Centurion Circumcision Kit, 640 Units, Unsterile - Class II Recall

Class 2 Device Recall CENTURION MEDICAL PRODUCTS Circumcision kit

• FDA Home

• Medical Devices

- Databases

| |

| 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 | ) |

| | Class 2 Device Recall CENTURION MEDICAL PRODUCTS Circumcision kit | |

3 Lakes Dr
Northfield IL 60093-2753 |
| For Additional Information Contact | Haley 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 | Under Investigation by firm |
| Action | Medline 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 Commerce | 640 kits |
| Distribution | US Nationwide distribution in the state of South Carolina. |
| Total Product Life Cycle | TPLC 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) Database | 510(K)s with Product Code = LRO |