FDA DevicesClass II
Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO...
Published: April 29, 2026Recall ID: Z-1844-2026Category: devicesCountry: US
Reason for Recall / Hazard
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Product Description & Identification
Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I 3) ANGIOGRAPHY PACK, Model Number: DYNJ45234A 4) C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B 5) DR. ALLEYNE NEURO PACK, Model Number: DYNJ63779A 6) NEURO CTM IR PACK, Model Number: DYNJ87817
Affected Products
Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I 3) ANGIOGRAPHY PACK, Model Number: DYNJ45234A 4) C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B 5) DR. ALLEYNE NEURO PACK, Model Number: DYNJ63779A 6) NEURO CTM IR PACK, Model Number: DYNJ87817
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98599 |
| Address 1 | 3 Lakes Dr |
| Address 2 | N/A |
| Code info | 1) DYNJ07425, UDI-DI: 10080196866465(each), 40080196866466(case), Lot Number: 23DBP927; 2) DYNJ07425, UDI-DI: 10080196866465(each), 40080196866466(case), Lot Number: 23EBS362; 3) DYNJ38610I, UDI-DI: 10198459323102(each), 40198459323103(case), Lot Number: 25DBM593; 4) DYNJ38610I, UDI-DI: 10198459323102(each), 40198459323103(case), Lot Number: 25GBO740; 5) DYNJ45234A, UDI-DI: 10193489782554(each), 40193489782555(case), Lot Number: 23LBU617; 6) DYNJ45234A, UDI-DI: 10193489782554(each), 40193489782555(case), Lot Number: 23HBK865; 7) DYNJ53064B, UDI-DI: 10193489789164(each), 40193489789165(case), Lot Number: 24BMC721; 8) DYNJ53064B, UDI-DI: 10193489789164(each), 40193489789165(case), Lot Number: 24EMF715; 9) DYNJ53064B, UDI-DI: 10193489789164(each), 40193489789165(case), Lot Number: 24AMI140; 10) DYNJ63779A, UDI-DI: 10193489355840(each), 40193489355841(case), Lot Number: 25HBM008; 11) DYNJ87817, UDI-DI: 10198459069185(each), 40198459069186(case), Lot Number: 24HBF527; 12) DYNJ87817, UDI-DI:... [TRUNCATED] |
| Postal code | 60093-2753 |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 9645 units |
| Reason for recall | The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260225 |
| Initial firm notification | Letter |
| Center classification date | 20260417 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.