Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J ; 2) UROL...
FDA Device Recall #Z-3047-2024 — Class II — April 8, 2024
Recall Summary
| Recall Number | Z-3047-2024 |
| 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 Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J ; 2) UROLOGY MINOR CDS , Pack Number CDS980371K ; 3) CIRCUMCISION TRAY 1.1 , Pack Number CIT6260A ; 4) CIRCUMCISION TRAY 1.3 CM BELL , Pack Number CIT7740; 5) CIRCUMCISION TRAY , Pack Number DYNDL1813; 6) CIRCUMCISION PACK , Pack Number DYNJ16826M ; 7) CIRCUMCISION PACK , Pack Number DYNJ16826N ; 8) CIRCUMCISION PACK , Pack Number DYNJ16826O ; 9) CIRCUMCISION PACK , Pack Number DYNJ38941D ; 10) CIRCUMCISION PACK , Pack Number DYNJ38941F ; 11) CIRCUMCISION SJHC-LF, Pack Number DYNJ48471D ; 12) CIRCUMCISION SJHC-LF, Pack Number DYNJ48471F ; 13) CRMC UNIVERSAL PACK-LF, Pack Number DYNJ61119C ; 14) D-CIRCUMCISION PACK , Pack Number DYNJ64432; 15) CIRCUMCISION PACK , Pack Number DYNJ64876A ; 16) CIRCUMCISION PACK , Pack Number DYNJ64876B ; 17) PACK,CIRCUMCISION ASC , Pack Number DYNJ906909A
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 distribution.
Lot / Code Information
CDS980371J , Lot Number 19BBJ528 ; CDS980371J , Lot Number 19BBS356 ; CDS980371J , Lot Number 19DBR965 ; CDS980371J , Lot Number 19EBX731 ; CDS980371J , Lot Number 19GBJ926 ; CDS980371J , Lot Number 19HBY831 ; CDS980371J , Lot Number 19IBL323 ; CDS980371K , Lot Number 21GBD850 ; CDS980371K , Lot Number 21HBI925 ; CDS980371K , Lot Number 21JBJ715 ; CDS980371K , Lot Number 19LBF128 ; CDS980371K , Lot Number 20BBU821 ; CDS980371K , Lot Number 20FBB764 ; CDS980371K , Lot Number 20GBR055 ; CDS980371K , Lot Number 20JBT054 ; CDS980371K , Lot Number 20LBC968 ; CDS980371K , Lot Number 21BBE923 ; CDS980371K , Lot Number 21BBG105 ; CDS980371K , Lot Number 21DBL086 ; CIT6260A , Lot Number 22LBQ691 ; CIT6260A , Lot Number 23ABQ560 ; CIT6260A , Lot Number 23EBS513 ; CIT6260A , Lot Number 23HBT731 ; CIT6260A , Lot Number 23LBT432 ; CIT7740, Lot Number 23DBE831 ; CIT7740, Lot Number 23IBR327 ; DYNDL1813, Lot Number 20FBD708 ; DYNJ16826M , Lot Number 20KME235 ; DYNJ16826M , Lot Number 20LMD829 ; DYNJ16826M , Lot Number 20LME603 ; DYNJ16826M , Lot Number 21BMD922 ; DYNJ16826M , Lot Number 21DMC310 ; DYNJ16826M , Lot Number 21GMC003 ; DYNJ16826M , Lot Number 21HMG078 ; DYNJ16826N , Lot Number 21JMF750 ; DYNJ16826N , Lot Number 21LMF895 ; DYNJ16826N , Lot Number 22CMF391 ; DYNJ16826N , Lot Number 22DMG155 ; DYNJ16826N , Lot Number 22FMB133 ; DYNJ16826N , Lot Number 22IMA881 ; DYNJ16826N , Lot Number 22KMF328 ; DYNJ16826N , Lot Number 23AMA622 ; DYNJ16826N , Lot Number 23BMG816 ; DYNJ16826N , Lot Number 23DMA339 ; DYNJ16826O , Lot Number 23FMC064 ; DYNJ16826O , Lot Number 23GMC962 ; DYNJ16826O , Lot Number 23GMG544 ; DYNJ16826O , Lot Number 23HMI663 ; DYNJ16826O , Lot Number 23JMH529 ; DYNJ16826O , Lot Number 24AMA886 ; DYNJ38941D , Lot Number 19BBN390 ; DYNJ38941D , Lot Number 19CBE691 ; DYNJ38941D , Lot Number 19EBK155 ; DYNJ38941D , Lot Number 19FBW883 ; DYNJ38941D , Lot Number 19SBF056 ; DYNJ38941D , Lot Number 19IBO888 ; DYNJ38941D , Lot Number 19KBM786 ; DYNJ38941D , Lot Number 19LBV953 ; DYNJ38941D , Lot Number 20ABG192 ; DYNJ38941D , Lot Number 20CBS685 ; DYNJ38941D , Lot Number 20EBQ929 ; DYNJ38941D , Lot Number 20GBD152 ; DYNJ38941D , Lot Number 20IMA917 ; DYNJ38941D , Lot Number 20JMA465 ; DYNJ38941D , Lot Number 21BMB204 ; DYNJ38941D , Lot Number 21CMC018 ; DYNJ38941D , Lot Number 21CMC276 ; DYNJ38941D , Lot Number 21EMB640 ; DYNJ38941D , Lot Number 21GMA293 ; DYNJ38941D , Lot Number 21HME096 ; DYNJ38941F , Lot Number 21JMF900 ; DYNJ38941F , Lot Number 21JMG634 ; DYNJ38941F , Lot Number 21LMA419 ; DYNJ38941F , Lot Number 21LMB262 ; DYNJ38941F , Lot Number 22AMC764 ; DYNJ38941F , Lot Number 22BMH048 ; DYNJ38941F , Lot Number 22DMB792 ; DYNJ38941F , Lot Number 22EMD006 ; DYNJ38941F , Lot Number 22FMG928 ; DYNJ38941F , Lot Number 22IMA224 ; DYNJ38941F , Lot Number 22KMB540 ; DYNJ38941F , Lot Number 22LMI658 ; DYNJ38941F , Lot Number 22LMI659 ; DYNJ38941F , Lot Number 23BMA793 ; DYNJ38941F , Lot Number 23BMB118 ; DYNJ48471D , Lot Number 21HBN088 ; DYNJ48471D , Lot Number 21HBN097 ; DYNJ48471D , Lot Number 21LBF729 ; DYNJ48471D , Lot Number 22BBN858 ; DYNJ48471D , Lot Number 22FBA176 ; DYNJ48471D , Lot Number 22GBM022 ; DYNJ48471D , Lot Number 22HBR350 ; DYNJ48471D , Lot Number 19HBG760 ; DYNJ48471D , Lot Number 19IBS581 ; DYNJ48471D , Lot Number 19JBH818 ; DYNJ48471D , Lot Number 23FBD447 ; DYNJ48471D , Lot Number 20KBF714 ; DYNJ48471F , Lot Number 23HBB460 ; DYNJ48471F , Lot Number 23KBH955 ; DYNJ48471F , Lot Number 23KBU382 ; DYNJ61119C , Lot Number 20IBT137 ; DYNJ61119C , Lot Number 20WBI854 ; DYNJ61119C , Lot Number 20LBH019 ; DYNJ61119C , Lot Number 21CBN114 ; DYNJ61119C , Lot Number 21FMD836 ; DYNJ61119C , Lot Number 21GME522 ; DYNJ61119C , Lot Number 21HME553 ; DYNJ61119C , Lot Number 21IMD979 ; DYNJ61119C , Lot Number 21JMA125 ; DYNJ61119C , Lot Number 21KMF555 ; DYNJ61119C , Lot Number 21LMG365 ; DYNJ64432, Lot Number 21IDA848 ; DYNJ64432, Lot Number 21KDC323 ; DYNJ64432, Lot Number 22ADA261 ; DYNJ64432, Lot Number 22CDC116 ; DYNJ64432, Lot Number 22DDC463 ; DYNJ64432, Lot Number 22GDA264 ; DYNJ64432, Lot Number 22HDB210 ; DYNJ64432, Lot Number 22JDA234 ; DYNJ64432, Lot Number 22KDA275 ; DYNJ64432, Lot Number 23BDA297 ; DYNJ64432, Lot Number 23DDC249 ; DYNJ64432, Lot Number 23FDB680 ; DYNJ64432, Lot Number 23GDB911 ; DYNJ64432, Lot Number 23IDA043 ; DYNJ64432, Lot Number 23JDC211 ; DYNJ64876A , Lot Number 21GBB289 ; DYNJ64876A , Lot Number 21HBE385 ; DYNJ64876A , Lot Number 21HBQ607 ; DYNJ64876A , Lot Number 21JBK246 ; DYNJ64876A , Lot Number 21JBU656 ; DYNJ64876A , Lot Number 21KBG007 ; DYNJ64876A , Lot Number 21LBQ521 ; DYNJ64876A , Lot Number 21LBW552 ; DYNJ64876A , Lot Number 22CBM771 ; DYNJ64876A , Lot Number 22HBK326 ; DYNJ64876A , Lot Number 22JBF576 ; DYNJ64876A , Lot Number 22KBG724 ; DYNJ64876A , Lot Number 20HBP009 ; DYNJ64876A , Lot Number 20JBD838 ; DYNJ64876A , Lot Number 20JBG527 ; DYNJ64876A , Lot Number 20JBK521 ; DYNJ64876A , Lot Number 20KBN606 ; DYNJ64876A , Lot Number 21ABW616 ; DYNJ64876A , Lot Number 21CBP857 ; DYNJ64876B , Lot Number 22LBN031 ; DYNJ64876B , Lot Number 23GBL751 ; DYNJ64876B , Lot Number 23IBP497 ; DYNJ64876B , Lot Number 23JBG687 ; DYNJ64876B , Lot Number 23KBI407 ; DYNJ64876B , Lot Number 24ABA124 ; DYNJ906909A, Lot Number 23ABE857 ; DYNJ906909A, Lot Number 23DBD597 ; DYNJ906909A, Lot Number 23DBE346 ; DYNJ906909A, Lot Number 23FBK478 ; DYNJ906909A, Lot Number 23GBI807 ; DYNJ906909A, Lot Number 23HBR596 ; DYNJ906909A, Lot Number 23IBC034 ; DYNJ906909A, Lot Number 23KBH128 ; DYNJ906909A, Lot Number 24ABT698
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.