# FDA recall Z-1114-2023

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2022-12-07.

## Product

Surgical convenience kits labeled as:  MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224B

## Reason for recall

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-1114-2023
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-07
- **Report date:** 2023-02-22

- **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-1114-2023

## Citation

> AI Analytics. FDA recall Z-1114-2023. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1114-2023. Source: US FDA. Licensed CC0.

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