A quality problem flagged by a single drug manufacturer has rippled outward into the operating room. B. Braun Medical is recalling 686,750 prefilled spinal anesthesia trays across the United States after Huons Co., Ltd. — the maker of the bupivacaine hydrochloride in dextrose injection packaged inside them — issued a voluntary recall of the drug for what FDA records describe as “potential quality issues.”
The action is split across two device recall records, both initiated May 6, 2026 and classified by the FDA on June 3 as Class 2, the agency’s tier for products that may cause temporary or medically reversible harm. The larger record, Z-2276-2026, covers 582,030 units across seven Pencan spinal-tray variants in 24-, 25-, and 27-gauge configurations, two of them packaged with DuraPrep skin prep. A companion record, Z-2278-2026, covers 104,720 units of B. Braun’s customizable Design Options Spinal Tray, spanning 35 hospital-specific material variants. Both carry the same FDA product code, OFU, and both were distributed nationwide.
A drug recall in a device’s clothing
The FDA filings are explicit that these are “sub-recalls”: B. Braun is pulling the trays not because of a fault in the kit itself, but because the bundled bupivacaine is implicated in Huons’ upstream action.
“A sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP.”
The root cause remains listed as “under investigation by firm,” and the records do not specify the nature of the defect. Bupivacaine is the standard local anesthetic for spinal blocks in cesarean delivery and lower-body surgery, making the affected trays a routine stock item in many hospital anesthesia carts.