FDA-Device2026-02-25Class IIPROCESSING DEFECT

Medline medical convenience kits recalled for sterilization equipment calibration issues

OTHERNationwide distributionMedical devices

What this means

Medline has recalled six types of surgical and medical convenience kits due to calibration problems with sterilization equipment. While the kits went through sterilization and packaging processes, the calibration issues may have compromised the sterility of the products. No injuries have been reported.

Check if you have any of the affected Medline kits by model number (DYKMBNDL130, DYKMBNDL130A, DYKMBNDL4, LC295, DYKM1977C, or CVI4300)
Verify the lot number on the package against the FDA recall list
Stop using any affected kits immediately
Contact Medline or your healthcare facility for instructions on replacement or return

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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

553 units

Manufactured in

3 Lakes Dr, Northfield, IL, United States

Products

Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4; 4) NICU LINE CHANGE TRAY, Model Number: LC295; 5) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 6) PICC CATHETER INSERTION TRAY, Model Number: CVI4300

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1401-2026

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

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