# FDA recall Z-1389-2026

> **Medline Industries, LP** · Class II · device recall initiated 2026-01-07.

## Product

Medline Convenience Kits:  1) OR ARTERIOGRAM, Model Number: CDS985094F;   2) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153;   3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4A;   4) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4B;   5) VEIN PROCEDURE KIT, Model Number: DYNDA2076C;   6) CARDIAC CATH PACK-LF, Model Number: DYNJ0150605AC;   7) CATH LAB PACK-LF, Model Number: DYNJ0648473Y;   8) NBMC CATH PACK-LF, Model Number: DYNJ0803367I;   9) ANGIO PACK-LF, Model Number: DYNJ0954970I;   10) CARDIAC CATH PACK, Model Number: DYNJ19946M;   11) CATH LAB PACK, Model Number: DYNJ30955I;   12) CATH LAB PACK, Model Number: DYNJ31773K;   13) CATH PACK-LF, Model Number: DYNJ33061D;   14) DB CCL OAKWOOD PACK-LF, Model Number: DYNJ33620D;   15) CARDIAC CATH PACK MRH-LF, Model Number: DYNJ35300M;   16) CATH LAB PK, Model Number: DYNJ35643C;   17) CARDIAC CATH PACK-LF, Model Number: DYNJ39066B;   18) CATH PACK-LF, Model Number: DYNJ43101C;   19) OR ANGIO PACK-LF, Model N

## 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.

## Distribution

Worldwide distribution - US Nationwide.

## Key facts

- **Recall number:** Z-1389-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-07
- **Report date:** 2026-02-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1389-2026

## Citation

> AI Analytics. FDA recall Z-1389-2026. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1389-2026. Source: US FDA. Licensed CC0.

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