Recall archive / FDA device enforcement
Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION LINER, REF OR515; b) SEMI RIGID SUCTION L... — FDA record Z-3105-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 27, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- 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.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 1,250,374 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-3105-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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, 93023102718C, 93023102815C, 93023102920C, 93023103015C, 93023103120C, 93023103316C, 93023103B08C, 93023106628C, 93023106721C, 93023107028C, 93023107225C, 93023108512C, 93023108712C, 93023112721C, 93023112828C, 93023113027C, 93023113327C, 93023113626C, 93023113C12C, 93023116906C, 93023117013C, 93023117106C, 93023117118C, 93023117212C, 93023117301C, 93023117317C, 93023117401C, 93023117420C, 93023117506C, 93023117512C, 93023117618C, 93023117721C, 93023117806C, 93023117917C, 93023118018C, 93023123D02C, 93024013602D; b) OR526K: UDI/DI 10888277253087, Lot Numbers: 93023103026C, 93023103126C, 93023106626C, 93023113621C, 93023113725C, 93023116708C, 93023117809C, 93023117920C, 93023118025C; c) OR527K: UDI/DI 10888277253094, Lot Numbers: 93023091427C, 93023093227C, 93023093327C, 93023098827C, 93023106629C, 93023113615C, 93023116708C, 93023117815C, 93023117817C, 93023117915C; d) OR529K: UDI/DI 10888277253100, Lot Numbers: 93023091709C, 93023091824C, 93023092709C, 93023098824C, 93023101409C, 93023103209C, 93023103309C, 93023106629C, 93023116710C, 93023117815C, 93023117922C, 93023118022C, 93023124606C. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 18, 2024
- Recall initiation date
- Jun 27, 2024
- Center classification date
- Sep 11, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.