# FDA recall Z-2016-2026

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

## Product

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:    1. OPEN HEART CDS PART A, Medline Kit Number/SKU CDS840402AI;   2. OPEN HEART CDS, Medline Kit Number/SKU CDS984890V;   3. RR-NEURO VASCULAR PACK-LF, Medline Kit Number/SKU DYNJ0394874L;   4. VP SHUNT PACK-LF, Medline Kit Number/SKU DYNJ0750993M;   5. PEDI VP SHUNT ADD A PACK-LF, Medline Kit Number/SKU DYNJ0753933G;   6. FESS-MB PACK-LF, Medline Kit Number/SKU DYNJ0888159I;   7. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861C;   8. POSTERIOR LUMBAR PACK, Medline Kit Number/SKU DYNJ42626B;   9. CV CUTDOWN PACK, Medline Kit Number/SKU DYNJ45374F;   10. X RAY CLOSED PACK, Medline Kit Number/SKU DYNJ48949C;   11. RFD- AAA PACK, Medline Kit Number/SKU DYNJ54242B;   12. NEURO LAM, Medline Kit Number/SKU DYNJ64188A;   13. LIVE OAK SINUS ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ69223;   14. FEM POP PACK, Medline Kit Number/SKU DYNJ81423C;   15. ENS FREEFLAP PROCDURE - LF, 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-2016-2026
- **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-2016-2026

## Citation

> AI Analytics. FDA recall Z-2016-2026. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-2016-2026. Source: US FDA. Licensed CC0.

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