Data Foundry

Medical device recalls 2026

Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG… — Class II medical device recall Z-1468-2026

Ongoing recall by Medline Industries, LP, reported 2026-03-04, distributed nationwide. Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include si

Recall numberZ-1468-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMedline Industries, LP, Northfield, IL, United States
Recall initiated2026-01-08
Classified2026-02-24
Reported by FDA2026-03-04
DistributedNationwide (US)
Quantity150
Reason classespackaging
UPC / GTIN / UDI-DI10195327015954, 40195327015955
Lot numbers24IME953, 25CMA708

Product

Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167

Reason for recall

Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.

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-1468-2026. 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.