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Lower risk Medical device recall · FDA · Published November 12, 2024

Medline ST Reprocessed Bruns Curette #00 (BC00) Recall: Sterility Risk

Medline recalls ST Reprocessed Bruns Curette #00 (BC00) due to weak seals risking sterility breaches and infection. Affected units have specific UDI and lot numbers.

🇺🇸 FDA recall #Z-0758-2025Medical deviceMedline ›
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Contact the company

Recalling firmMEDLINE INDUSTRIES, LP - Northfield3 Lakes Dr · Northfield, IL 60093-2753
✎ GovInfoNow plain-language explainer

Medline is recalling ST Reprocessed Bruns Curette #00 (BC00) because weak seals might cause sterility breaches that aren't detectable to users, increasing infection risk. This affects dental instruments that have been reprocessed. Read more at govinfonow.com/recall/53502-medline-st-reprocessed-bruns-curette-00-bc00-recall-sterility-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/53502-medline-st-reprocessed-bruns-curette-00-bc00-recall-sterility-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0758-2025

Cite this page

“Medline ST Reprocessed Bruns Curette #00 (BC00) Recall: Sterility Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53502-medline-st-reprocessed-bruns-curette-00-bc00-recall-sterility-risk. Based on FDA recall #Z-0758-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0758-2025%22&limit=1).

The FDA announced on Nov. 12, 2024, that Medline Industries LP recalled ST Reprocessed Bruns Curette #00 due to weak seals that may breach sterility and cause infection. Owners should contact the company for a refund. The agency issued recall number Z-0758-2024.

How to tell if you have it

  • Brand: Medline
  • Product: ST Reprocessed Bruns Curette #00 (BC00)
  • Medline Item No.: 67600K
  • Lot code: 2023012490
  • Sold nationwide in the US

The hazard

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.

Context

GovInfoNow's records show MEDLINE INDUSTRIES LP - Northfield has had 119 other recalls since Oct. 22, 2021. Other recent recalls include Medline medical kits with light failure (July 25, 2025), Foley Tray Kits with incorrect labeling (July 23, 2025), and Reprocessed St. Jude Catheters that may contain particulates (July 14, 2025). Similar product recalls include Medline Convenience Kits with potential sterility breach (June 12, 2026) and calibration issues (Jan. 7, 2026).

How to tell if you have this one

Check for the UDI: 10653160382140 (each) or 00653160382143 (case), and lot number 2023012490 on the product packaging.

  • Brand
    Medline
  • Category
    Medical device
FDA recall event · 7 products

All 7 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution.
Recall numberProduct, codes & lots
Z-0754-2025STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695; UDI: 00653160024869 (ea) 60653160024861 (case); Lot 2023011990
Z-0755-2025O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000; UDI: 10193489191349 (ea) 20193489191346 (case); Lot 2023052490
Z-0756-2025ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870; UDI: 00653160196894 (ea) 30653160196895 (case); Lot 2023091290
Z-0757-2025STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790; UDI: 00653160007671 (ea) 50653160007676 (case); Lot 2023012390
Z-0758-2025ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K; UDI: 10653160382140 (ea) 00653160382143 (case); Lot 2023012490
Z-0759-2025ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785; UDI: 10653160327141 (ea) 00653160327144 (case); Lot 2023021390
Z-0760-2025RUMMELL, Medline Item No. ST006ST; UDI: 10653160251224 (ea) 00653160251227 (case); Lot 2023111490
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the UDI: 10653160382140 (each) or 00653160382143 (case) and lot number 2023012490 on the product packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 50 days after the firm started it.

1. Firm started the recall: Nov 12, 202412. FDA classified it Class II: Dec 23, 202423. Published in FDA’s Enforcement Report: Jan 1, 2025320242025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is there a risk of serious injury?

The recall addresses infection risk from sterility breaches, not physical injury. The hazard level is low risk.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0758-2025 (November 12, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0758-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA