# FDA recall Z-1395-2026

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

## Product

Medline Convenience Kits:  1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U;   2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V;   3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W;   4) MAJOR LAPAROTOMY CDS, Model Number: CDS860015X;   5) MINOR LAPAROTOMY CDS, Model Number: CDS860016P;   6) MINOR LAPAROTOMY CDS, Model Number: CDS860016Q;   7) MINOR LAPAROTOMY CDS, Model Number: CDS860016R;   8) MINOR LAPAROTOMY CDS, Model Number: CDS860016S;   9) LAP GASTRIC BYPASS CDS, Model Number: CDS860146M;   10) NEW LONDON MINOR CDS, Model Number: CDS982518M;   11) NEW LONDON MINOR CDS, Model Number: CDS982518N;   12) NEW LONDON MINOR CDS, Model Number: CDS982518O;   13) NEW LONDON MINOR CDS, Model Number: CDS982518P;   14) GENERAL LAPAROSCOPY CDS, Model Number: CDS983311J;   15) LAVH CDS, Model Number: CDS983411G;   16) NHP ROBOTIC GENERAL CDS, Model Number: CDS984244J;   17) ROBOTIC-LF, Model Number: CDS984543C;   18) CYSTO CDS, Model Number: CDS984592G;   19) CYSTO CDS, Model Number: CDS984

## 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-1395-2026
- **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-1395-2026

## Citation

> AI Analytics. FDA recall Z-1395-2026. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-1395-2026. Source: US FDA. Licensed CC0.

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