MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU DYNJ910835A; m
Summary
The FDA issued a Class I for MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; by Medline Industries, LP. Reason: Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in De.
Details
Source
Device Recall
External ID
Z-2748-2026
Action Date
2026-07-29
Status
Ongoing
Category
device
Product Description
MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU DYNJ910835A; medical convenience kits
Lot/Code Info: 1) Medline SKU DYNJ910835: 10198459152849 (each) 40198459152840 (case) Kit Lot Number 25BBC541; 2) Medline SKU DYNJ910835A: 10198459252570 (each) 40198459252571 (case), Kit Lot Number 25DBP805.
Quantity Affected: 56 kits
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.
Distribution
US: OH, CA, IL, IN, FL, SC, AZ, NJ.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-05
Company
Northfield, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 154 device recalls issued in the same week, part of 373 device-related FDA actions this month.
Medline Industries, LP has 511 FDA actions in our database, including 482 recalls and 29 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 511 FDA actions in our database, including 482 recalls and 29 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2748-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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