# FDA recall Z-2017-2026

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

## Product

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:    1. VP SHUNT, Medline Kit Number/SKU CDS840193V;   2. SHY VP SHUNT CDS, Medline Kit Number/SKU CDS982389J;   3. VP SHUNT ADULT PACK-LF, Medline Kit Number/SKU DYNJ0117497G;   4. PICC LINE PACK, Medline Kit Number/SKU DYNJ04592K;   5. VP SHUNT PACK-LF, Medline Kit Number/SKU DYNJ0750993L;   6. PEDI VP SHUNT ADD A PACK-LF, Medline Kit Number/SKU DYNJ0753933F;   7. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861B;   8. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861D;   9. EVD VP SHUNT DBS PACK 319705, Medline Kit Number/SKU DYNJ44603C;   10. BURR HOLE SHUNT PACK, Medline Kit Number/SKU DYNJ56819G;   11. CHRISTUS CHILDRENS VP SHUNT PK, Medline Kit Number/SKU DYNJ61174A;   12. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213C;   13. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213F;   14. NASAL ENDO PACK, Medline Kit Number/SKU DYNJ84501;   15. RO VP SHUNT PACK, Medline Kit Number/SKU 

## 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-2017-2026
- **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-2017-2026

## Citation

> AI Analytics. FDA recall Z-2017-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2017-2026. Source: US FDA. Licensed CC0.

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