# FDA recall Z-2645-2026

> **Medela Inc** · Class II · device recall initiated 2026-06-05.

## Product

Brand Name: Medela  Product Name: ENFit ExSet Strl 60  2.0ml PV 1ct EN  Model/Catalog Number: ENF060182LD / 101033086  Software Version: N/A  Product Description: Enteral Extension Set, Length 60  Orange-Striped Minibore Tubing,    (Approx. Priming Vol. 2.00 mL), ENFit¿  Component: N/A

## Reason for recall

May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.

## Distribution

US distribution to the following states: AZ, CA, CO, FL, HI, IL, IN, MD, MI, MN, MO, NC, NJ, NY,  OR, PA, TX, VA.

## Key facts

- **Recall number:** Z-2645-2026
- **Recalling firm:** Medela Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-05
- **Report date:** 2026-07-08

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2645-2026

## Citation

> MORVS. FDA recall Z-2645-2026. Retrieved 2026-10-22 from https://api.morvs.ai/recall/Z-2645-2026. Source: US FDA. Licensed CC0.

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