Class I U.S. Food and Drug Administration

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose recall: Medline kits were distributed containing Huons Bupivacaine Hydrochloride

Recall published 5 months ago

Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.

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-2232-2026
Published
June 3, 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
28106 kits
Distribution
Nationwide
Made in
United States
Lot / code info
Medline SKU DYNJRA1555: UDI/DI 10193489238723 each, 40193489238724 case, Lot Numbers: 25CLA724; Medline SKU DYNJRA1555: UDI/DI 10193489238723 each, 40193489238724 case, Lot Numbers: 25CLA306; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25JMH667; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25JMC856; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25JMA370; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25IMI402; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25HME985; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25AMI063; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 24JMI488; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 24JMA113; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 23KMD776; Medline SKU DYNJRA1920: UDI/DI 10195327111168 each, 40195327111169 case, Lot Numbers: 25FBQ144; Medline SKU DYNJRA2013: UDI/DI 10195327212049 each, 40195327212040 case, Lot Numbers: 26ABV382; Medline SKU DYNJRA2013: UDI/DI 10195327212049 each, 40195327212040 case, Lot Numbers: 24GBA206; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 26BMJ305; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 25LMA710; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 25JMI170; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 25JMA642; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 25GMH968; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 25EMJ739; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 25DMF107; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 25DMB676; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 24HMD119; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 24DMB563; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 23IBL595; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 23GBO103; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 25EMJ740; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 25EMB776; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 25DMH562; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 25DMD631; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 24JMA116; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 24FMI984; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 24EMC757; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 24CMH743; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 24BBP785; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 23HBQ128; Medline SKU DYNJRA2067A: UDI/DI 10198459371967 each, 40198459371968 case, Lot Numbers: 26BBJ400; Medline SKU DYNJRA2093: UDI/DI 10195327296797 each, 40195327296798 case, Lot Numbers: 23JBQ988; Medline SKU DYNJRA2117A: UDI/DI 10198459009273 each, 40198459009274 case, Lot Numbers: 26BMC993; Medline SKU DYNJRA2117A: UDI/DI 10198459009273 each, 40198459009274 case, Lot Numbers: 26AMF175; Medline SKU DYNJRA2117A: UDI/DI 10198459009273 each, 40198459009274 case, Lot Numbers: 25LMG019; Medline SKU DYNJRA2117A: UDI/DI 10198459009273 each, 401984…
UPC codes
10193489238723, 40193489238724, 10193489942354, 40193489942355, 10195327111168, 40195327111169, 10195327212049, 40195327212040, 10195327217402, 40195327217403, 10195327269142, 40195327269143, 10198459371967, 40198459371968, 10195327296797, 40195327296798, 10198459009273, 40198459009274

Products covered by this recall

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) PAIN TRAY, Medline Kit SKU DYNJRA1555; 2) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA1817; 3) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA1920; 4) ULTRASOUND GUIDED NERVE BLOCK, Medline Kit SKU DYNJRA2013; 5) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2017; 6) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2067; 7) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2067A; 8) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2093; 9) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2117A; 10) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2124; 11) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2124A; 12) PAIN TRAY, Medline Kit SKU DYNJRA2144; 13) TRAY, 24G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2221; 14) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2333; 15) SPINAL TRAY, Medline Kit SKU DYNJRA2390; 16) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2402; 17) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407; 18) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407A; 19) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407B; 20) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2447; 21) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2447A; 22) SPINAL TRAY 25G, Medline Kit SKU DYNJRA2488A; 23) J&S SPINAL TRAY, Medline Kit SKU DYNJRA2545; 24) SPINAL TRAY, Medline Kit SKU DYNJRA2549; 25) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2550; 26) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2552; 27) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2554; 28) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2554A; 29) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2578; 30) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2588; 31) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2602; 32) SPINAL TRAY, Medline Kit SKU DYNJRA2618; 33) SPINAL TRAY, Medline Kit SKU DYNJRA2619; 34) SPINAL TRAY, Medline Kit SKU DYNJRA2622; 35) SPINAL BLOCK 25 WHITACRE 5S ND, Medline Kit SKU DYNJRA2624; 36) SPINAL TRAY, Medline Kit SKU DYNJRA2631; 37) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2632; 38) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2633; 39) SPINAL TRAY, Medline Kit SKU DYNJRA2645; 40) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2654; 41) CSE PAIN MANAGEMENT TRAY, Medline Kit SKU DYNJRA2665; 42) SPINAL TRAY, Medline Kit SKU DYNJRA2667; 43) SPINAL TRAY 24G BD, Medline Kit SKU DYNJRA2675; 44) SPINAL TRAY W/ CHLORAPREP, Medline Kit SKU DYNJRA2680; 45) SPINAL TRAY, Medline Kit SKU DYNJRA2682; 46) TRAY, 24G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2684; 47) SPINAL TRAY, Medline Kit SKU DYNJRA2725; 48) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2757; 49) TRAY, 25G SPINAL W/RX DURAPREP, Medline Kit SKU DYNJRA9039; 50) TRAY, 25G SPINAL W/RX, Medline Kit SKU DYNJRA9045; 51) SLSYSTEM CSE TRAY, Medline Kit SKU PAIN2333; 52) 25G SPINAL BLOCK TRAY, Medline Kit SKU SAMPA0135.

Check your product

The notice names 58 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.

  • 10193489238723
  • 40193489238724
  • 10193489942354
  • 40193489942355
  • 10195327111168
  • 40195327111169
  • 10195327212049
  • 40195327212040
  • 10195327217402
  • 40195327217403
  • 10195327269142
  • 40195327269143
  • 10198459371967
  • 40198459371968
  • 10195327296797
  • 40195327296798
  • 10198459009273
  • 40198459009274

Lot or batch code

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

  • 25CLA724
  • 25CLA306
  • 25JMH667
  • 25JMC856
  • 25JMA370
  • 25IMI402
  • 25HME985
  • 25AMI063
  • 24JMI488
  • 24JMA113
  • 23KMD776
  • 25FBQ144
  • 26ABV382
  • 24GBA206
  • 26BMJ305
  • 25LMA710
  • 25JMI170
  • 25JMA642
  • 25GMH968
  • 25EMJ739

Model or item number

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

  • DYNJRA1555
  • DYNJRA1817
  • DYNJRA1920
  • DYNJRA2013
  • DYNJRA2017
  • DYNJRA2067
  • DYNJRA2067A
  • DYNJRA2093
  • DYNJRA2117A
  • DYNJRA2124
  • DYNJRA2124A
  • DYNJRA2144
  • DYNJRA2221
  • DYNJRA2333
  • DYNJRA2390
  • DYNJRA2402
  • DYNJRA2407
  • DYNJRA2407A
  • DYNJRA2407B
  • DYNJRA2447

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 — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

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 kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10193489238723, 40193489238724, 10193489942354; lot code 25CLA724, 25CLA306, 25JMH667; model number DYNJRA1555, DYNJRA1817, DYNJRA1920. 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?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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