Medline Semi-Rigid Suction Liners Recalled for Potential Suction Loss
Medline is recalling 1,800 units of semi-rigid suction liners used in anesthesia turnover kits due to reported adverse events related to potential loss of suction during intermittent use. Affected lots were manufactured between September and November 2023.
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 device recall for a risk-of-harm medical product used in anesthesia. Suction failure during anesthesia poses significant patient risk. Although adverse events are reported, the source does not specify hospitalizations or detailed injuries, meeting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Medline Industries, LP is recalling 1,800 units of semi-rigid suction liners used in anesthesia turnover kits (ANES TURNOVER KIT-LF, Pack Number DYNJAA10338J) due to reported adverse events associated with potential loss of suction or low suction during intermittent suction use.
The affected liners are 1,500 cc capacity and were manufactured between September 2023 and November 2023. Affected lot numbers include 23LBO942, 24ABS046, and 24BBS971. The product has been distributed worldwide, including throughout the United States, Canada, and Panama.
Healthcare facilities and practitioners currently using these liners should discontinue use of the affected lots and contact Medline Industries for replacement units or further instructions. Patients or healthcare providers who have concerns about potential impact should consult with their healthcare provider.
The recalled product
- Product
- Medline convenience kits containing semi-rigid suction liners labeled as follows: ANES TURNOVER KIT-LF, Pack Number DYNJAA10338J
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- suction-loss
- device-malfunction
- aspiration-risk
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 (5)
- DYNJAA10338J: UDI/DI case 40195327489695
- UDI/DI each 10195327489694
- Lot Numbers: 23LBO942
- 24ABS046
- 24BBS971
Distribution
Distributed nationwide across the United States.
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