Class I U.S. Food and Drug Administration

Medline convenience kits labeled as: 1) Total Joint KIT recall: Medline Industries, LP is issuing a recall for specific Medline kits

Recall published 3 months ago

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.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2749-2026
Published
July 29, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
2301 kits
Distribution
Arizona, California, Florida, Illinois, Indiana, New Jersey, Ohio, South Carolina
Made in
United States
Lot / code info
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 DYNJ903493K, UDI/DI 10198459293122 (each) 40198459293123 (case), Kit Lot Number 25DDA444; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 25GDA109; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 25FDB471; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 25EDB817; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 25BDA465; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 24LDB209; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 24LDA032; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 24KDB063; Medline Kit SKU DYNJ906666J, UDI/DI 10195327129590 (each) 40195327129591 (case), Kit Lot Number 25ABU735; Medline Kit SKU DYNJ906666J, UDI/DI 10195327129590 (each) 40195327129591 (case), Kit Lot Number 24LBU076; Medline Kit SKU DYNJ909000A, UDI/DI 10195327428327 (each) 40195327428328 (case), Kit Lot Number 25EBN666; Medline Kit SKU DYNJ909000A, UDI/DI 10195327428327 (each) 40195327428328 (case), Kit Lot Number 25DBF470; Medline Kit SKU DYNJ909000A, UDI/DI 10195327428327 (each) 40195327428328 (case), Kit Lot Number 25CBA048; Medline Kit SKU DYNJ909002A, UDI/DI 10195327428334 (each) 40195327428335 (case), Kit Lot Number 25FBH718; Medline Kit SKU DYNJ909002A, UDI/DI 10195327428334 (each) 40195327428335 (case), Kit Lot Number 25EBF688; Medline Kit SKU DYNJ909002A, UDI/DI 10195327428334 (each) 40195327428335 (case), Kit Lot Number 25DBO198; Medline Kit SKU DYNJ909002A, UDI/DI 10195327428334 (each) 40195327428335 (case), Kit Lot Number 25ABL694; Medline Kit SKU DYNJ909002A, UDI/DI 10195327428334 (each) 40195327428335 (case), Kit Lot Number 24KBU683; Medline Kit SKU DYNJ909068B, UDI/DI 10198459077364 (each) 40198459077365 (case), Kit Lot Number 25ABI346; Medline Kit SKU DYNJ909068B, UDI/DI 10198459077364 (each) 40198459077365 (case), Kit Lot Number 24LBR150; Medline Kit SKU DYNJ909068B, UDI/DI 10198459077364 (each) 40198459077365 (case), Kit Lot Number 24LBD242; Medline Kit SKU DYNJ909069B, UDI/DI 10198459248375 (each) 40198459248376 (case), Kit Lot Number 25EBM976; Medline Kit SKU DYNJ909069B, UDI/DI 10198459248375 (each) 40198459248376 (case), Kit Lot Number 25CBJ024; Medline Kit SKU DYNJ909069B, UDI/DI 10198459248375 (each) 40198459248376 (case), …
UPC codes
10198459147449, 40198459147440, 10198459128813, 40198459128814, 10198459255199, 40198459255190, 10195327565510, 40195327565511, 10198459255052, 40198459255053, 10198459293122, 40198459293123, 10195327092481, 40195327092482, 10195327129590, 40195327129591, 10195327428327, 40195327428328, 10195327428334, 40195327428335

Products covered by this recall

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.

Check your product

The notice names 60 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10198459147449
  • 40198459147440
  • 10198459128813
  • 40198459128814
  • 10198459255199
  • 40198459255190
  • 10195327565510
  • 40195327565511
  • 10198459255052
  • 40198459255053
  • 10198459293122
  • 40198459293123
  • 10195327092481
  • 40195327092482
  • 10195327129590
  • 40195327129591
  • 10195327428327
  • 40195327428328
  • 10195327428334
  • 40195327428335

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 25ELB079
  • 25DLA930
  • 25IBN992
  • 25HBS205
  • 25DBH984
  • 25CBB436
  • 25ABR220
  • 24LBI991
  • 25CBR847
  • 25CBE741
  • 25ADA380
  • 24KDA993
  • 25CDA748
  • 25CDA157
  • 25DDA444
  • 25GDA109
  • 25FDB471
  • 25EDB817
  • 25BDA465
  • 24LDB209

Model or item number

On the rating label, the box or the instruction sheet.

  • DYKS1574A
  • DYNJ902378J
  • DYNJ903492K
  • DYNJ903493I
  • DYNJ903493J
  • DYNJ903493K
  • DYNJ906665G
  • DYNJ906666J
  • DYNJ909000A
  • DYNJ909002A
  • DYNJ909068B
  • DYNJ909069B
  • DYNJ909070C
  • DYNJ909071B
  • DYNJ909071C
  • DYNJ909534
  • DYNJ909534A
  • DYNJ909534B
  • DYNJ909640F
  • DYNJ909642D

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medline Industries, LP — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices 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. Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10198459147449, 40198459147440, 10198459128813; lot code 25ELB079, 25DLA930, 25IBN992; model number DYKS1574A, DYNJ902378J, DYNJ903492K. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Which states were affected?

The notice lists Arizona, California, Florida, Illinois, Indiana, New Jersey, Ohio, South Carolina.

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