# FDA recall Z-1397-2026

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

## Product

Medline Convenience Kits:  1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499;   2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C;   3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158;   4) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170;   5) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170A;   6) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170B;   7) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182;   8) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182A;   9) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182B;   10) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183;   11) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183A;   12) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183B;   13) KIT STC FACIAL FRACTURE, Model Number: DYKMBNDL34A;   14) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39;   15) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39A;   16) KIT SURG ONC MASTECTOMY, Model Number: DYKMBNDL39C;   17) KIT

## 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-1397-2026
- **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-1397-2026

## Citation

> AI Analytics. FDA recall Z-1397-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1397-2026. Source: US FDA. Licensed CC0.

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