Class II — Medline Industries, LP
| Recalling firm | Medline Industries, LP |
|---|---|
| Registered facility | View this company's 31 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. |
| Product | MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc. (see the recall documents for the full list of products) |
| Quantity | 217390 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI. |
| Initiated | 2026-05-04 |
| Classified | 2026-06-17 |
| Recall number | Z-2491-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medline Industries, LP (Z-2491-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98994/
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