CLASS I ONGOING Device recall · Reported 29 Jul 2026 · FDA Enforcement Report

Medline Anterior Hip, Medline Kit recalled by Medline Industries

Medline Industries is recalling Medline Anterior Hip, Medline Kit, distributed in 8 states. The recall was initiated on 5 Jun 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI/DI 10198459280559 (each) 40198459280550 (case), Lot Number 25DBF430
Quantity recalled60 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2747-2026
FDA event ID
99290
Recalling firm
Medline Industries, Northfield, IL
Classification
Class I
Status
Ongoing
Recall initiated
5 Jun 2026
FDA classified
22 Jul 2026
Reported
29 Jul 2026
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Other Reasons

Timeline

5 Jun 2026Recall initiated by company
22 Jul 2026Classified by FDA+47 days
29 Jul 2026Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G

Where it was distributed

US: OH, CA, IL, IN, FL, SC, AZ, NJ.

ArizonaCaliforniaFloridaIllinoisIndianaNew JerseyOhioSouth Carolina

Questions about this recall

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.

Which lots are affected?

UDI/DI 10198459280559 (each) 40198459280550 (case), Lot Number 25DBF430

Where was it sold?

US: OH, CA, IL, IN, FL, SC, AZ, NJ.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 99290

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