Medline semi-rigid suction liners recalled for potential suction loss
Medline is recalling specific lots of semi-rigid suction liners from surgical convenience kits due to potential loss of suction during intermittent use. The recall affects approximately 3117 units distributed in 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: FDA Class II recall with reported adverse events involving functional failure (loss of suction) in surgical equipment. No specific injuries or hospitalizations are detailed in the source, making this a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling specific lots of semi-rigid suction liners used in surgical convenience kits. Affected kits include ENDO KIT, VIDEO BRONCHOSCOPY TRAY, SUCTION CANISTER KIT, and other surgical packs, with manufacturing dates from September 2023 to November 2023. Approximately 3117 units are involved in this recall.
The recall was triggered by reported adverse events involving potential loss of suction or low suction during intermittent suction use. This functional defect could compromise proper operation of the suction liners during surgical procedures.
The affected units were distributed worldwide, including the United States, Canada, and Panama.
Customers and healthcare facilities that received affected lot numbers should contact Medline Industries for instructions on product replacement or remedy.
The recalled product
- Product
- Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1092B; b) VIDEO BRONCHOSCOPY TRAY, Pack Number DYKE1666; c) SUCTION CANISTER KIT, Pack Number DYKM2196; d) SUCTION CANISTER KIT, Pack Number DYKM2196H; e) BRON
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Hazard
- suction-loss
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 (20)
- a) DYKE1092B: UDI/DI case 40889942777366
- UDI/DI each10889942777365
- Lot Numbers: 24BBK418
- 24DBH210
- b) DYKE1666: UDI/DI case 40193489708487
- UDI/DI each10193489708486
- Lot Numbers: 24ADB503
- 24CDA282
- 24CDB279
- 24DDB221
- 24EDA406
- c) DYKM2196: UDI/DI case 40195327236916
- UDI/DI each10195327236915
- Lot Numbers: 23LBF762
- 24BBB541
- 24CBI973
- 24DBH448
- d) DYKM2196H: UDI/DI case 40195327236916
- e) DYNJ24810B: UDI/DI case 40889942440611
- UDI/DI each10889942440610
Distribution
Distributed nationwide across the United States.
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