B. Braun Medical Inc.
824 12th Ave, BETHLEHEM, PA, US
Registered product codes
43 product codes
Recent MDR events
12,266 on file
- Design Options®Jul 29, 2026Malfunction50068559
- Hemodialysis BloodlinesJul 29, 2026Malfunction2521402-2026-00755
- Hemodialysis BloodlinesJul 29, 2026Malfunction2521402-2026-00740
- Caresite Micro¿Jul 29, 2026Malfunction2521402-2026-00738
- Hemodialysis BloodlinesJul 29, 2026Malfunction2521402-2026-00739
- Infusomat®Jul 28, 2026Malfunction2521402-2026-00743
- B.BRAUNJul 28, 2026Malfunction2521402-2026-00751
- B.BRAUNJul 28, 2026Malfunction2521402-2026-00754
- Vented NeedleJul 28, 2026Malfunction2521402-2026-00734
- Infusomat®Jul 27, 2026Malfunction2521402-2026-00737
Recalls
508 on file
- Open, ClassifiedJun 3, 2026
A sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huon Co, Ltd. has issued a voluntary recall due to potential quality issues.
View FDA record ↗ - Open, ClassifiedJun 3, 2026
A sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huon Co, Ltd. has issued a voluntary recall due to potential quality issues.
View FDA record ↗ - Open, ClassifiedJun 3, 2026
A sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huon Co, Ltd. has issued a voluntary recall due to potential quality issues.
View FDA record ↗ - Open, ClassifiedMay 29, 2026
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.
View FDA record ↗ - Open, ClassifiedMay 29, 2026
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.
View FDA record ↗ - Open, ClassifiedMay 29, 2026
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.
View FDA record ↗ - Open, ClassifiedMay 29, 2026
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.
View FDA record ↗ - Open, ClassifiedMay 29, 2026
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.
View FDA record ↗ - Open, ClassifiedMay 29, 2026
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.
View FDA record ↗ - Open, ClassifiedMay 29, 2026
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.
View FDA record ↗
Compliance history
Matched by FEI 2521402.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.