# FDA recall Z-0165-2025

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2024-09-04.

## Product

Medline brand medical procedure convenience kits, labeled as:    a) PLASTIC PACK, REF DYNJ42735A;   b) DR SELEM PACK, REF DYNJ43457;   c) BREAST PK TEGH-LF, REF DYNJ46717A;   d) BREAST PK TEGH-LF, REF DYNJ46717A;   e) BREAST BIOPSY-LF, REF DYNJ53205B;   f) BREAST BIOPSY-LF, REF DYNJ53205B;   g) PLASTIC PACK, REF DYNJ57895;   h) SEPTOPLASTY PACK WRO-LF, REF DYNJ62803;   i) BREAST PACK, REF DYNJ64376;   j) CSTM PK SURGISTART MAINE PLAST, REF DYNJ66619A;   k) PLASTIC PACK, REF DYNJ68030;   l) CUSTOM PLASTIC PACK, REF DYNJ68062;   m) PLASTIC LIMB SJHC-LF, REF DYNJ84997

## Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

## Distribution

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

## Key facts

- **Recall number:** Z-0165-2025
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-04
- **Report date:** 2024-10-30

- **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-0165-2025

## Citation

> AI Analytics. FDA recall Z-0165-2025. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0165-2025. Source: US FDA. Licensed CC0.

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