Z-0758-2025Class II

ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K

Name: Z-0758-2025 ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-11-12
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-11-12 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K on 2024-11-12. FDA classified it as Class II and gives the reason as "Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0758-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-12
Posted: 2024-12-23
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
Product code: HTF Curette
Reason for recall: Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On November 25, 2024, the firm notified customers via letters titled IMMEDIATE ACTION REQUIRED. Customers were informed that specific items and lots of Pure Pouch Single-Sterile and Sterile Kits are being recalled due to weak seals. Affected product must be destroyed. The letter included instructions on actions to take to be issued a credit. Customers should immediately check their stock for affected product and quarantine all units. Affected lots should be destroyed. When the recalling firm has received your completed destruction form, your account will be issued a credit, if applicable. If you have any questions, please contact 866-359-1704.
Quantity in commerce: 21,440 total
Distribution: US Nationwide distribution.
Product codes and lots: UDI: 10653160382140 (ea) 00653160382143 (case); Lot 2023012490

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0758-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0754-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-23
Z-0755-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-23
Z-0756-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-23
Z-0757-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-23
Z-0758-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-23
Z-0759-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-23
Z-0760-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-23

Product code HTF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)