Mahurkar Elite PASS Trays Recall Issued by Mozarc Medical
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Mozarc Medical US LLC is recalling 25,627 units of Mahurkar Elite PASS Trays because the Tegaderm CHG dressing specified in product labeling is missing from certain lots.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 27, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
Mozarc Medical US LLC initiated a voluntary recall of Mahurkar Elite PASS Trays after determining that the Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots.
Which Products Are Affected
The recall covers 25,627 units of Mahurkar Elite PASS Trays distributed nationwide in the United States. Affected products include multiple configurations such as:
- 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), lots 241620022, 252020038
- 12 FR x 16cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222416), lots 241690023, 241830147
- and additional models with product numbers including 8888221416, 8888222420, 8888221420, 8888222424, 8888221424, 8888221430, 8888233413, 8888233416, 8888233420, 8888231420, 8888233424, 8888231424, 8888231430, 8888231413, 8888231416, 8888213416, 8888211416, 8888213420, 8888211420, 8888212413, 8888211413, 8888212416, 8888212420, and 8888211424, along with their corresponding UDI-DIs and numerous lot numbers listed in FDA recall Z-2319-2026. The products are intended for acute hemodialysis, aphaeresis, and infusion.
What You Should Do
Check product lot numbers against the FDA recall notice for affected units.
Why This Matters
Class II recall of 25,627 units distributed nationwide due to missing labeled component in medical device trays.
Source
FDA recall number Z-2319-2026, event ID 98891 (https://www.fda.gov)
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,472 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 27, 2026.
Frequently Asked Questions
Common questions about this FDA recall.