FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: 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
- Recall number
- Z-3105-2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- 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
- Status
- Open, Classified
- Initiated
- 2024-06-27
- Posted
- 2024-09-11
- Terminated
- not on file
- 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.
- Root cause
- Process control
- Action
- Medline Industries issued a MEDICAL DEVICE RECALL notice to its consignees on 06/27/2024 via US mail and email. The notice explained the problem with the device, potential risk to the patient, and requested the consignee immediately check their stock for the affected item number and the affected lot numbers and destroy any affected inventory. Distributors were directed to notify their customers of the recall and request the affected products be destroyed. For questions: contact the Recall Department at 866-359-1704 or recalls@medline.com.
- Quantity
- 1,250,374 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KDQ
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28