FDA-Device2026-07-29Class IPROCESSING DEFECT

Medline surgical convenience kits recalled for quality issues in anesthetic component

OTHERNationwide distributionMedical devices

What this means

Medline Industries is recalling specific surgical convenience kits used in joint replacement procedures because they contain a pain-reliever medication (Bupivacaine Hydrochloride in Dextrose) with quality problems. The medication was manufactured by Huons Co, Ltd. and distributed through B. Braun Medical. The quality issues were identified by the supplier and no injuries have been reported.

Check if your facility received any of the affected kits by matching the SKU numbers and lot numbers listed in the recall notice
Do not use affected kits for surgical procedures
Contact Medline Industries or your supplier immediately if you have affected kits
Follow your facility's procedures for handling recalled medical devices

The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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

Affected count

2301 kits

Manufactured in

3 Lakes Dr, N/A, Northfield, IL, United States

Products

MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2) TOTAL KNEE BASIC, Medline Kit SKU DYNJ902378J; 3) TOTAL HIP, Medline Kit SKU DYNJ903492K; 4) ANTERIOR HIP, Medline Kit SKU DYNJ903493I; 5) ANTERIOR HIP, Medline Kit SKU DYNJ903493J; 6) ANTERIOR HIP, Medline Kit SKU DYNJ903493K; 7) TOTAL HIP, Medline Kit SKU DYNJ906665G; 8) TOTAL KNEE, Medline Kit SKU DYNJ906666J; 9) TOTAL HIP-LF, Medline Kit SKU DYNJ909000A; 10) TOTAL KNEE-LF, Medline Kit SKU DYNJ909002A; 11) TOTAL HIP W NAVIGATION NO SYR, Medline Kit SKU DYNJ909068B; 12) TOTAL JOINT, Medline Kit SKU DYNJ909069B; 13) TOTAL KNEE, Medline Kit SKU DYNJ909070C; 14) TOTAL KNEE W NAVIGATION NO SYR, Medline Kit SKU DYNJ909071B; 15) TOTAL KNEE W NAVIGATION, Medline Kit SKU DYNJ909071C; 16) MHCZ TOTAL KNEE, Medline Kit SKU DYNJ909534; 17) MHCZ TOTAL KNEE, Medline Kit SKU DYNJ909534A; 18) MHCZ TOTAL KNEE, Medline Kit SKU DYNJ909534B; 19) ANTERIOR HIP, Medline Kit SKU DYNJ909640F; 20) POSTERIOR HIP, Medline Kit SKU DYNJ909642D; 21) TOTAL KNEE, Medline Kit SKU DYNJ909643D; 22) TOTAL KNEE, Medline Kit SKU DYNJ909643F; 23) TOTAL JOINT, Medline Kit SKU DYNJ910002A; 24) TOTAL KNEE, Medline Kit SKU DYNJ910354A; 25) TOTAL HIP, Medline Kit SKU DYNJ910813; 26) ANTERIOR HIP, Medline Kit SKU DYNJ911083.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2749-2026

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