# FDA recall Z-2591-2026

> **Medline Industries, LP** · Class II · device recall initiated 2026-02-27.

## Product

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes.    ANGIO PACK	  	DYNJ30565C  	DYNJ32555B  	  ANGIO PACK-LF	  	DYNJ0774765U  	  ANGIO TRAY	  	DYNJ46153A  	  ANGIOGRAM TRAY	  	DYNJ33638K  	  ANGIOGRAPHY DRAPE PK QVH-LF	  	DYNJ35110D  	  ANGIOGRAPHY PACK	  	DYNJ44293D  	  ANGIOGRAPHY PACK-LF	  	DYNJ0854485T  	DYNJ35916J  	  GENERAL ANGIO PACK	  	DYNJ57760B  	  GENERAL ENDO PACK-LF	  	DYNJ0842873J  	  JUDKINS PACK	  	DYNJ51126A  	  RADIOLOGY ANGIO MAJOR PACK	  	DYNJ62858B  	  TAVR JUDKINS PACK	  	DYNJ51127B

## Reason for recall

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA.  Products not initially reported in RES 98601.

## Distribution

US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS,  KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI,  WY and the country of Barbados.

## Key facts

- **Recall number:** Z-2591-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-27
- **Report date:** 2026-07-01

- **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-2591-2026

## Citation

> MORVS. FDA recall Z-2591-2026. Retrieved 2026-10-17 from https://api.morvs.ai/recall/Z-2591-2026. Source: US FDA. Licensed CC0.

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