Medline Circumcision Kits Recalled Due to Defective Syringes
Medline is recalling two circumcision tray kit models due to plastic syringes with leaks, breakage, and quality defects that may harm patients. The kits have been distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall affecting medical devices used in invasive surgical procedures. While no illnesses or injuries have been reported, the identified quality issues (leaks and breakage) in surgical syringes represent a risk of harm to patients, meeting the criteria for a high-severity recall.
Plain-English summary
Medline Industries is recalling two models of surgical circumcision kits: the Medical Circumcision Tray (Pack CIT6780, Lot 2022072650) and the NICU Circumcision Tray Without Clamp (Pack CIT6920, Lot 2023101290). The kits contain plastic syringes affected by an FDA Safety Alert issued March 19, 2024.
The syringes in these kits have been identified with quality issues including leaks, breakage, and other defects. These problems may pose a risk to patient health during circumcision procedures.
The recalled kits have been distributed worldwide. Healthcare facilities and surgical centers that use these specific kit models and lot numbers should verify their inventory and take appropriate action.
The recalled product
- Product
- Medline procedural kits labeled as: 1) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- CIT6780
- Lot Number 2022072650
- CIT6920
- Lot Number 2023101290
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 27 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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