Medline Industries, Inc. CDS983189GRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10195327164485), received between Dec 1, 2022 and Dec 6, 2022 — classified as 2 injuries.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 9, 2024Class IIOpen, Classified

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

   Z-0649-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER CONTACT, ON (B)(6) 2022 A PATIENT DEVELOPED A 'STRANGE RASH' RELATING TO THE USE OF A DRAPE AFTER A LAMINECTOMY AND DISCECTOMY PROCEDURE THAT WAS NOTICED BY THE PHYSICIANS ASSISTANT AND SURGEON.

  Patient problems: Rash

  MAUDE report 15924254 ↗
• InjuryDec 1, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER CONTACT, ON (B)(6) 2022 A PATIENT DEVELOPED A 'STRANGE RASH' RELATING TO THE USE OF A DRAPE AFTER A LAMINECTOMY PROCEDURE THAT WAS NOTICED BY THE PHYSICIANS ASSISTANT AND SURGEON.

  Patient problems: Rash

  MAUDE report 15893938 ↗