# FDA recall Z-2026-2026

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

## Product

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:    1. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ0532910L;   2. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ39461J;   3. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060I;   4. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060J;   5. NEURO BASIN KIT, Medline Kit Number/SKU DYNJ80200B;   6. NEURO-SPINE BASIN PACK, Medline Kit Number/SKU DYNJ83019;   7. ENT PACK, Medline Kit Number/SKU DYNJ86328;   8. EDMOND SPINE PACK, Medline Kit Number/SKU DYNJ89263;   9. ENT PACK, Medline Kit Number/SKU DYNJ89675;   10. ENT PACK, Medline Kit Number/SKU DYNJ89675A;   11. ENT/PAIN PACK, Medline Kit Number/SKU DYNJT7493.

## 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-2026-2026
- **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-2026-2026

## Citation

> AI Analytics. FDA recall Z-2026-2026. Retrieved 2026-07-30 from https://api.ai-analytics.org/recall/Z-2026-2026. Source: US FDA. Licensed CC0.

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