# FDA recall Z-1809-2025

> **MEDLINE INDUSTRIES, LP - Northfield** · Class I · device recall initiated 2025-04-22.

## Product

Medline Kits containing Codman Disposable Perforator 14 mm:    1. CRANI ADD A PACK, SKU DYNJ30926O  2. CRANIOTOMY, SKU CDS983611N  3. CRANIOTOMY CDS, SKU CDS983467J  4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927  5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A

## Reason for recall

Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.

## Distribution

US distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution.

## Key facts

- **Recall number:** Z-1809-2025
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-22
- **Report date:** 2025-06-11

- **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-1809-2025

## Citation

> AI Analytics. FDA recall Z-1809-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1809-2025. Source: US FDA. Licensed CC0.

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