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
- 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 (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.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03