What should someone who has this product do?

Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Check the product against FDA's description (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 (additional.

Has B Braun Medical Inc had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 22 total FDA actions tied to B Braun Medical Inc, including 22 recalls and 0 warning letters.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

FDA Class I Recall: Design Options Spinal Tray Spinal Needle Anesthesia procedure… by B Braun Medical Inc

Key facts

Recalling firm	B Braun Medical Inc
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	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 (560428), SSK L G H (ORIGINAL CUST) (560462), SSK H M H (560465), SSK BUPIVACAINE TRAY 2068824 (560476), SSK K F H (560497), SSK T J U H (560513), SSK O M C (560521), SSK CUSTOM SPINAL TRAY (560523), SSK O R M C (560533), SSK B S H S 20115122 (560538), SSK M M (560572), SSK M S 27GA PENCAN SPINAL TRAY (560580), SSK S T H & C (560584), SSK U C (560587), SSK P25BKG (560603), SSK P24BKG (560606), SSK S25BKG (560607), SSK M C - BUPIVACAINE TRAY (560609), SSK T M C (560613), SSK PENCIL POINT SPINAL TRAY (560619), SSK E O & S H-SPINAL (560621), SSK BSW SPINAL TRAY (560628), SSK M C OB DEPT - SPINAL (560645), SSK B H M (560646), SSK M G M C (560647), SSK S M H (560648), SSK H H S (560660), O S U M C SPINAL TRAY SSK (560667), A M C, SSK (560670), S B H - SPINAL TRAY SSK (560672);
Classification	Class I
Recall number	Z-2278-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.

Key takeaway: B Braun Medical Inc recalled 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 (additional items listed in FDA's full record) on 2026-06-10. FDA classified this action as a Class I recall (recall number Z-2278-2026). Reason for recall: These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.. Recall status: Ongoing. This is a device-category FDA recall record.

What this classification means

FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification. In this case, the recalling firm is B Braun Medical Inc and the affected product is described in FDA's record as: 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 (additional items listed in FDA's full record). FDA's stated reason for the recall is: These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.. The recall is tracked under FDA recall number Z-2278-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome.

What consumers should do

Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Specifically, check whether the product in your possession matches the description on file with FDA -- 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 (additional items listed in FDA's full record) -- and the recall number Z-2278-2026. If it matches, stop using or distributing it and contact B Braun Medical Inc or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

B BRAUN MEDICAL INC’s FDA history

Argus HQ has recorded 22 total FDA actions tied to B BRAUN MEDICAL INC: 0 warning letters, 22 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What should someone who has this product do?: Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Check the product against FDA's description (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 (additional.
Has B Braun Medical Inc had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 22 total FDA actions tied to B Braun Medical Inc, including 22 recalls and 0 warning letters.
What is the FDA recall number for this event?: FDA recall number Z-2278-2026.
What is the current status of this recall?: Status as recorded by FDA: Ongoing.

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Full FDA history for B BRAUN MEDICAL INC

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Class I Recall: Design Options Spinal Tray Spinal Needle Anesthesia procedure… by B Braun Medical Inc — Recall Details. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-b-braun-medical-inc-z-2278-2026

MLA

"FDA Class I Recall: Design Options Spinal Tray Spinal Needle Anesthesia procedure… by B Braun Medical Inc — Recall Details." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-b-braun-medical-inc-z-2278-2026.

Chicago

Argus HQ Research. "FDA Class I Recall: Design Options Spinal Tray Spinal Needle Anesthesia procedure… by B Braun Medical Inc — Recall Details." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-b-braun-medical-inc-z-2278-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_b_braun_medical_inc_z_2278_2026_2026,
  title = {FDA Class I Recall: Design Options Spinal Tray Spinal Needle Anesthesia procedure… by B Braun Medical Inc — Recall Details},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-b-braun-medical-inc-z-2278-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗