Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID… — Class II medical device recall Z-3105-2024
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-09-18, distributed nationwide. Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500
| Recall number | Z-3105-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-06-27 |
| Classified | 2024-09-11 |
| Reported by FDA | 2024-09-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, PA |
| Quantity | 1,250,374 units |
| UPC / GTIN / UDI-DI | 10884389968093, 10888277253087, 10888277253094, 10888277253100 |
| Lot numbers | 93023082618C, 93023082730C, 93023090602C, 93023090902C, 93023091309C, 93023091409C, 93023091427C, 93023091428C, 93023091506C, 93023091609C, 93023091709C, 93023091806C, 93023091824C, 93023092709C, 93023093227C, 93023093327C, 93023093A10C, 93023098426C, 93023098623C, 93023098811C, 93023098824C, 93023098827C, 93023099605C, 93023099705C, 93023099806C, 93023099826C, 93023101409C, 93023102613C, 93023102718C, 93023102815C, 93023102920C, 93023103015C, 93023103026C, 93023103120C, 93023103126C, 93023103209C, 93023103309C, 93023103316C, 93023103B08C, 93023106626C and 45 more |
| Model numbers | OR515, OR526K, OR527K, OR529K |
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
Reason for recall
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3105-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.