# FDA recall Z-2022-2026

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

## Product

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:    1. PLASTICS FREE FLAP, Medline Kit Number/SKU CDS983493N;   2. TLIF PACK, Medline Kit Number/SKU DYNJ02476O;   3. DONOR FREE FLAP PACK-LF, Medline Kit Number/SKU DYNJ0426069N;   4. DONOR FREE FLAP PACK-LF, Medline Kit Number/SKU DYNJ0426069Q;   5. MINOR MB PACK-LF, Medline Kit Number/SKU DYNJ0429303L;   6. ENDOSCOPIC SKULL BASE PACK-LF, Medline Kit Number/SKU DYNJ0753948J;   7. RR-H&N FREEFLAP BLCKWELL PK-LF, Medline Kit Number/SKU DYNJ0785741K;   8. MINIMALLY INVASIVE PACK-LF, Medline Kit Number/SKU DYNJ0843063K;   9. FREE FLAP BASIC SET-UP PK, Medline Kit Number/SKU DYNJ0991320K;   10. FREE FLAP BASIC SET-UP PK, Medline Kit Number/SKU DYNJ0991320M;   11. MLD PACK, Medline Kit Number/SKU DYNJ19521Q;   12. SINUS ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ34623C;   13. PMD PACK SURG CNTR-LF, Medline Kit Number/SKU DYNJ35305G;   14. LARYNGOSCOPY PACK, Medline Kit Number/SKU DYNJ37547D;   15. FUNCTION

## 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-2022-2026
- **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-2022-2026

## Citation

> AI Analytics. FDA recall Z-2022-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2022-2026. Source: US FDA. Licensed CC0.

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