Z-1918-2024Class II

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

Name: Z-1918-2024 Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-03-01
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-03-01 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PUDENDAL KIT, REF DYNJRA2210; c)... on 2024-03-01. FDA classified it as Class II and gives the reason as "Trumpet Needle Guide ring can detach when excessive pressure is applied". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1918-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-01
Posted: 2024-05-29
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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
Product code: OJH Orthopedic Tray
Reason for recall: Trumpet Needle Guide ring can detach when excessive pressure is applied.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medline issued a correction notice to its consignees on 03/01/2024 via email and USPS first class mail. The notice explained the issue and requested the consignee identify and quarantine all affected products, and respond to the notice. Once the response was received Medline would provide labels to place over the affected product in stock. If the product was further distributed the party which distributed the product was directed to notify their customers.
Quantity in commerce: 12994 units
Distribution: US Nationwide distribution.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1918-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1917-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-05	2024-05-29
Z-1918-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-05	2024-05-29

Product code OJH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)