Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED...
FDA Device Recall #Z-2442-2024 — Class I — April 8, 2024
Recall Summary
| Recall Number | Z-2442-2024 |
| Classification | Class I — Serious 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 |
| Quantity | 1,679,067 units in total |
Product Description
Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, Pack Number DYNJRA1268C; 3) WAL- UNIVERSAL BLOCK TRAY, Pack Number DYNJRA1638C; 4) BASIC DIAGNOSTIC TRAY, Pack Number DYNJRA1928; 5) PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040; 6) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA2097; 7) PAIN TRAY, Pack Number DYNJRA2230; 8) CONTINUOUS EPIDURAL, Pack Number PAIN1766A; 9) CONTINUOUS/CSE TRAY, Pack Number PAIN1856; 10) CONTINUOUS/CSE TRAY, Pack Number PAIN1856A; 11) 20G SINGLE DOSE EPIDURAL, Pack Number PAIN2047; 12) 20G SINGLE DOSE EPIDURAL/CHLOR, Pack Number PAIN2048
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: US (nationwide) and OUS countries of: AE, AI, BB, CA, CL, CY, DE, GT, HN, JP, MX, MY, PA, PE, PR, SA, SG, TC, TT, VI, PR, TT, MX, BM, ES, NI, DO, GU, CR, AT, CD, DE, DF, W, and ON.
Lot / Code Information
DYNJRA0960C , Lot Number 23CBH823 ; DYNJRA0960C , Lot Number 23EBC905 ; DYNJRA0960C , Lot Number 23EBV028 ; DYNJRA0960C , Lot Number 23HBO071 ; DYNJRA0960C , Lot Number 24BBI322 ; DYNJRA1268C , Lot Number 22GLB081 ; DYNJRA1268C , Lot Number 22HLA566 ; DYNJRA1268C , Lot Number 22ILA092 ; DYNJRA1268C , Lot Number 22LLA800 ; DYNJRA1268C , Lot Number 23DLA368 ; DYNJRA1268C , Lot Number 23FLA942 ; DYNJRA1268C , Lot Number 23GLA321 ; DYNJRA1268C , Lot Number 23HLA910 ; DYNJRA1268C , Lot Number 23ILA593 ; DYNJRA1638C , Lot Number 23EBA854 ; DYNJRA1638C , Lot Number 23GBE493 ; DYNJRA1638C , Lot Number 23KBJ159 ; DYNJRA1928 , Lot Number 22EBD354 ; DYNJRA1928 , Lot Number 22JBO947 ; DYNJRA1928 , Lot Number 23CBO440 ; DYNJRA1928 , Lot Number 23HBK783 ; DYNJRA1928 , Lot Number 23JBI435 ; DYNJRA1928 , Lot Number 23LBM602 ; DYNJRA1928 , Lot Number 24ABQ693 ; DYNJRA2040 , Lot Number 23CBH893 ; DYNJRA2040 , Lot Number 23HBX547 ; DYNJRA2040 , Lot Number 23JBN538 ; DYNJRA2040 , Lot Number 24ABQ696 ; DYNJRA2040 , Lot Number 24CBG746 ; DYNJRA2097 , Lot Number 23BBO995 ; DYNJRA2230 , Lot Number 23JBU321 ; DYNJRA2230 , Lot Number 23LBC389 ; PAIN1766A , Lot Number 23FLB123 ; PAIN1766A , Lot Number 23GLA313 ; PAIN1766A , Lot Number 24ALA302 ; PAIN1766A , Lot Number 24BLA659 ; PAIN1766A , Lot Number 24BLA888 ; PAIN1766A , Lot Number 24BLA889 ; PAIN1766A , Lot Number 24BLA998 ; PAIN1766A , Lot Number 24CLA003 ; PAIN1766A , Lot Number 24CLA078 ; PAIN1856 , Lot Number 22JLB162 ; PAIN1856 , Lot Number 22LLA409 ; PAIN1856A , Lot Number 23HLB303 ; PAIN1856A , Lot Number 24BLB005 ; PAIN1856A , Lot Number 24BLA682 ; PAIN2047 , Lot Number 24BBH932 ; PAIN2048 , Lot Number 24BBF612
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.