MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION — Class II medical device recall Z-2490-2026
Ongoing recall by Medline Industries, LP, reported 2026-06-24, distributed nationwide. During an internal review, Medline identified representative samples did not meet applicable performance speci
| Recall number | Z-2490-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-05-04 |
| Classified | 2026-06-17 |
| Reported by FDA | 2026-06-24 |
| Distributed | Nationwide (US) |
| Quantity | 0 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10198459556654, 40198459556655 |
| Lot numbers | 25JBO955, 25KBC063 |
Product
MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Number/SKUDYNJ86253A
Reason for recall
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.
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-2490-2026. 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.