# FDA recall Z-2037-2026

> **Medline Industries, LP** · Class II · device recall initiated 2026-03-19.

## Product

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:   1. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A;   2. OCULAR PACK, Medline Kit Number/SKU DYNJ64138B;   3. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572A;   4. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572B;   5. MICROSURGERY PACK, Medline Kit Number/SKU DYNJ67284A;   6. BASIC EYE PACK, Medline Kit Number/SKU DYNJ81411A;   7. SMR SINUS PACK, Medline Kit Number/SKU DYNJ84478;   8. FESS/SEPTO PACK, Medline Kit Number/SKU DYNJ85025;   9. PLASTIC EYE PACK, Medline Kit Number/SKU DYNJ89030;   10. NEURO, Medline Kit Number/SKU DYNJ902935K;   11. OCULAR, Medline Kit Number/SKU DYNJ909065;   12. OCULAR, Medline Kit Number/SKU DYNJ909065A.

## Reason for recall

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-2037-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-19
- **Report date:** 2026-05-06

- **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-2037-2026

## Citation

> AI Analytics. FDA recall Z-2037-2026. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-2037-2026. Source: US FDA. Licensed CC0.

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