Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Centurion

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Centurionsee related information
Date Initiated by FirmApril 09, 2025
Date PostedMay 15, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1765-2025
Recall Event ID 96732
Product Classification Retractor - Product Code GAD
ProductCenturion Sterile Weitlaner Retractor, Reorder: 67315
Code Information UDI/DI 10653160379867 (each) 00653160379860 (case), Lot Numbers: 2020092801, 2020100601, 2021022601, 2021032301, 2021042301, 2021060101, 2021062101, 2021090790, 2022021190, 2022032390, 2022040690, 2022061690, 2022072690, 2022091490, 2023020990, 2023100590, 2023120790, 2024012990, 2024022290, 2024040590, 2024070290, 2024080190, 2024092790, 2025011490.
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
866-359-1704
Manufacturer Reason
for Recall		Three is the potential for the retractors to puncture through the sterile packaging.
FDA Determined
Cause 2		Under Investigation by firm
ActionMedline issued a MEDLINE DEVICE RECALL notice to its consignees on 04/09/2025, The notice explained the issue, potential risk, and requested the following: REQUIRED ACTION: 1.Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.comRecall Reference #: R-25-072Recall Code: RECALL CODE 3.Your account will receive credit once the response form is submitted. 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Quantity in Commerce2100 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-