The Recall Desk

FDA (Devices) recall action 98838

B Braun Medical Inc recalled 3 products on 2026-06-10

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2026-06-10
Critical
0
Units
702,830

Why these products were recalled

These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • SevereFDA (Devices)··2026-06-10

    Design Options spinal trays recalled over Huons bupivacaine quality issues

    Design Options spinal needle anesthesia procedure kits are being recalled because they contain Bupivacaine Hydrochloride in Dextrose Injection subject to the Huons recall.

    Product
    Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C 20061890 (560074), SSK S C H (560214), SSK BJC H S (ORIGINAL CUST) (560272), SSK CA P M C (ORIGINAL CUST) (560327), SSK T M H (560394), SSK S O 20070208 (
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  • SevereFDA (Devices)··2026-06-10

    Spinocan spinal needle kits recalled over Huons bupivacaine quality issues

    Spinocan spinal needle procedure kits are being recalled because they contain Bupivacaine Hydrochloride in Dextrose Injection subject to the Huons recall. 16,080 units affected.

    Product
    Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333201); Spinocan 25 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333211); Spin
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  • SevereFDA (Devices)··2026-06-10

    B. Braun spinal needle kits recalled over Huons bupivacaine quality issues

    Spinal needle procedure kits containing Bupivacaine Hydrochloride in Dextrose Injection are being recalled after the drug's manufacturer issued a voluntary recall. 582,030 units are affected.

    Product
    Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867); 25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862); GOVP24BK 24G PENCAN TRAY W/ BUP & DEXTROS (332607); P24BK 24G PENCAN TRAY W/BUP & DEXTROSE (333868); P
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