Recall archive / FDA device enforcement
MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU DYNJ910835A; med... — FDA record Z-2748-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 5, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU DYNJ910835A; medical convenience kits
- Reason
- 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.
- Classification
- Class I
- Recalling firm
- Medline Industries, LP
- Quantity
- 56 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2748-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 1) Medline SKU DYNJ910835: 10198459152849 (each) 40198459152840 (case) Kit Lot Number 25BBC541; 2) Medline SKU DYNJ910835A: 10198459252570 (each) 40198459252571 (case), Kit Lot Number 25DBP805. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: OH, CA, IL, IN, FL, SC, AZ, NJ.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 29, 2026
- Recall initiation date
- Jun 5, 2026
- Center classification date
- Jul 22, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.