Data Foundry

Medical device recalls 2025

Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack — Class II medical device recall Z-1887-2025

Ongoing recall by Mozarc Medical US LLC, reported 2025-06-11, distributed nationwide. Potential breach of sterile barrier packaging.

Recall numberZ-1887-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMozarc Medical US LLC, Mansfield, MA, United States
Recall initiated2025-04-23
Classified2025-05-30
Reported by FDA2025-06-11
DistributedNationwide (US)
Countries outside the USCA, MX
Quantity95,938 units
Reason classessterility
UPC / GTIN / UDI-DI20884521157726, 20884521157795, 20884521157863, 20884521157931
Serial numbers2234800132, 2302500141, 2302500148, 2305300142, 2305300144, 2305300177, 2313800083, 2324100168, 2324100310, 2324100311, 2405800229, 2426300218, 2426700122, 2427700199
Model numbers8888119368P, 8888123408P, 8888128458P, 8888133508P

Product

Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

Reason for recall

Potential breach of sterile barrier packaging.

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-1887-2025. 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.