Recall Z-2747-2026— Medline Industries, LP
Class I · Ongoing
Class I FDA medical device recall by Medline Industries, LP, initiated 2026-06-05. It names one FDA 510(k) clearance: K213481. Product: MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G. 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..
- Recalling firm
- Medline Industries, LP
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2026-06-05
- Firm location
- Northfield, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.