Halyard KimVent Closed Suction System Thumb Valve Recall
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, even when it appears locked.
What this means for you
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 defect presents a risk of harm to patients using the medical device, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Halyard Health, Inc. is recalling specific lots of KimVent Closed Suction Systems for adults. The affected products include 12 F and 14 F sizes with DSE specifications, identified by product codes 2210, 21603, 22103, and 22714183. These devices are tracheobronchial suction catheters attached to an airway circuit to aspirate liquids or semisolids from a patient's upper airway.
The recall was initiated because the thumb valve on some units remained partially open after suctioning was completed, despite the valve appearing to be closed or in the "LOCKED" position. This defect could compromise the closed system's integrity during use.
The affected products were distributed worldwide, including nationwide in the United States, Puerto Rico, and internationally to Canada. Specific lot numbers affected include M5054T630, M5082T625, M5089T611, M5117T627, M5089T618, M5103T610, M5089T617, and M5082T318. Healthcare facilities and users should stop using the affected units and contact Halyard Health for instructions on replacement or return.
The recalled product
- Product
- KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 2210); KimVent* Closed Suction System for Adults, 12 F, DSE (Product 21603); KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 22103); KimVent* Closed Suction System for Adults, 14 F, DSE (Product
- Manufacturer
- Halyard Health, Inc
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 (8)
- Product Code 2210 - M5054T630
- M5082T625
- M5089T611
- M5117T627
- Product Code 21603 - M5089T618
- M5103T610
- Product Code 22103 - M5089T617
- Product Code 22714183 M5082T318
Distribution
Part of a larger recall action
This product is one of 32 recalled by Halyard Health, 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 32 products in this recall →Related recalls
Same manufacturer · Halyard Health, Inc
See all →- HighHalyard Closed Suction System Recall Due to Loose Flex Connectors
FDA (Devices) · 2018-04-25
- HighHalyard Closed Suction System Flex Connectors May Disconnect During Use
FDA (Devices) · 2018-04-25
- HighHalyard Closed Suction System Flex Connectors May Disconnect During Use
FDA (Devices) · 2018-04-25
- ModerateHalyard Health Recalls CORTRAK 2 Nasogastric Feeding Tubes
FDA (Devices) · 2018-04-11
- HighHalyard Closed Suction System Saline Vials Recalled for Potential Leaking
FDA (Devices) · 2017-11-29
Same hazard · device malfunction
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- SevereGEM Premier 5000 PAK Lysing Solution Concentration Recall
FDA (Devices) · 2026-08-12
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12