FDA Device recall Z-2236-2026

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA1097

FDA Device
Class I
ongoing
Published 2026-06-03

On 2026-06-03 the FDA classified a Class I recall of Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA1097 by Medline Industries, citing medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2236-2026
Classification	Class I
Status	ongoing
Initiated	2026-04-10
Published	2026-06-03
Last updated	2026-09-13 11:58 UTC
Company	Medline Industries
Distribution	US

Product

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA1097; 2) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA1154; 3) SPINAL TRAY, Medline Kit SKU DYNJRA1192A; 4) BLOCK TRAY, Medline Kit SKU DYNJRA1212; 5) SPINAL NEEDLE TRAY, Medline Kit SKU DYNJRA1285; 6) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA9031; 7) SPINAL BLOCK TRAY 25G WHITACRE, Medline Kit SKU DYNJRA9032; 8) 25G SPINAL TRAY, Medline Kit SKU PAIN1239.

Reason

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.

Identifiers

code_info	Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 26BBJ392; Medline Kit SKU DYN… Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 26BBJ392; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 26ABS354; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25LBC413; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25IBK142; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25FBD584; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25BBK828; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 24FBT398; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 24BBR608; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 23JBB581; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 23IBQ010;

code_info

Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 26BBJ392; Medline Kit SKU DYN…

Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 26BBJ392; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 26ABS354; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25LBC413; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25IBK142; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25FBD584; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25BBK828; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 24FBT398; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 24BBR608; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 23JBB581; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 23IBQ010;

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2236-2026%22

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