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Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745...

FDA Device Recall #Z-1439-2024 — Class II — February 23, 2024

Recall Summary

Recall Number Z-1439-2024
Classification Class II — Moderate risk
Date Initiated February 23, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm MEDLINE INDUSTRIES, LP - Northfield
Location Northfield, IL
Product Type Devices
Quantity 20614 units

Product Description

Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR CURETTE (505629), Product Code 67050; c) STERILE FOX DERMAL CURETTE, 5MM(32923), Product Code 67430; d) STERILE EXCAVATOR CURETTE (P/S), Product Code I67970; e) ST BUCK EAR CURETTE BLNT STR SZ 00, Product Code I68040; f) STERILE BRUNS CURETTE #4 (BC400S), Product Code I68340; g) 6MM FOX DERMAL CURETTE STERILE, Product Code I68380; h) STERILE KEVORKIAN CURETTE 4MM (KEC4S), Product Code I68470; i) ST ENDOCERVICAL BIOPSY CURETTE 2MM, Product Code I68480

Reason for Recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

Lot / Code Information

a) 66745, UDI/DI 70653160060330 (case) 00653160060331 (each), Lot Numbers: 2023103090; b) 67050, UDI/DI 00653160357509 (case) 10653160357506 (each), Lot Numbers: 2023103090; c) 67430, UDI/DI 10653160123514 (case) 00653160123517 (each), Lot Numbers: 2023022190; d) I67970, UDI/DI 20653160224744 (case) 00653160224740 (each), Lot Numbers: 2023041390, 2023041490, 2023061990, 2023101290; e) I68040, UDI/DI 20653160228605 (case) 00653160228601 (each), Lot Numbers: 2023022190, 2023102090; f) I68340, UDI/DI 00653160279863 (case) 10653160279860 (each), Lot Numbers: 2023042490; g) I68380, UDI/DI 00653160284553 (case) 10653160284550 (each), Lot Numbers: 2023032790, 2023101790; h) I68470, UDI/DI 00653160290721 (case) 10653160290728 (each), Lot Numbers: 2023032190, 2023032390; i) I68480, UDI/DI 00653160292640 (case) 10653160292647 (each), Lot Numbers: 2023013190

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Z-2566-2025 Class I Medline medical convenience kits labeled as: ... Jul 25, 2025
Z-2479-2025 Class II Medline Kits containing BD SureStep Foley Tray ... Jul 23, 2025
Z-2460-2025 Class I Medline ReNewal Reprocessed St. Jude Medical Re... Jul 14, 2025
Z-2452-2025 Class II The Medline General Surgery Tray is customized ... Jul 8, 2025

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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