Mahurkar Elite PASS Trays — Class II medical device recall Z-2319-2026

Ongoing recall by Mozarc Medical US LLC, reported 2026-06-17, distributed nationwide. The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite P

Recall number	`Z-2319-2026`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Mozarc Medical US LLC, Mansfield, MA, United States
Recall initiated	2026-04-29
Classified	2026-06-05
Reported by FDA	2026-06-17
Distributed	Nationwide (US)
Quantity	25,627
Reason classes	labeling
UPC / GTIN / UDI-DI	`10884521788428`, `10884521788435`, `10884521788442`, `10884521788459`, `10884521788473`, `10884521788480`, `10884521788497`, `10884521788527`, `10884521788534`, `10884521788541`, `10884521788558`, `10884521788565`, `10884521788572`, `10884521788589`, `10884521788602`, `10884521788619`, `10884521788626`, `10884521788664`, `10884521788671`, `10884521788688`, `10884521788695`, `10884521788701`, `10884521788718`, `10884521788725`, `10884521788732` and 1 more
Lot numbers	`241060237`, `241200034`, `241350005`, `241480021`, `241620022`, `241620407`, `241690023`, `241690216`, `241830147`, `242390056`, `242950260`, `243040007`, `243160028`, `250070005`, `250310006`, `250310009`, `250310010`, `250310011`, `250310012`, `250350008`, `250690152`, `250690153`, `250760159`, `250760180`, `250830185`, `250830186`, `250830187`, `250870012`, `250870013`, `250900066`, `250900067`, `250900298`, `250900299`, `250970052`, `251010012`, `251010013`, `251250035`, `251250036`, `251250037`, `251250039` and 45 more

Product

Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222416), 12 FR x 16cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221416), 12 FR x 20cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222420), 12 FR x 20cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221420), 12 FR x 24cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222424), 12 FR x 24cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221424), 12 FR x 30cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221430), 12.5 FR x 13 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233413), 12.5 FR x 16 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233416), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233420), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231420), 12.5 FR x 24 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233424), 12.5 FR x 24 cm, Acute Triple Lumen Catheter with Straight Extensions PASS Tray (8888231424), 12.5 FR x 30 cm, Triple Lumen Catheter with Straight Extensions PASS Tray (8888231430), 12.5FR x 13cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231413), 12.5FR x 16cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231416), 13.5 FR x 16 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213416), 13.5 Fr x 16cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211416), 13.5 FR x 20 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213420), 13.5 Fr x 20cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211420), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212413), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211413), 13.5FR x 16cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212416), 13.5FR x 20cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212420), 13.5FR x 24cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211424); for acute hemodialysis, aphaeresis, and infusion.

Reason for recall

The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.

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-2319-2026. 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.