Z-0448-2026Class I

Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D...

Name: Z-0448-2026 Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D...
Creator: Medline Industries, LP
Published: 2025-10-10
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-10-10 / Open, Classified / root cause: manufacturing process

FDA source

Medline Industries, LP began a recall of Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D HIP PINNING on 2025-10-10. FDA classified it as Class I and gives the reason as "Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic...". 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-0448-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-10-10
Posted: 2025-11-13
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D HIP PINNING
Product code: LRO General Surgery Tray
Reason for recall: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Safety notice was provided to customers on 10/10/2025. Follow-up "URGENT MEDICAL DEVICE RECALL" notification dated 10/21/2025 was sent out on 10/21/2025. Notification was through email and first-class mail. Customers were instructed to Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product and destroy affected kits on hand. No products are to be returned to Medline. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.com Recall Reference #: R-25-215-FG Recall Code: If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. An expanded "URGENT MEDICAL DEVICE RECALL" notification dated 10/24/2025 was provided to customers on 10/24/25, which included additional affected products. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].
Quantity in commerce: 96,406 total units
Distribution: International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI;
Product codes and lots: HIP PINNING DYNJ909308D UDI-DI 40198459055288 (case), 10198459055287 (ea) Lots 25FBB311 25GBC282 25GBW486; ORTHO SPINE ST CLAIR DYNJ901048N UDI-DI 40198459055554 (case), 10198459055553 (ea) Lots 25GBQ070; SET UP DYNJ909132F UDI-DI 40198459130572 (case), 10198459130571 (ea) Lots 25GBI845 25IBF708; UROLOGY MINOR DYNJ909123F UDI-DI 40198459130602 (case), 10198459130601 (ea) Lots 25GBT826 25IBF707

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0448-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0442-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-13
Z-0443-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-13
Z-0444-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-13
Z-0445-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-13
Z-0446-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-13
Z-0447-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-13
Z-0448-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-13
Z-0449-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-13
Z-0450-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-13
Z-0451-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-13

Product code LRO

K213481Class IIMedline General Surgery TrayMedline Industries, Inc. / cleared 2022-05-24

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)