Z-2593-2025Class I

Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B

Name: Z-2593-2025 Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
Creator: Medline Industries, LP
Published: 2025-08-08
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-08-08 / Open, Classified / root cause: manufacturing process

FDA source

Medline Industries, LP began a recall of Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B on 2025-08-08. FDA classified it as Class I and gives the reason as "Convenience kits labeled as sterile have not gone through the sterilization process". 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-2593-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-08-08
Posted: 2025-09-26
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
Product code: OJH Orthopedic Tray
Reason for recall: Convenience kits labeled as sterile have not gone through the sterilization process.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Customers were alerted via email and telephone beginning 8/8/25 of a potential issue with the products. An URGENT MEDICAL DEVICE RECALL notification letter dated 8/22/25 was sent to customers. This communication is a follow-up to the notification you received from your Medline Sales Representative and to acknowledge the subsequent return of impacted product to Medline. This communication is to provide formal documentation of the recall for your records. No additional action is required to be taken. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Sterile Medline Convenience Kits. It has been identified that specific convenience kits labeled as sterile have not gone through the sterilization process. As a result, these kits are non-sterile. If the non-sterile kits are assumed sterile upon use, this could result in potential contamination of the sterile-field and an increased risk of patient infection that may require the use of intravenous or oral antibiotics. Refer to the enclosed list for all affected item number(s) and affected lot number(s). Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax and to Medline Industries, LP. If you have any questions regarding this notification, please contact the Director, Regulatory Compliance at ([email protected]). or Product Recall Specialist at [email protected].
Quantity in commerce: 88 units
Distribution: US Distribution to States of: FL, MD, NJ, TN
Product codes and lots: 1) DYNJ45701B, UDI-DI: 10193489856279(each), 40193489856270(case), Lot Number: 25GBF686

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2593-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2592-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-09-26
Z-2593-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-09-26

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)