BD recalled 3,550 spinal anesthesia trays over a supplier's GMP-failed bupivacaine

On April 27, 2026, Becton Dickinson initiated a recall of its BDSpinal Tray with BDWhitacre Needle kits — anesthesia trays containing lidocaine and bupivacaine ampules — after supplier Huons Co., Ltd. recalled its Bupivacaine Hydrochloride in Dextrose Injection. The FDA classified the action Class I and posted it on May 29, 2026: the recall was a sub-recall of Huons' own product recall, driven by quality deficiencies the FDA identified during a manufacturing facility inspection of Huons, specifically in acceptance testing.

The scope was 3,550 units distributed nationwide across 38 states, the District of Columbia listing and Puerto Rico. BD notified consignees by FedEx letter, instructing customers to stop using the affected bupivacaine ampules, remove and destroy them from opened trays, and secure an alternative local bupivacaine supply before procedures. Distributors were told to identify all affected inventory and pass the notice down their networks; a customer response form was required even from customers holding no affected product.

The FDA had placed Huons-made bupivacaine on Import Alert 66-40 — detention without physical examination for firms that have not met drug GMPs. BD ceased manufacturing kits and trays containing the Huons ampules and issued an updated consignee notice on July 8, 2026 clarifying the recall. No injuries are mentioned in the recall record; the cause code is nonconforming material or component.

Class I recall Z-2252-2026 of 3,550 trays distributed nationwide; customers told to destroy the affected ampules and secure alternative bupivacaine before procedures

BD built its trays around a single outsourced anesthetic whose maker failed the FDA's GMP inspection, so the supplier's quality lapse translated directly into a Class I action on BD's product.

The failure was in acceptance testing — the very check meant to catch bad incoming components — which meant the trays shipped with ampules that should have been rejected.

As the finished-device maker, BD owned the field action even though the defect originated upstream at Huons.

A Class I recall can start in someone else's factory: when a critical component is a drug, your supplier's GMP record is part of your product's safety case.

The recall is open and classified; BD stopped producing trays with the Huons ampules and clarified instructions to consignees on July 8, 2026. Huons-made bupivacaine remains subject to FDA Import Alert 66-40, with Huons' own product recall requesting quarantine of all ampules within expiry. No adverse events are recorded in the material.