Medline Procedure kits labeled as: 1) CIRCUMCISION SET, Pack Number CIT6335; 2) CIRCUMCISION...
FDA Device Recall #Z-2761-2024 — Class II — April 8, 2024
Recall Summary
| Recall Number | Z-2761-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 8, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
Product Description
Medline Procedure kits labeled as: 1) CIRCUMCISION SET, Pack Number CIT6335; 2) CIRCUMCISION TRAY , Pack Number CIT6135BH; 3) CIRCUMCISION TRAY , Pack Number CIT2465; 4) CIRCUMCISION TRAY , Pack Number CIT4920; 5) CIRCUMCISION TRAY , Pack Number CIT7455; 6) CIRCUMCISION TRAY , Pack Number DYNDA3045; 7) CIRCUMCISION TRAY , Pack Number DYNDL1889; 8) CIRCUMCISION TRAY , Pack Number CIT7455H ; 9) CIRCUMCISION TRAY W/1.3 CLAMP , Pack Number CIT6075; 10) CIRCUMCISON TRAY, Pack Number CIT7380; 11) HOSPITAL CIRCUMCISION T, Pack Number CIT2825; 12) CIRCUMCISION TRAY , Pack Number CIT6135A ; 13) CIRCUMCISION TRAY , Pack Number CIT6135B ; 14) NICU CIRCUMCISION SET, Pack Number CIT6900;
Reason for Recall
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Distribution Pattern
Worldwide
Lot / Code Information
CIT6335, Lot Number 22IBT528 ; CIT6135BH, Lot Number 22OBI417 ; CIT6135BH, Lot Number 22FBX794 ; CIT6135BH, Lot Number 23CBQ475 ; CIT6135BH, Lot Number 23CBT677 ; CIT6135BH, Lot Number 23EBP345 ; CIT6135BH, Lot Number 23LBI785 ; CIT6135BH, Lot Number 24BBT038 ; CIT2465, Lot Number 21BBH212 ; CIT4920, Lot Number 22GBS036 ; CIT4920, Lot Number 22IBF469 ; CIT4920, Lot Number 23CBG366 ; CIT4920, Lot Number 23IBL492 ; CIT7455, Lot Number 23GBV732 ; DYNDA3045, Lot Number 23FBO420 ; DYNDA3045, Lot Number 23GBI869 ; DYNDA3045, Lot Number 23IBR354 ; DYNDL1889, Lot Number 23GLB117 ; DYNDL1889, Lot Number 23ILA455 ; CIT7455H , Lot Number 23GBV732 ; CIT6075, Lot Number 22DBD285 ; CIT6075, Lot Number 22EBV624 ; CIT6075, Lot Number 23ABM531 ; CIT6075, Lot Number 23CBC554 ; CIT6075, Lot Number 23CBH405 ; CIT6075, Lot Number 23EBC481 ; CIT6075, Lot Number 23EBS480 ; CIT6075, Lot Number 23FBT595 ; CIT6075, Lot Number 23IBT726 ; CIT7380, Lot Number 22GBM440 ; CIT7380, Lot Number 24BBM689 ; CIT2825, Lot Number 22JBI550 ; CIT2825, Lot Number 23BBR929 ; CIT2825, Lot Number 23GBD786 ; CIT2825, Lot Number 23IBL941 ; CIT6135A , Lot Number 21CBG443 ; CIT6135A , Lot Number 21CBG766 ; CIT6135B , Lot Number 22OBI417 ; CIT6135B , Lot Number 22FBX794 ; CIT6135B , Lot Number 23CBQ475 ; CIT6135B , Lot Number 23CBT677 ; CIT6135B , Lot Number 23EBP345 ; CIT6135B , Lot Number 23LBI785 ; CIT6135B , Lot Number 24BBT038 ; CIT6900, Lot Number 21LBB097 ; CIT6900, Lot Number 22GBF169 ; CIT6900, Lot Number 22IBR336 ; CIT6900, Lot Number 23DBE643
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.