# FDA recall Z-1878-2026

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

## Product

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes    TAVR PACK DYNJ69246B    ABDOMINAL VASCULAR-LF	DYNJ905291D  	  ANGIOGRAPHIC PACK	DYNJ86769  	  AORTAGRAM PACK	DYNJ26783D  	  AV FISTULA PACK CHS-LF	DYNJ35615G  	  AV SHUNT PACK-LF	DYNJ0842516G  	  CATHETER PACK	DYNJ61926  	  EP DRAPE PACK-LF	DYNJ47645C  	  EP PACK	DYNJ47782G  	  EPS ACCESSORY PACK	DYNJT2201S  	  H CLINIC VASCULAR PK	DYNJ33415A  	  HEART FAILURE PACK	DYNJ64877B  	  HYBRID PACK	DYNJ65925D  	  INTERVENTIONAL RAD PACK	DYNJ44100M  	  INTERVENTIONAL RADIOLOGY PK-LF	DYNJ0516014AG  	  MV-PACEMAKER PACK-LF	DYNJ41556F  	  NEURO RADIOLOGY RICHMOND	DYNJ68365D  	  OR HYBRID-M	DYNJ907758D, DYNJ907758F  	  PACEMAKER	DYNJ907960C  	  PACEMAKER PACK	DYNJ42557B  	  	DYNJ61411  	  	DYNJ61411A  	  	DYNJ61411B  	  	DYNJ80160  	  PACER PACK	DYNJ40952B  	  PERIPHERAL ARTERIOGRAM RAD	DYNJ61383B  	  RADIOLOGY PACK	DYNJ54762D  	  TAVR PACK	DYNJ55338B  	  	DYNJ69246A  	  VASCULAR ACCESS TRAY	DYNJ52606F  	  VA

## Reason for recall

Unapproved design changes to the products outside of the 510(k) clearance.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.

## Key facts

- **Recall number:** Z-1878-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-27
- **Report date:** 2026-04-29

- **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-1878-2026

## Citation

> AI Analytics. FDA recall Z-1878-2026. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-1878-2026. Source: US FDA. Licensed CC0.

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