Brand

B Braun Medical Inc

147 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for B Braun Medical Inc and translate it into plain English — free weekly digest, optional same-day alerts.

2025-12-03FDA-DeviceClass II
ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. PB602VSL NON-VENT SET 103-IN-DR; Catalog Number: 352062.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-12-03FDA-DeviceClass II
ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. V1782F UNIV IV SET W/0.2 MICRON FILTER; Catalog Number: 352447.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-12-03FDA-DeviceClass II
ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. Primary Gravity IV Set, 2 Non-Needle-Free Injection Sites; Catalog Number: V1443. 2. ADDITIVE SET W/ 3 INJ SITES -DR*; Catalog Number: V1447. 3. ADD PEDIATRIC 3 INJ LUER LOCK; Catalog Number: V1448. 4. ADULT ADD 2 INJ CKV LUER LOCK; Catalog Number: V1
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29FDA-DeviceClass I
Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A
The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.
2025-10-15FDA-DeviceClass II
Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: 1. CESK ROBERT WOOD JOHNSON UNIV HOSP. 2. CESK EAST JEFFERSON GEN HOSP 20071769. 3. CESK FLETCHER ALLEN HOSPITAL. 4. CESK WASHOE MEDICAL CENTER. 5. CESK DETROIT MEDICAL CTR 20064586. 6. CESK ALBANY MEDICAL CENTER. 7. CESK EPIDURAL BLOCK TRAY. 8. CESK, BSW EPIDURAL TRAY. 9. CESK HOWARD COUNTY GENERAL. 10. CESK CE17TKFC10L. 11. CESK WILLIAMSON MEDICAL CENTER.
Potential for the lid of the catheter connector to be in the incorrect position.
2025-10-15FDA-DeviceClass II
Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Product Code: SESK. Product Description: SESK COMBINED SPINAL AND EPIDURAL TRAY 2.
Potential for the lid of the catheter connector to be in the incorrect position.
2025-10-15FDA-DeviceClass II
Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY. 2. SESK OWENSBORO DAVIESS HOSP 20058814. 3. SESK MEMORIAL HEALTH SYSTEM SPINAL/EPID. 4. SESK ST. JOHN'S MERCY MED CTR SPINAL/EPID. 5. SESK MAIMONIDES HOSPITAL SPINAL/EPIDURAL. 6. SESK OU MEDICAL CENTER - SPINAL/EPIDURAL. 7. SESK ELLIS HOSPITAL - SPINAL EPIDURAL. 8. STONY BROOK HSP SPINAL EPIDRAL TRAY SESK. 9. SESK UAB SPINAL EPIDURAL. 10. SESK CREI
Potential for the lid of the catheter connector to be in the incorrect position.
2025-10-15FDA-DeviceClass II
Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle and 19 Ga. Open Tip PERIFIX FX Springwound Epidural Catheter. Product Code: NES1727KFX. Product Description: NES1727KFX W /17GA TUOHY 19GA SPRW OT.
Potential for the lid of the catheter connector to be in the incorrect position.
2025-10-15FDA-DeviceClass II
ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 25 Ga. x 5 in. (12.7 cm) Spinal Needle with Marking and Centering Sleeve, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Product Code: ES1725KFX. Product Description: ES1725KFX ESPOCAN SPINAL/EPID. TRAY.
Potential for the lid of the catheter connector to be in the incorrect position.
2025-10-15FDA-DeviceClass II
PERIFIX FX Continuous Epidural Anesthesia Set, PERIFIX Tuohy Epidural Needle - 17 Ga. x 3-1/2 in. (8.9 cm) - Winged, PERIFIX FX Springwound Epidural Catheter - 19 Ga. Closed tip. Product Code: CE17TFC. Product Description: CE17TFC CONTINUOUS EPID SET W/17G TUOHY.
Potential for the lid of the catheter connector to be in the incorrect position.
2025-10-15FDA-DeviceClass II
PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFS. Product Description: CE17TKFS EPIDURAL TRAY.
Potential for the lid of the catheter connector to be in the incorrect position.
2025-10-15FDA-DeviceClass II
PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFCS. Product Description: CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF.
Potential for the lid of the catheter connector to be in the incorrect position.
2025-10-15FDA-DeviceClass II
PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFSDT. Product Description: CE17TKFSDT EPID TRAY W/17GA FIXED WING.
Potential for the lid of the catheter connector to be in the incorrect position.
2025-10-15FDA-DeviceClass II
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKF. Product Description: CE17TKF PERIFIX CONTIN. EPIDURAL TRAY
Potential for the lid of the catheter connector to be in the incorrect position.
2025-10-15FDA-DeviceClass II
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFC. Product Description: CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY.
Potential for the lid of the catheter connector to be in the incorrect position.
2025-10-15FDA-DeviceClass II
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFCPS. Product Description: CE17TKFCPS EPIDURAL FULL TRAY.
Potential for the lid of the catheter connector to be in the incorrect position.
2025-10-15FDA-DeviceClass II
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and PERIFIX FX Springwound Catheter - 19 Ga. Closed Tip. Product Code: CE17TBFC. Product description: CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY.
Potential for the lid of the catheter connector to be in the incorrect position.
2025-09-24FDA-DrugClass II
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
2025-09-24FDA-DrugClass II
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
2025-09-10FDA-DrugClass I
0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09
Presence of Particulate Matter.
2025-09-10FDA-DrugClass I
Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07
Presence of Particulate Matter
2025-08-20FDA-DrugClass II
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
2025-08-20FDA-DrugClass II
Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00.
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
2025-08-13FDA-DeviceClass I
Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air vent, which is common to air eliminating filters.
2025-07-02FDA-DrugClass II
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
2025-04-16FDA-DrugClass II
0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10
Presence of Particulate Matter
2025-03-26FDA-DeviceClass II
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
Increased risk for valve housing detachment causing leakage.

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