# FDA recall Z-2109-2026

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

## Product

See full list in RES, exceeds character limit  1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G;   2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407P;   3) ROBOTIC GYN CDS-1, Model Number: CDS982893I;   4) GYN LAPAROSCOPY CDS, Model Number: CDS983300J;   5) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G;   6) ROBOTIC-LF, Model Number: CDS984543D;   7) ROBOTIC-LF, Model Number: CDS984543F;   8) ROBOTIC-LF, Model Number: CDS984543G;   9) ROBOTIC-LF, Model Number: CDS984543I;   10) GYN CDS, Model Number: CDS984860F;   11) GYN LAP PELVI, Model Number: CDS985423G;   12) GYN KIT, Model Number: DYKM1657A;   13) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL100;   14) KIT ROBOTICS GYN, Model Number: DYKMBNDL109;   15) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116D;   16) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116F;   17) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119;   18) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119A;   19) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168;   20) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168A;   21) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184D;   22) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91;

## 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 - US Nationwide distribution.

## Key facts

- **Recall number:** Z-2109-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-07
- **Report date:** 2026-05-13

- **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-2109-2026

## Citation

> AI Analytics. FDA recall Z-2109-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2109-2026. Source: US FDA. Licensed CC0.

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