FDA-Device2026-02-25Class IIPACKAGING DEFECT

Medline surgical and central line kits recalled for sterilization equipment calibration issues

OTHERNationwide distributionMedical devices

What this means

Medline identified calibration problems with sterilization equipment used to process over 24 models of surgical procedure kits and central line trays. Although the kits went through sterilization cycles, the equipment calibration issues may have affected their sterility. No injuries have been reported.

Check your inventory for Medline surgical kits and trays matching the recalled model numbers and lot numbers listed on the FDA website
Do not use recalled kits until you verify they are safe
Contact Medline or your facility's supply chain for instructions on returning or replacing affected products
Report any adverse events to Medline customer service or the FDA MedWatch program

Get recalls like this in a free plain-English brief every Sunday.Get alerts ↓

The agency's original wording

Hazard

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.

Intended for

All ages

Illnesses reported

None reported

Sold states

Worldwide distribution - US Nationwide.

Affected count

5346 units

Manufactured in

3 Lakes Dr, Northfield, IL, United States

Products

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) KIT SURG ONC LAP DIAG/PORT INS, Model Number: DYKMBNDL153C; 8) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43A; 9) KIT SURG ONC PORT INSERTION, Model Number: DYKMBNDL43C; 10) VEIN PROCEDURE KIT, Model Number: DYNDA2076B; 11) VEIN PROCEDURE KIT, Model Number: DYNDA2076D; 12) VEIN PROCEDURE KIT, Model Number: DYNDA2076F; 13) PLACENTA KIT, Model Number: DYNDA2322B; 14) NICU CENTRAL LINE TRAY, Model Number: DYNDC2407A; 15) NICU CENTRAL LINE TRAY, Model Number: DYNDC2407B; 16) PICC LINE TRAY, Model Number: DYNJ40500A; 17) VENOUS ACCESS PACK, Model Number: DYNJ42694C; 18) AV FISTULA CREATION PACK-LF, Model Number: DYNJ53427B; 19) PICC LINE, Model Number: DYNJ55546D; 20) PICC TRAY, Model Number: DYNJ63199A; 21) PICC KIT 4F SL PL MAX BARRIER, Model Number: DYNJ70141MB; 22) PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB; 23) VEIN PACK, Model Number: DYNJ84239; 24) PICC INSERTION TRAY W/O CATH, Model Number: PICCNC0004

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1391-2026

More Medline recalls

FDA-Device2026-09-09
Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
FDA-Device2026-09-09
Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
FDA-Device2026-09-09
Medline Convenience Kits recalled for sterility packaging breach risk
FDA-Device2026-09-09
Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
FDA-Device2026-09-09
Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk

Want us to check the next one for you?

We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.