B. Braun Medical, Inc.
FDA adverse event reports naming B. Braun Medical, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: B. BRAUN MEDICAL, INC..
- Total reports
- 2,445
- Deaths
- 35
- Injuries
- 516
- Malfunctions
- 1,244
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Pump, InfusionFRN710
- Set, Administration, IntravascularFPA358
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ305
- Anesthesia Conduction KitCAZ275
- Catheter, Flow DirectedDYG77
- Dialyzer, High Permeability With Or Without Sealed Dialysate SystemKDI73
- Filter, Intravascular, CardiovascularDTK69
- Needle, Conduction, Anesthetic (W/Wo Introducer)BSP52
- Catheter, Angioplasty, Peripheral, TransluminalLIT48
- Catheter, Conduction, AnestheticBSO44
Recent recalls
- 2026-06-03Open, ClassifiedUnder Investigation by firm
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); P25BKAY PENCAN SPINAL TRAY (333865); P27BK PENCAN SPINAL W/BUPIVAC (333871); P25BK SPINAL TRAY (333851)
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.
- 2026-06-03Open, ClassifiedUnder Investigation by firm
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); Spinocan 22 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333231)
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.
- 2026-06-03Open, ClassifiedUnder Investigation by firm
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);
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.
- 2026-05-29Open, ClassifiedProcess control
Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software Version: N/A Product Description: CESK NORTHSIDE ANESTHESIA TRAY Component: No
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
- 2026-05-29Open, ClassifiedProcess control
Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model/Catalog Number: 570246 Software Version: N/A Product Description: BPSK, BLOCKJOCKS TRAY Component: No
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
- 2026-05-29Open, ClassifiedProcess control
Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201 Software Version: N/A Product Description: NES1725KFXL SPINAL EPID CLOSED TIP CATH Component: No
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
- 2026-05-29Open, ClassifiedProcess control
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Number: 555498 Software Version: N/A Product Description: CESK HARRIS METHODIST Component: No
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
- 2026-05-29Open, ClassifiedProcess control
Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog Number: 530184 Software Version: N/A Product Description: LYNDON B JOHNSON HOSPITAL SPINAL EPID Component: No
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
- 2026-05-29Open, ClassifiedProcess control
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number: 552126 Software Version: N/A Product Description: CESK RIVERSIDE HEALTH SYSTEM Component: No
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
- 2026-05-29Open, ClassifiedProcess control
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717 Model/Catalog Number: 555884 Software Version: N/A Product Description: CESK SHANDS JACKSONVILLE 20055717 Component: No
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
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