# FDA recall Z-0649-2025

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

## Product

MEDLINE convenience kits labeled as:   1) ORTHO LAMINECTOMY-LF, REF CDS780112J;  2) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V;  3) BASIC BACK CDS, REF CDS780147N;  4) INSTRUMENTED BACK CDS, REF CDS780148Q;  5) INSTRUMENTED BACK CDS, REF CDS780148R;  6) TOTAL HIP, REF CDS920027W;  7) TOTAL HIP, REF CDS920027X;  8) TOTAL HIP, REF CDS920027Y;  9) TOTAL KNEE CDS-LF, REF CDS940047AF;  10) TOTAL KNEE CDS-LF, REF CDS940047AG;  11) TOTAL HIP CDS-LF, REF CDS940048AF;  12) TOTAL HIP CDS-LF, REF CDS940048AG;  13) TOTAL HIP CDS-LF, REF CDS940048AI;  14) TOTAL KNEE, REF CDS940072W;  15) TOTAL KNEE, REF CDS940072Y;  16) TOTAL KNEE REPLACEMENT CDS, REF CDS940823AB;  17) TOTAL KNEE CDS, REF CDS940842Y;  18) TOTAL HIP CDS, REF CDS940843AA;  19) FRACTURE TABLE-LF, REF CDS940857K;  20) FRACTURE TABLE-LF, REF CDS940857L;  21) EXTREMITY-LF, REF CDS940860P;  22) EXTREMITY-LF, REF CDS940860Q;  23) KNEE/SHOULDER, REF CDS940911Q;  24) TOTAL HIP CDS, REF CDS940963Y;  25) SHOULDER CDS, REF CDS941065L;  26) TOT

## 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-0649-2025
- **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-0649-2025

## Citation

> AI Analytics. FDA recall Z-0649-2025. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-0649-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*