# FDA recall Z-0633-2025

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2024-10-09.

## Product

MEDLINE convenience kits labeled as:   1) MAMMOPLASTY-LF, REF CDS983478L;  2) MAMMOPLASTY-LF, REF CDS983478M;  3) PLASTICS FREE FLAP, REF CDS983493M;  4) PLASTIC TORSO-LF, REF CDS983496L;  5) PLASTIC TORSO-LF, REF CDS983496M;  6) PLASTIC HEAD AND NECK-LF, REF CDS983498N;  7) ACH PLASTICS BREAST-LF, REF CDS983639J;  8) ACH PLASTICS BREAST-LF, REF CDS983639K;  9) BREAST ABD, REF CDS984267J;  10) DAY SURG PLASTIC CDS, REF CDS984993N;  11) DAY SURG PLASTIC CDS, REF CDS984993O;  12) DAY SURG PLASTIC CDS, REF CDS984993P;  13) PLASTIC PACK, REF DYNJ00264L;  14) LKLND BRST CHST PK RFID-LF, REF DYNJ0101536L;  15) OCULOPLASTY PACK-LF, REF DYNJ0252232U;  16) PLASTICS PACK, REF DYNJ02615G;  17) BREAST PBM-LF, REF DYNJ0318423M;  18) FLAP RECONSTRUCTION PACK-LF, REF DYNJ0378388P;  19) BREAST PACK-LF, REF DYNJ0378394R;  20) BREAST PACK-LF, REF DYNJ0378394S;  21) BREAST PACK-LF, REF DYNJ0378394T;  22) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947K;  23) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ042894

## Reason for recall

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0633-2025
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-09
- **Report date:** 2024-12-11

- **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-0633-2025

## Citation

> AI Analytics. FDA recall Z-0633-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0633-2025. Source: US FDA. Licensed CC0.

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