Medline medical convenience kits — Class I medical device recall Z-2147-2026

Ongoing recall by Medline Industries, LP, reported 2026-05-20, distributed nationwide. Medline has identified the presence of particulate within the fluid path of the Manifolds.

Recall number	`Z-2147-2026`
Product type	Medical device
Classification	Class I
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Medline Industries, LP, Northfield, IL, United States
Recall initiated	2026-03-24
Classified	2026-05-08
Reported by FDA	2026-05-20
Distributed	Nationwide (US)
Quantity	21,119 kits
Reason classes	specification failure
UPC / GTIN / UDI-DI	`10193489040340`, `10193489048872`, `10195327158699`, `10195327374198`, `10195327586157`, `10195327686499`, `10198459005640`, `10198459032981`, `10198459104299`, `10198459254727`, `10198459258633`, `10198459393327`, `10198459416590`, `10198459423758`, `10198459477218`, `10198459558689`, `10198459580918`, `40193489040341`, `40193489048873`, `40195327158690`, `40195327374199`, `40195327586158`, `40195327686490`, `40198459005641`, `40198459032982` and 9 more
Lot numbers	`23GBQ457`, `23HBE467`, `23HBW249`, `23HBW251`, `23IBC125`, `23IBC156`, `23KBB857`, `23KBJ681`, `23KBN009`, `23KBT543`, `23LBI829`, `23LBM984`, `24ABH036`, `24ABL640`, `24ADA538`, `24BBG055`, `24BBR688`, `24CBD613`, `24EBO156`, `24EBP711`, `24EBQ349`, `24EMG321`, `24GBP073`, `24GBS605`, `24GMA788`, `24GMH056`, `24HMA312`, `24HMB740`, `24IBF171`, `24IBK765`, `24IMI472`, `24JME459`, `24JMG837`, `24JMH356`, `24KBH753`, `24KMA339`, `24KMC197`, `24KMC940`, `24KMJ018`, `24LBH071` and 58 more

Product

Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075; 3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N; 4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250G; 5. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333D; 6. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333F; 7. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779G; 8. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779I; 9. CLOT RETRIEVAL PACK, Medline Kit Number/SKU DYNJ56140C; 10. TAVR PACK NO SYR, Medline Kit Number/SKU DYNJ62310C; 11. TAVR PACK, Medline Kit Number/SKU DYNJ62310D; 12. TAVR PACK, Medline Kit Number/SKU DYNJ62310F; 13. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911; 14. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911A; 15. CATH PACK, Medline Kit Number/SKU DYNJT6544; 16. LHK, Medline Kit Number/SKU NAM0015; 17. SLU LHK, Medline Kit Number/SKU SAMPC0706.

Reason for recall

Medline has identified the presence of particulate within the fluid path of the Manifolds.

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-2147-2026. 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.