# FDA recall Z-0513-2026

> **Medline Industries, LP** · Class II · device recall initiated 2025-09-30.

## Product

MEDLINE convenience kits labeled as:    1) GENERAL AAA #11-RF, REF CDS840261AB;   2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I;   3) PERIPHERAL VASCULAR CDS, REF CDS983723J;   4) ACH OPEN HEART, REF CDS983773J;   5) VASCULAR, REF CDS984255K;   6) OPEN HEART CHILDRENS PACK-LF, REF DYNJ0161262C;   7) VASCULAR PACK-LF, REF DYNJ0421380P;   8) GEN FEM POP #14-RF, REF DYNJ21877W;   9) VASCULAR PACK, REF DYNJ22350L;   10) GENERAL CAROTID/AV TRAY #15-RF, REF DYNJ27432AC;   11) OPEN HEART PACK, REF DYNJ37284K;   12) ACH CABG ADD-ON, REF DYNJ38175L;   13) CARDIOVASCULAR PACK, REF DYNJ42921G;   14) CABG PACK-LF, REF DYNJ43207K;   15) HEART DRAPING PACK-LF, REF DYNJ43214F;   16) AAA PACK, REF DYNJ44847I;   17) CASTRO CABG-COMPONENT PACK, REF DYNJ44857U;   18) FISTULA PACK, REF DYNJ44869K;   19) MAJOR VASCULAR LEG-TEAM, REF DYNJ44879K;   20) PERMANENT PACING, REF DYNJ44886M;   21) CAROTID VASCULAR ENDARTERECTMY, REF DYNJ50528M;   22) DR DANIELSON AC PACK, REF DYNJ51038R;   23) VASCULAR CAROTID 

## Reason for recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0513-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-30
- **Report date:** 2025-11-26

- **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-0513-2026

## Citation

> AI Analytics. FDA recall Z-0513-2026. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-0513-2026. Source: US FDA. Licensed CC0.

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