High FDA (Devices)·Z-3105-2024·Announced 2024-09-18

Medline semi-rigid suction liners recalled due to potential suction loss

Medline Industries is recalling specific lots of semi-rigid suction liners due to potential loss of suction or low suction during use. About 1.25 million units distributed in the US, Canada, and Panama are affected.

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 FDA Class II medical device recall is based on reported adverse events, indicating confirmed harm has occurred. The recall addresses a functionality defect in a critical wound-care device, though the source does not specify hospitalization or serious-injury details that would elevate this to Severe.

Plain-English summary

Medline Industries, LP is recalling specific lots of semi-rigid suction liners (models OR515, OR526K, OR527K, and OR529K) due to reported adverse events. The recalled devices have the potential to lose suction or operate at low suction levels during intermittent suction use, which compromises their function in wound drainage applications.

Approximately 1.25 million units were distributed worldwide, including the United States, Canada, and Panama. The affected units were manufactured between September 2023 and November 2023. Specific lot numbers for each model are documented in the FDA recall notice.

Healthcare facilities and providers currently using these affected lots should discontinue use and contact Medline Industries for replacement products. Patients and care facilities that have used these devices should consult with their healthcare provider regarding any concerns about their wound care management.

This is an FDA Class II medical device recall addressing a functionality defect identified through adverse event reports.

The recalled product

Product: Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION LINER, REF OR515; b) SEMI RIGID SUCTION LINER WITH TUBING, REF OR526K; c) SEMI RIGID SUCTION LINER WITH TUBING, REF OR527K; d) SEMI RIGID SUCTION LINER WITH TUBING, REF OR529K
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Wound Suction Devices
Hazard: suction-loss
device-malfunction
Affected units: 1,250,374

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) OR515: UDI/DI 10884389968093
Lot Numbers: 93023082618C
93023082730C
93023090602C
93023090902C
93023091309C
93023091409C
93023091428C
93023091506C
93023091609C
93023091806C
93023093A10C
93023098426C
93023098623C
93023098811C
93023099605C
93023099705C
93023099806C
93023099826C
93023102613C

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by MEDLINE INDUSTRIES, LP - Northfield 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 17 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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