FDA Medical devices recall ·
MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835 recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2748-2026
- Date
- (initiated June 5, 2026)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 56 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU DYNJ910835A; medical convenience kits
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1) Medline SKU DYNJ910835: 10198459152849 (each) 40198459152840 (case) Kit Lot Number 25BBC541; 2) Medline SKU DYNJ910835A: 10198459252570 (each) 40198459252571 (case), Kit Lot Number 25DBP805.
Distribution
US: OH, CA, IL, IN, FL, SC, AZ, NJ.
States: Arizona California Florida Illinois Indiana New Jersey Ohio South Carolina
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2748-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.