RecallRadar

FDA Device recall Z-1918-2024

Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832

On 2024-06-05 the FDA classified a Class II recall of Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832 by Medline Industries Northfield, citing trumpet Needle Guide ring can detach when excessive pressure is applied.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1918-2024
ClassificationClass II
Statusongoing
Initiated2024-03-01
Published2024-06-05
Last updated2026-09-13 11:57 UTC
CompanyMedline Industries Northfield
DistributionUS

Product

Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PUDENDAL KIT, REF DYNJRA2210; c) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046; d) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046H; Medical procedure convenience tray

Reason

Trumpet Needle Guide ring can detach when excessive pressure is applied.

Identifiers

code_info
a) DYNDH1832: UDI/DI 40195327330713 (case), 10195327330712 (unit), Lot Numbers: 23KBI682, 23KBT359, 23KBX629; b) DYN…a) DYNDH1832: UDI/DI 40195327330713 (case), 10195327330712 (unit), Lot Numbers: 23KBI682, 23KBT359, 23KBX629; b) DYNJRA2210: UDI/DI 40195327424047 (case), 10195327424046 (unit), Lot Numbers: 23JBX245, 23LBN930; c) DYNJRA9046: UDI/DI 40195327338610 (case), 10195327338619 (unit), Lot Numbers: 23JBX367, 23JBX368, 23JBX369, 23JBX370, 23LBA896, 23LBH751, 23LBL612, 23LBV325, 23LBV326; d) DYNJRA9046H: UDI/DI 40195327338610 (case), 10195327338619 (unit), Lot Numbers: 23JBX367, 23LBL612, 23LBV325;

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1918-2024%22

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