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 MEDICAL PRODUCTS Circumcision kit

  • 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 CENTURION MEDICAL PRODUCTS Circumcision kitsee related information
Date Initiated by FirmMarch 16, 2026
Date PostedApril 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1824-2026
Recall Event ID 98626
510(K)NumberK213481 
Product Classification General surgery tray - Product Code LRO
ProductCENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
Code Information Medline Kit Number/SKU CIT7050F, UDI/DI each 10198459536656, UDI/DI case 40198459536657, Lot Number 25KLA002
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
866-359-1704
Manufacturer Reason
for Recall		On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.
FDA Determined
Cause 2		Under Investigation by firm
ActionMedline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its sole consignee on 3/16/2026 via email. The notice explained the issue, potential risk of use, and requested the destruction of the affected product. The firm was also directed to notify anyone to whom the product was further distributed. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Quantity in Commerce640 kits
DistributionUS Nationwide distribution in the state of South Carolina.
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.
510(K) Database510(K)s with Product Code = LRO
-
-