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

Recall Z-1079-2023 — Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECOVERY CDS h. GENERAL ABD CDS i. BURN CDS j. MINOR k. MAJOR VASCULAR l. BASIC CORE CDS m. ROBOTIC PROCEDURE n. MAJOR VASCU

U.S. FDA — Device Enforcement · United States · 2022-11-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1079-2023
Date of alert: 2022-11-17
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): 40889942614135

Reported risk: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

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.

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