Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR C... — FDA record Z-1439-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 23, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
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
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.
Classification
Class II
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
20614 units
Agency-reported status
Ongoing
Source record identifier
Z-1439-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilitya) 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

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Apr 10, 2024
Recall initiation date
Feb 23, 2024
Center classification date
Mar 29, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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