# FDA recall Z-1399-2026

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

## Product

Medline Convenience Kits:  1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326;   2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A;   3) DRAWER #5, Model Number: ACC010475;   4) DRAWER 1 NEURO CART, Model Number: ACC010542;   5) DRAWER 2 NEURO CART, Model Number: ACC010543;   6) DRAWER 4, Model Number: ACC010722;   7) MALIGNANT HYPERTHERMIA CART, Model Number: ACC010896;   8) LIVER TRANSPLANT #57 CDS-2, Model Number: CDS860063U;   9) THOROCOTOMY CDS #24-RF, Model Number: CDS860066T;   10) CYSTO, Model Number: CDS981795G;   11) MAJOR PROCEDURE CDS, Model Number: CDS982414N;   12) TOTAL KNEE CDS, Model Number: CDS982823R;   13) VASCULAR CDS-1, Model Number: CDS982895I;   14) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069F;   15) HEART CABG CDS, Model Number: CDS983376S;   16) CRANIOTOMY, Model Number: CDS983611N;   17) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653K;   18) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653L;   19) CUH KIDNEY TRANSPLANT CDS, Model Number

## 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-1399-2026
- **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-1399-2026

## Citation

> AI Analytics. FDA recall Z-1399-2026. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1399-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*