Medline procedural kits labeled as: 1) AFCH ANTERIOR SEGMENT PK, Pack Number DYNJ63330B ; 2)...
FDA Device Recall #Z-2765-2024 — Class II — April 8, 2024
Recall Summary
| Recall Number | Z-2765-2024 |
| 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 procedural kits labeled as: 1) AFCH ANTERIOR SEGMENT PK, Pack Number DYNJ63330B ; 2) ANTERIOR HIP PACK , Pack Number DYNJ82317; 3) ARTHROGRAM, Pack Number DYNDH1446A ; 4) ARTHROGRAM TRAY, Pack Number DYNDH1648; 5) ARTHROGRAM TRAY, Pack Number PAIN1396 ; 6) ARTHROGRAM TRAY , Pack Number DYNDH1648; 7) ARTHROGRAM TRAY , Pack Number PAIN1396 ; 8) ARTHROGRAM/ASPIRATION RADIOLOG, Pack Number DYNJRA2152 ; 9) ARTHROGRAPH TRAY, Pack Number MNS12670B; 10) ARTHROSCOPY , Pack Number DYNJ909699 ; 11) GLMI ARTHROGRAM KIT: BIG TREE , Pack Number DYNDH1752; 12) HANA TABLE, Pack Number DYNJ908424A; 13) JC HIP ARTHROSCOPY, Pack Number DYNJ907481 ; 14) JC KNEE ARTHROSCOPY , Pack Number DYNJ907480 ; 15) JC KNEE ARTHROSCOPY , Pack Number DYNJ907480A; 16) JC SHOULDER ARTHROSCOPY , Pack Number DYNJ907479A; 17) LUMBAR DRAIN PACK , Pack Number DYNJ67379; 18) LUMBAR DRAIN PACK , Pack Number DYNJ67379H ; 19) OPEN SHOULDER CDS , Pack Number CDS983316D ; 20) ORTHO SPINE PACK, Pack Number DYNJ59720A ; 21) ORTHO SPINE PACK, Pack Number DYNJ59720B ; 22) PODIATRY TRAY-LF, Pack Number DYNJ51178D ; 23) TOTAL KNEE CDS-LF , Pack Number CDS940845L ; 24) TOTAL KNEE CDS-LF , Pack Number DYNJ907028 ; 25) TOTAL KNEE CDS-LF , Pack Number DYNJ907028A; 26) TOTAL KNEE CDS-LF , Pack Number DYNJ907028C
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
DYNJ63330B , Lot Number: 23KMB339 ; DYNJ82317, Lot Number: 23JMD184 ; DYNDH1446A , Lot Number: 21LBY820 ; DYNDH1446A , Lot Number: 22GBD333 ; DYNDH1446A , Lot Number: 22JBR587 ; DYNDH1446A , Lot Number: 23FBP838 ; DYNDH1446A , Lot Number: 23GBR825 ; DYNDH1446A , Lot Number: 23HBU128 ; DYNDH1446A , Lot Number: 23IBD510 ; DYNDH1446A , Lot Number: 23JBY402 ; DYNDH1446A , Lot Number: 24ABN001 ; DYNDH1446A , Lot Number: 24BBU148 ; DYNDH1446A , Lot Number: 21BBP451 ; DYNDH1446A , Lot Number: 21BBQ361 ; DYNDH1648, Lot Number: 24CBI888 ; PAIN1396 , Lot Number: 24CMC928 ; DYNDH1648, Lot Number: 23BBU844 ; DYNDH1648, Lot Number: 23FBT610 ; DYNDH1648, Lot Number: 23KBG110 ; DYNDH1648, Lot Number: 23LBH307 ; DYNDH1648, Lot Number: 24BBQ373 ; PAIN1396 , Lot Number: 21HBQ984 ; PAIN1396 , Lot Number: 21LBQ751 ; PAIN1396 , Lot Number: 22BBY990 ; PAIN1396 , Lot Number: 22EBO906 ; PAIN1396 , Lot Number: 22GMH098 ; PAIN1396 , Lot Number: 22JMC249 ; PAIN1396 , Lot Number: 23AMC516 ; DYNJRA2152 , Lot Number: 23FBO275 ; DYNJRA2152 , Lot Number: 24BBP039 ; MNS12670B, Lot Number: 21FBO557 ; DYNJ909699 , Lot Number: 23IBG223 ; DYNJ909699 , Lot Number: 23IBI956 ; DYNDH1752, Lot Number: 22HLA308 ; DYNDH1752, Lot Number: 22KLA526 ; DYNDH1752, Lot Number: 23ELA116 ; DYNDH1752, Lot Number: 23FLA891 ; DYNDH1752, Lot Number: 23HLA148 ; DYNDH1752, Lot Number: 23JLA566 ; DYNJ908424A, Lot Number: 23IBP270 ; DYNJ907481 , Lot Number: 22CBZ144 ; DYNJ907481 , Lot Number: 22JBR781 ; DYNJ907480 , Lot Number: 21LBR978 ; DYNJ907480A, Lot Number: 22GBS401 ; DYNJ907480A, Lot Number: 22HBS464 ; DYNJ907480A, Lot Number: 22KBO665 ; DYNJ907480A, Lot Number: 22LBM801 ; DYNJ907480A, Lot Number: 23ABS425 ; DYNJ907480A, Lot Number: 23BBN787 ; DYNJ907480A, Lot Number: 23JBR354 ; DYNJ907480A, Lot Number: 24ABJ482 ; DYNJ907479A, Lot Number: 22EBM144 ; DYNJ907479A, Lot Number: 22EBN033 ; DYNJ67379, Lot Number: 22OBA461 ; DYNJ67379H , Lot Number: 22OBA461 ; CDS983316D , Lot Number: 21KBZ646 ; CDS983316D , Lot Number: 22GBK913 ; CDS983316D , Lot Number: 22JBP359 ; CDS983316D , Lot Number: 22JBQ356 ; DYNJ59720A , Lot Number: 21LBL971 ; DYNJ59720B , Lot Number: 22GBE154 ; DYNJ59720B , Lot Number: 22HBY469 ; DYNJ59720B , Lot Number: 23FBQ399 ; DYNJ59720B , Lot Number: 23IBL648 ; DYNJ51178D , Lot Number: 23IDA216 ; CDS940845L , Lot Number: 21LBG348 ; CDS940845L , Lot Number: 22GBJ055 ; CDS940845L , Lot Number: 22GBJ056 ; CDS940845L , Lot Number: 22KBH989 ; CDS940845L , Lot Number: 22KBJ721 ; CDS940845L , Lot Number: 22KBJ722 ; DYNJ907028 , Lot Number: 21KBV769 ; DYNJ907028 , Lot Number: 21LBG283 ; DYNJ907028A, Lot Number: 22HBS848 ; DYNJ907028C, Lot Number: 23BBN541 ; DYNJ907028C, Lot Number: 23CBO748 ; DYNJ907028C, Lot Number: 23GBC293 ; DYNJ907028C, Lot Number: 23IBD257 ; DYNJ907028C, Lot Number: 23IBV462
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.