FDA DeviceClass IINotable
FDA Recall: Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3
Description
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Hazard
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Remedy
513 units
Related Recalls
2026-05-06 · FDA_DEVICE
FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI
Medline Industries, LP
2026-05-06 · FDA_DEVICE
FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCE
Medline Industries, LP
2026-05-06 · FDA_DEVICE
FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS
Medline Industries, LP
2026-05-06 · FDA_DEVICE
FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF,
Medline Industries, LP