# FDA recall Z-2091-2026

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

## Product

Medline Convenience Kits:  1) ANGIO PROCEDURE PACK, Model Number:00-401824AA;   2) ENDO KIT W/SYRINGE, Model Number:DYKE1743;   3) BGMC ANGIOGRAPHY PACK-LF, Model Number:DYNJ0800934D;   4) GENERAL ENDO PACK-LF, Model Number:DYNJ0842873J;   5) ANGIO PROCEDURE PACK, Model Number:DYNJ32328;   6) OR ANGIO PACK-LF, Model Number:DYNJ43415C;   7) ANGIO PACK II, Model Number:DYNJ44066A;   8) SOUTH CATH LAB PACK, Model Number:DYNJ61978A;   9) BIOPSY ANGIO TRAY ALEX, Model Number:DYNJ63542B;   10) SURGICAL TECH KIT, Model Number:DYNJ907452;   11) ANGIOGRAPHY PACK, Model Number:DYNJC2371G;   12) SPECTRUM HEALTH CATH PACK-LF, Model Number:PHS853965G

## 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-2091-2026
- **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-2091-2026

## Citation

> AI Analytics. FDA recall Z-2091-2026. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-2091-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*