# FDA recall Z-0178-2025

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

## Product

Medline brand medical procedure convenience kits, labeled as:   1) EYE PACK, REF DYNJ19492L;  2) PHACO PACK, REF DYNJ22354L;  3) EYE PACK, REF DYNJ24573K;  4) EYE PACK, REF DYNJ30327A;  5) BASIC CATARACT PACK, REF DYNJ36868F;  6) BASIC RETINA PACK, REF DYNJ40811A;  7) OPHTHALMOLOGY PACK CKHA-LF, REF DYNJ41769A;  8) CATARACT PACK WRO-LF, REF DYNJ41861;  9) EYE PACK, REF DYNJ43911;  10) PHACO PACK, REF DYNJ44748I;  11) DR DRUMMOND EYE PACK, REF DYNJ45344G;  12) OPHTHALMIC PACK, REF DYNJ47275A;  13) CATARACT PACK, REF DYNJ49412B;  14) CATARACT PACK, REF DYNJ50948A;  15) CATARACT PACK, REF DYNJ50948A;  16) CATARACT DR MALONE PACK, REF DYNJ51590A;  17) CATARACT DR MALONE PACK, REF DYNJ51590A;  18) CUSTOM EYE TRAY, REF DYNJ51821B;  19) EYE SURGERY PACK, REF DYNJ53097C;  20) CATARACT KIT, REF DYNJ53944;  21) EYE PACK, REF DYNJ54847D;  22) PK, OPHTH-EYE, REF DYNJ55070B;  23) EYE PACK, REF DYNJ55320D;  24) PK, OPHTH-RETINA, REF DYNJ59253B;  25) RETINA PACK, REF DYNJ60515;  26) ASED KIT, REF DYN

## 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-0178-2025
- **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-0178-2025

## Citation

> AI Analytics. FDA recall Z-0178-2025. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-0178-2025. Source: US FDA. Licensed CC0.

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