Z-2748-2026Class I

MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU...

Name: Z-2748-2026 MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU...
Creator: Medline Industries, LP
Published: 2026-06-05
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-06-05 / Open, Classified / root cause: supplier

FDA source

Medline Industries, LP began a recall of MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU DYNJ910835A; medical convenience kits on 2026-06-05. FDA classified it as Class I and gives the reason as "Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-2748-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-06-05
Posted: 2026-07-22
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU DYNJ910835A; medical convenience kits
Product code: OHM Cesarean Section Tray
Reason for recall: Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.
Root cause tag: supplier
FDA root cause: Under Investigation by firm
Action: Medline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 6/5/2026 via USPS and email. The notice explained the issue, potential risk to health, and requested the following: identify and quarantine product, and complete response and return the response form using the Website link: https://recalls.medline.com. Those who further distributed the affected product have been directed to notify their customers. Upon receipt of the submitted response form, the consignee will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. For questions, contact the Recall Department at 866-359-1704 or [email protected].
Quantity in commerce: 56 kits
Distribution: US: OH, CA, IL, IN, FL, SC, AZ, NJ.
Product codes and lots: 1) Medline SKU DYNJ910835: 10198459152849 (each) 40198459152840 (case) Kit Lot Number 25BBC541; 2) Medline SKU DYNJ910835A: 10198459252570 (each) 40198459252571 (case), Kit Lot Number 25DBP805.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2748-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2747-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-22
Z-2748-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-22
Z-2749-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-22

Product code OHM

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)