# FDA recall Z-1057-2026

> **Medline Industries, LP** · Class II · device recall initiated 2025-11-26.

## Product

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:    1) PRE OP KIT, Medline kit SKU DYKS1093B;   2) PRE OP KIT, Medline kit SKU DYKS1124C;   3) PRE OP KIT, Medline kit SKU DYKS1128C;   4) PREOP KIT, Medline kit SKU DYKS1130B;   5) PRE OP KIT, Medline kit SKU DYKS1163G;   6) PRE OP KIT SURGERY, Medline kit SKU DYKS1263G;   7) PREOP KIT, Medline kit SKU DYKS1313A;   8) PRE OP KIT, Medline kit SKU DYKS1325A;   9) ADULT PRE OP KIT, Medline kit SKU DYKS1337D;   10) PRE OP KIT ADULT, Medline kit SKU DYKS1362A;   11) PRE-OP - OUTPATIENT KIT, Medline kit SKU DYKS1378B;   12) PRE-OP INPATIENT KIT, Medline kit SKU DYKS1379B;   13) PRE OP KIT, Medline kit SKU DYKS1382A;   14) PRE OP KIT, Medline kit SKU DYKS1416F;   15) PREOP KIT, Medline kit SKU DYKS1448B;   16) PRE-OP KIT, Medline kit SKU DYKS1458F;   17) PRE OP KIT, Medline kit SKU DYKS1467B;   18) PRE OP KIT, Medline kit SKU DYKS1468;   19) PRE-OP, Medline kit SKU DYKS1482A;   20) ADULT PRE OP, 

## Reason for recall

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1057-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-26
- **Report date:** 2026-01-21

- **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-1057-2026

## Citation

> AI Analytics. FDA recall Z-1057-2026. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-1057-2026. Source: US FDA. Licensed CC0.

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