Medline Suction Liners Recalled Due to Potential Loss of Suction
Medline is recalling 1,616 units of semi-rigid suction liners (ENDO KIT, pack numbers DYKE1350D and DYKE1514B) manufactured September to November 2023 that may lose or provide reduced suction during use.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall issued due to reported adverse events related to potential loss of suction function. No specific injuries, hospitalizations, or illnesses are documented in the source material.
Plain-English summary
Medline Industries is recalling 1,616 units of semi-rigid suction liners marketed as ENDO KIT convenience kits (pack numbers DYKE1350D and DYKE1514B). The liners, which have a capacity of 1500 cc, were manufactured between September 2023 and November 2023 and may lose suction or provide reduced suction during intermittent suction use.
The affected products are identified by specific lot numbers. Pack Number DYKE1350D includes lot numbers 24CBG448 and 24EBF166. Pack Number DYKE1514B includes lot numbers 24CBR722 and 24FBA408.
These devices have been distributed worldwide, including the United States, Canada, and Panama. Healthcare facilities and medical professionals should immediately check for the specific pack and lot numbers listed above.
If you have any of these recalled items, discontinue use immediately and contact Medline Industries or the FDA for instructions on return, replacement, or disposal.
The recalled product
- Product
- Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D; b) ENDO KIT, Pack Number DYKE1514B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- loss-of-suction
- 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 (8)
- a) DYKE1350D: UDI/DI case 40193489339797
- UDI.DI each 10193489339796
- Lot Numbers: 24CBG448
- 24EBF166
- b) DYKE1514B: UDI/DI case 40193489797832
- UDI.DI each 10193489797831
- Lot Numbers: 24CBR722
- 24FBA408
Distribution
Distributed nationwide across the United States.
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