The Recall Desk

Manufacturer

B Braun Medical Inc

173 recalls in our database name B Braun Medical Inc as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 173

  • SevereFDA (Drugs)·D-0540-2026·2026-05-13

    Lactated Ringers Injection Recalled for Particulate Matter Contamination

    B. Braun Medical Inc. is recalling Lactated Ringer's Injection USP (1000 mL containers) due to the presence of particulate matter. The recall affects 95,412 containers distributed nationwide.

    Product
    LACTATED RINGERS — LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0496-2026·2026-04-29

    Dextrose Injection USP recalled due to sterility assurance concerns

    B. Braun Medical Inc. is recalling Dextrose Injection USP 70% in 2000 mL bags nationwide due to lack of assurance of sterility and potential leakage from the diaphragm port after foil removal.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0495-2026·2026-04-29

    Sterile Water for Injection bags recalled due to sterility concerns

    B. Braun Medical Inc. is recalling Sterile Water for Injection USP 3000 mL bags (24,928 units) distributed nationwide due to lack of assurance of sterility and potential leakage from the diaphragm port.

    Product
    STERILE WATER — STERILE WATER (WATER)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0497-2026·2026-04-29

    Sodium Chloride for Irrigation Lacks Sterility Assurance

    B. Braun Medical Inc. is recalling sodium chloride for irrigation solution (3000 mL bags) due to lack of assurance of sterility and potential leakage from the diaphragm port. Affected lots distributed nationwide have expiration dates through May 31, 2028.

    Product
    SODIUM CHLORIDE FOR IRRIGATION — SODIUM CHLORIDE FOR IRRIGATION (SODIUM CHLORIDE FOR IRRIGATION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0498-2026·2026-04-29

    Lactated Ringers Irrigation 3000 mL Bags Recall: Sterility Concern

    B. Braun Medical Inc. is recalling Lactated Ringers Irrigation 3000 mL bags due to lack of assurance of sterility and potential leakage from the diaphragm port after foil removal.

    Product
    LACTATED RINGERS IRRIGATION — LACTATED RINGERS IRRIGATION (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1800-2026·2026-04-22

    B. Braun Hemodialysis Bloodlines Recalled for Air Bubble Risk

    B. Braun Hemodialysis Bloodlines may accumulate small air bubbles in the arterial line due to blood gases adhering to tubing under negative pressure. Approximately 1.17 million units have been recalled in this Class I FDA action.

    Product
    B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1803-2026·2026-04-22

    B Braun Hemodialysis Bloodlines Recalled for Air Bubble Accumulation

    B Braun is recalling hemodialysis bloodlines (Model B3-4630M4705, 4,884 units) due to potential air bubble accumulation in the arterial line. Units manufactured since August 5, 2025 are affected and were distributed in the US and Canada.

    Product
    B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1798-2026·2026-04-22

    B. Braun Hemodialysis Bloodlines Recalled for Potential Air Bubble Accumulation

    B. Braun is recalling STREAMLINE BLOODLINE SET hemodialysis devices due to potential air bubble accumulation in the arterial line. The recall affects 3,158,104 units.

    Product
    B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1801-2026·2026-04-22

    B. Braun Hemodialysis Bloodlines Recalled for Potential Air Bubble Accumulation

    B. Braun is recalling hemodialysis bloodlines (Model SL-2000M2095L) due to potential air bubble accumulation in the arterial line under negative pressure. Approximately 328,640 units distributed worldwide are affected.

    Product
    B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1799-2026·2026-04-22

    B. Braun Hemodialysis Bloodlines Recalled for Potential Air Bubble Risk

    B. Braun Medical is recalling hemodialysis bloodline sets due to potential air bubble accumulation in the arterial line. This Class I recall affects model SL-2010M2096 manufactured since May 25, 2025, distributed worldwide.

    Product
    B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1802-2026·2026-04-22

    B. Braun Hemodialysis Bloodlines Recalled Due to Air Bubble Accumulation Risk

    B. Braun has recalled hemodialysis bloodlines due to potential air bubble accumulation in the arterial line. The recall affects 4,848 units distributed nationwide and in Canada.

    Product
    B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1482-2026·2026-03-11

    B. Braun Infusion Needle Recall: Potential Dull or Broken Needle Tip

    B. Braun is recalling 21,000 units of its 21GA WINGED INFUSION needle due to the potential for needle tips to be dull, blunt, or break during use. The defect affects subcutaneous implant procedures.

    Product
    Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneou
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1481-2026·2026-03-11

    B. Braun Winged Infusion Needle Recalled for Dull or Broken Needle Tips

    B. Braun is recalling approximately 105,550 BBraun Medical 21G X4.4CM Winged Infusion Needles due to potential for needle tips to be dull, blunt, or prone to breaking.

    Product
    Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percut
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1483-2026·2026-03-11

    B. Braun Tissue Expander Injection Needles Recalled for Defective Needle Tips

    B. Braun has recalled 51,300 units of its 21GA Winged Infusion Set due to potential needle defects. The needle tips may be dull, blunt, difficult to advance, or prone to breaking during use.

    Product
    Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0687-2026·2025-12-03

    B Braun IV Administration Sets Recalled for Backflow and Occlusion Risk

    B Braun Medical is recalling IV administration sets due to potential backflow of medication from secondary containers into primary containers and inability to prime. The defect may result in wrong medication delivery or medication delivery failure.

    Product
    IV Administration Set 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. IV ADMIN SET W/CARESITE EXT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0696-2026·2025-12-03

    B Braun IV Administration Sets Recalled for Backflow and Occlusion Risk

    B Braun Medical is recalling 4,536 IV Administration Sets worldwide due to potential backflow of medication from secondary containers into primary containers and inability to prime. This could compromise safe medication delivery.

    Product
    IV Administration Set 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. IV ADMIN SET W/ 15 DROPS/ML
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0711-2026·2025-12-03

    IV Administration Set with SafeDAY Recalled Due to Backflow Risk

    B Braun Medical Inc is recalling approximately 200,917 IV administration sets with SafeDAY components due to potential medication backflow between IV containers and blockage that may prevent line preparation.

    Product
    SafeDAY set 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. IV ADMIN SET 60 DROP W/2 SAFEDAY; Cat
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0658-2026·2025-12-03

    IV Administration Set Recalled Due to Potential Medication Backflow and Occlusion

    B Braun Medical Inc recalls IV administration sets due to potential backflow of medication from secondary containers into primary containers and inability to prime.

    Product
    IV Administration Set 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. IV SET 15DR 3 CARESITE, 124
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0692-2026·2025-12-03

    IV Administration Sets recalled due to backflow and occlusion potential

    B. Braun Medical Inc is recalling 45,288 units of IV Administration Sets due to potential backflow of medication from secondary containers into primary containers and inability to prime, which could cause improper medication delivery or line contamination.

    Product
    IV Administration Set 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. 130 IN. IV ADMIN SET W/ 9 I
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0681-2026·2025-12-03

    IV Administration Sets recalled for potential medication backflow

    B Braun Medical Inc is recalling 63,192 IV Administration Sets due to potential backflow of medication from secondary IV containers into primary containers and inability to prime the sets.

    Product
    IV Administration Set 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. IV ADMIN SET W/10 DROPS, 13
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0623-2026·2025-12-03

    B Braun CARESAFE IV Administration Sets Recalled for Medication Backflow Risk

    B Braun Medical is recalling CARESAFE IV administration sets due to potential medication backflow from secondary to primary containers and inability to prime. Approximately 4,438 units are affected worldwide.

    Product
    CARESAFE 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. CARESAFE IV ADMIN SET w/AIRSTOP, 104 IN
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0680-2026·2025-12-03

    IV Administration Sets Recalled Due to Backflow and Occlusion Risks

    B Braun Medical Inc is recalling approximately 12,200 IV Administration Sets worldwide due to potential backflow of medication from secondary IV containers into primary containers and inability to prime. No illnesses have been reported.

    Product
    IV Administration Set 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. NF1503 15 DR UNIV SPIKE, IN
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0716-2026·2025-12-03

    IV Administration Sets Recalled for Potential Medication Backflow and Occlusion

    B Braun Medical Inc is recalling Outlook IV administration sets due to potential backflow of medication from secondary to primary IV containers and inability to prime. No illnesses reported.

    Product
    Outlook set 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. OUTLOOK IV SET 15DR W/2 CARESITE FILT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0634-2026·2025-12-03

    Extension Sets for IV Pumps Recalled Due to Medication Backflow Risk

    B Braun Medical is recalling extension sets used with infusion pumps due to potential backflow of medication between IV containers and inability to prime. No injuries have been reported.

    Product
    Extension Set 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. EXTENSION SET W/ ULTRAPORT, 48 IN.;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0668-2026·2025-12-03

    IV Administration Sets: Risk of Medication Backflow and Priming Failure

    B Braun Medical Inc recalls IV Administration Sets due to potential medication backflow from secondary into primary containers and priming failure. Worldwide distribution to US, Canada, Germany, Guatemala, and Singapore.

    Product
    IV Administration Set 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. IV ADMIN SET W/15 DROPS/ML,
    Category
    Medical Device
    Distribution
    0 states