FDA Medical devices recall ·
MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2749-2026
- 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
- 2301 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
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
Medline Kit SKU DYKS1574A, UDI/DI 10198459147449 (each) 40198459147440 (case), Kit Lot Number 25ELB079; Medline Kit SKU DYKS1574A, UDI/DI 10198459147449 (each) 40198459147440 (case), Kit Lot Number 25DLA930; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25IBN992; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25HBS205; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25DBH984; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25CBB436; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25ABR220; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 24LBI991; Medline Kit SKU DYNJ903492K, UDI/DI 10198459255199 (each) 40198459255190 (case), Kit Lot Number 25CBR847; Medline Kit SKU DYNJ903492K, UDI/DI 10198459255199 (each) 40198459255190 (case), Kit Lot Number 25CBE741; Medline Kit SKU DYNJ903493I, UDI/DI 10195327565510 (each) 40195327565511 (case), Kit Lot Number 25ADA380; Medline Kit SKU DYNJ903493I, UDI/DI 10195327565510 (each) 40195327565511 (case), Kit Lot Number 24KDA993; Medline Kit SKU DYNJ903493J, UDI/DI 10198459255052 (each) 40198459255053 (case), Kit Lot Number 25CDA748; Medline Kit SKU DYNJ903493J, UDI/DI 10198459255052 (each) 40198459255053 (case), Kit Lot Number 25CDA157; Medline Kit SKU DYNJ
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-2749-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.