# FDA recall Z-3095-2024

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2024-05-07.

## Product

Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm.  Item Number: HARH36R.

## Reason for recall

Potential for an incomplete seal on the packaging tray.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-3095-2024
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-07
- **Report date:** 2024-09-18

- **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-3095-2024

## Citation

> AI Analytics. FDA recall Z-3095-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-3095-2024. Source: US FDA. Licensed CC0.

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