Medline Suction Liners Recalled Due to Potential Suction Loss
Medline Industries is recalling 134 units of semi-rigid suction liners due to potential loss of suction during intermittent use. The affected kits were distributed worldwide including the US, Canada, and Panama.
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: This is an FDA Class II medical device recall initiated in response to reported adverse events. The affected suction liners are functional equipment used in clinical drainage applications, and potential suction loss could impact patient care. However, no specific hospitalizations or serious injuries are documented in the recall notice, keeping the severity at High rather than Severe.
Plain-English summary
Medline Industries, LP is recalling specific lots of semi-rigid suction liners contained in convenience kits labeled as KIT NEURO SHUNT ST LOUIS CHILD, Pack Number DYNJ907829B. The recall was initiated due to reported adverse events related to potential loss of suction or low suction during intermittent suction use.
The recall affects 134 units with lot numbers 23LMA774, 23LME672, 24AMA991, 24CMB554, and 24CMB648. These products were manufactured between September 2023 and November 2023 and have been distributed in the United States, Canada, and Panama.
Healthcare facilities and medical professionals with these kits should discontinue use of the affected lot numbers and contact Medline Industries for replacement or disposal instructions. The recall indicates that the suction liners may not maintain adequate suction during clinical use, which could impact patient care.
The recalled product
- Product
- Medline convenience kits containing semi-rigid suction liners labeled as follows: KIT NEURO SHUNT ST LOUIS CHILD, Pack Number DYNJ907829B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- suction-loss
- device-malfunction
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 (7)
- DYNJ907829B: UDI/DI case 40195327077991
- UDI/DI each 10195327077990
- Lot Numbers: 23LMA774
- 23LME672
- 24AMA991
- 24CMB554
- 24CMB648
Distribution
Distributed nationwide across the United States.
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