Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0646-2025 — MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF CDS983497L; 4) DAY SURG LARGE VAG CDS, REF CDS984995N; 5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 6) D&C/HYSTEROSCOPY PACK, REF DYNJ01921M; 7) HY

U.S. FDA — Device Enforcement · United States · 2024-10-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0646-2025
Date of alert
2024-10-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
MEDLINE INDUSTRIES, LP - Northfield
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10195327009656
Reported risk: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.