Home/Recalls/FDA-Z-1845-2026
FDA DevicesClass II

Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D

Published: April 29, 2026Recall ID: Z-1845-2026Category: 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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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) LABOR PACK-22025208-LF, Model Number: DYNJ44813D

Affected Products

Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D

Additional Source Details

FieldValue
CityNorthfield
StateIL
Event id98599
Address 13 Lakes Dr
Address 2N/A
Code info1) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21CBJ477; 2) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21GBE184; 3) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21GBJ527; 4) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21HBL388; 5) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21IBT013; 6) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21LBS718; 7) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 22BBD935; 8) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 22CBA262; 9) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 22FBM910; 10) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 22LBQ838; 11) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 23FBS838; 12) DYNJ44813D, UDI... [TRUNCATED]
Postal code60093-2753
Report date20260429
Product typeDevices
Product quantity1720 units
Reason for recallThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260225
Initial firm notificationLetter
Center classification date20260417

Overview

  • Recalling FirmMedline Industries, LP
  • StatusOngoing
  • Risk LevelClass II
  • DistributionUS Nationwide distribution.
Official Agency Alert