# FDA recall Z-0627-2025

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2024-10-09.

## Product

MEDLINE convenience kits labeled as:     1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C;   2) BREAST BIOPSY PACK-LF, REF DYNJ0842590G;   3) TREATMENT ROOM PACK, REF DYNJ41473G;   4) TREATMENT ROOM PACK, REF DYNJ41473I;   5) BREAST BIOPSY PACK, REF DYNJ44148G;   6) PRX BREAST PACK, REF DYNJ81776A;   7) TAMPONADE, REF DYNJ82691

## Reason for recall

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0627-2025
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-09
- **Report date:** 2024-12-11

- **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-0627-2025

## Citation

> AI Analytics. FDA recall Z-0627-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0627-2025. Source: US FDA. Licensed CC0.

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