Data Foundry

Medical device recalls 2026

Medline Convenience Kits: 1) PICC LINE TRAY — Class II medical device recall Z-2094-2026

Ongoing recall by Medline Industries, LP, reported 2026-05-13, distributed nationwide. Medline has identified issues related to calibration of the equipment used to sterilize and package the device

Recall numberZ-2094-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMedline Industries, LP, Northfield, IL, United States
Recall initiated2026-01-07
Classified2026-05-07
Reported by FDA2026-05-13
DistributedNationwide (US)
Quantity5,562 units
Reason classessterility
UPC / GTIN / UDI-DI10193489248227, 10193489311730, 10193489499926, 10195327056520, 10195327059484, 10195327200091, 10195327241322, 10195327274467, 10195327299774, 10195327345624, 10195327350581, 10195327514334, 10195327517366, 10195327572020, 10198459000430, 10198459000553, 10198459018978, 10198459110313, 10198459216060, 10198459278884, 10198459290992, 10653160256397, 10889942197477, 10889942722808, 10889942722822 and 27 more
Lot numbers20LDC151, 21ABI600, 21ADA546, 21ADA547, 21BDB379, 21CDB078, 21CDC422, 21DBA072, 21IDC222, 21JBV496, 21JDB458, 21LBT037, 21LDB744, 21OBA058, 22ADC105, 22BBP290, 22BDA862, 22BDB354, 22CBY021, 22CDC433, 22DDA763, 22EBG055, 22EBO541, 22FDB218, 22FME865, 22IBK412, 22IBM493, 22IBN124, 22IBO930, 22IBQ424, 22JBN171, 22LBG357, 22LME863, 23ABC583, 23ABK335, 23BBA792, 23BBB100, 23BBS866, 23BDB271, 23BMF790 and 56 more
Model numbers00-401993O, ACC010268B, ACC010268C, ACC010487, CVI3650, DYKM2170, DYKM2274, DYKMBNDL153C, DYKMBNDL43A, DYKMBNDL43C, DYNDA2076B, DYNDA2076D, DYNDA2076F, DYNDA2322B, DYNDC2407A, DYNDC2407B, DYNJ40500A, DYNJ42694C, DYNJ53427B, DYNJ55546D, DYNJ63199A, DYNJ70141MB, DYNJ70152MB, DYNJ84239, DYNJ88152 and 1 more

Product

Medline Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268B; 3) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268C; 4) TRAY 6 CENTRAL LINE A, Model Number:ACC010487; 5) PEDS PICC INSERTION TRAY, Model Number:CVI3650; 6) LINE ATTIRE KIT, Model Number:DYKM2170; 7) PK BNDL CENT LINE PROTECT KIT, Model Number:DYKM2274; 8) KIT SURG ONC LAP DIAG/PORT INS, Model Number:DYKMBNDL153C; 9) KIT SURG ONC INSERT CENT.VENOU, Model Number:DYKMBNDL43A; 10) KIT SURG ONC PORT INSERTION, Model Number:DYKMBNDL43C; 11) VEIN PROCEDURE KIT, Model Number:DYNDA2076B; 12) VEIN PROCEDURE KIT, Model Number:DYNDA2076D; 13) VEIN PROCEDURE KIT, Model Number:DYNDA2076F; 14) PLACENTA KIT, Model Number:DYNDA2322B; 15) NICU CENTRAL LINE TRAY, Model Number:DYNDC2407A; 16) NICU CENTRAL LINE TRAY, Model Number:DYNDC2407B; 17) PICC LINE TRAY, Model Number:DYNJ40500A; 18) VENOUS ACCESS PACK, Model Number:DYNJ42694C; 19) AV FISTULA CREATION PACK-LF, Model Number:DYNJ53427B; 20) PICC LINE, Model Number:DYNJ55546D; 21) PICC TRAY, Model Number:DYNJ63199A; 22) PICC KIT 4F SL PL MAX BARRIER, Model Number:DYNJ70141MB; 23) PICC KIT 5F DL PL MB, Model Number:DYNJ70152MB; 24) VEIN PACK, Model Number:DYNJ84239; 25) NEXTON PACK, Model Number:DYNJ88152; 26) PICC INSERTION TRAY W/O CATH, Model Number:PICCNC0004

Reason for recall

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

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-2094-2026. 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.