient respiration and ventilation.
Healthcare facilities should identify the affected units by checking the product numbers (876446-HEL and 881319-HEL) and specific lot numbers listed in the recall notice. Affected units should be removed from service and returned to GE Healthcare for evaluation or replacement.
The recalled product
- Product
- D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. Product Usage: Water traps are intended to protect the GE monitor from humidity, secretions and bacterial contamination when…
- Manufacturer
- GE Healthcare
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 (9)
- p/n 876446-HEL Lot numbers: J9964985
- J10201698
- J10258248
- J10284871
- J10284872
- J10344108. p/n 881319-HEL Lot numbers: J9906966
- J9965152
- J10258251
- J10300071.
Distribution
Related recalls
Same manufacturer · GE Healthcare
See all →- HighGE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Association Errors
FDA (Devices) · 2026-09-23
- HighGE Healthcare Recalls Centricity PACS Server V7 Due to Data Association Error
FDA (Devices) · 2026-09-23
- HighGE Healthcare Recalls Centricity PACS Software Due to Data Association Errors
FDA (Devices) · 2026-09-23
- HighGE Healthcare Recalls Core Services Hub V8 Due to Data Association Errors
FDA (Devices) · 2026-09-23
- HighGE Healthcare Recalls Workflow Core Services V8 Due to Data Association Errors
FDA (Devices) · 2026-09-23
Same hazard · loss of monitoring
See all →- HighGE Medical Systems Recalls Portrait Core Services Software Due to Monitoring Loss
FDA (Devices) · 2026-09-02
- HighGE Medical Systems Recalls Portrait Compute and Core Services Software
FDA (Devices) · 2026-09-02
- HighGE Medical Systems Recalls Portrait Core Services Software Due to Monitoring Loss
FDA (Devices) · 2026-09-02
- HighGE Medical Systems Recalls Portrait Core Services Software Reload Unit
FDA (Devices) · 2026-09-02
- HighGE Healthcare Portrait Core Services Software Recall Due to Software Vulnerability
FDA (Devices) · 2026-08-12
Similar recalls
- HighGE Healthcare Compact Airway Modules Recalled for Pump Failure Risk
FDA (Devices) · 2014-06-25
- SevereDraeger Medical Recalls ID Circuit Watertrap Breathing Circuits Due to Assembly Error
FDA (Devices) · 2019-01-30
- HighGE Healthcare Recalls Dash Patient Monitors Due to ECG Noise
FDA (Devices) · 2014-01-29
- HighGE Healthcare Recalls TRAM Modules Due to Intermittent ECG Noise
FDA (Devices) · 2014-01-29
- HighGE Healthcare Recalls Dash Patient Monitors Due to Signal Noise
FDA (Devices) · 2013-09-04
- HighGE Healthcare Recalls X-ray Systems Due to Monitor Suspension Nut Issue
FDA (Devices) · 2014-02-12