B. Braun
128 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for B. Braun and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-09-09FDA-DeviceClass IIB Braun Discofix Stopcock Set recalled for mislabeled expiration date
Specific lots of B Braun's Discofix Four Way Stopcock extension sets have an incorrect expiration date printed on the carton shipper label. This labeling error could affect proper product tracking and usage verification.
- 2026-08-27FDA-PRB. Braun saline injection recalled for particulate contamination
B. Braun Medical Inc. is recalling three lots of 0.9% Sodium Chloride Injection (saline solution) used in hospitals and healthcare settings. The recalled product contains particles of zinc oxide that should not be present. Intravenous fluids contaminated with particulate matter can cause serious complications including blood clots and organ damage. No injuries have been reported so far.
- 2026-04-28FDA-PRStop using B. Braun Lactated Ringer's Injection
B. Braun Medical is recalling two lots of Lactated Ringer's Injection (1L, product code E7500) because the solution contains unwanted particles, including cellulose and stearates. If these particles enter a patient's bloodstream during use, they could cause serious complications including blood clots, tissue damage, or organ failure.
- 2026-04-22FDA-DeviceClass IStop using B Braun hemodialysis bloodlines Model B3-4630M4705
B Braun Medical Inc is recalling specific hemodialysis bloodline tubing (Model B3-4630M4705) because small air bubbles can accumulate in the arterial line when blood gases stick to the tubing under negative pressure. This could affect dialysis treatment safety. The recall affects units manufactured since August 5, 2025.
- 2026-04-22FDA-DeviceClass IStop using B. Braun hemodialysis bloodlines model B3-3632M3705
B. Braun Medical Inc is recalling specific hemodialysis bloodline tubing because small air bubbles can accumulate in the arterial line during dialysis treatment. This happens when blood gases stick to the tubing when negative pressure is applied. The affected units were manufactured on or after August 1, 2025.
- 2026-04-22FDA-DeviceClass IStop using B. Braun StreamLine Bloodline tubing
B. Braun Medical Inc is recalling certain hemodialysis bloodlines (model SL-2000M2095L) because small air bubbles can collect in the arterial line when the tubing is under negative pressure. This happens because blood gases stick to the inside of the tubing. No injuries have been reported.
- 2026-04-22FDA-DeviceClass IB. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
- 2026-04-22FDA-DeviceClass IB. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
- 2026-04-22FDA-DeviceClass IStop using B. Braun STREAMLINE BLOODLINE SET
B. Braun Medical Inc is recalling STREAMLINE BLOODLINE SET FOR DIALOG DR. (Model SL-2010M2096A) due to a potential risk of small air bubbles accumulating in the arterial line during hemodialysis treatment. This happens when blood gases stick to the tubing under negative pressure, which could affect treatment safety. The recall affects units manufactured on or after June 9, 2025.
- 2026-03-11FDA-DeviceClass IIStop using B. Braun infusion sets (Model 7M2802)
B. Braun Medical Inc. recalled certain winged infusion sets used to expand tissue expanders because the needle tips may be dull, blunt, or break during use. This could make it difficult to insert the needle or cause it to break inside the body. No injuries have been reported.
- 2026-03-11FDA-DeviceClass IIStop using B. Braun infusion needles (Model 7A3842)
B. Braun Medical Inc is recalling certain 21-gauge winged infusion needles used to expand tissue expanders. The needle tips may be dull, blunt, or break during use, which could make the device difficult or impossible to use properly.
- 2026-03-11FDA-DeviceClass IIStop using B. Braun 21G injection needles
B. Braun's 21G winged injection needles used for tissue expander procedures may have dull, blunt, or broken needle tips. This can make the needle difficult to advance during use. The issue affects specific lot numbers with expiration dates through September 2032.
- 2025-12-03FDA-DeviceClass IIIV 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, 110 IN.; Catalog Number: 490566.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-12-03FDA-DeviceClass IIIV 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/ 15DROPS/ML; Catalog Number: 490508.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-12-03FDA-DeviceClass IIOutlook 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 FILTER; Catalog Number: 354214.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-12-03FDA-DeviceClass IIVista 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. VISTA BASIC PUMP IV SET W/ 15 DROP/ML; Catalog Number: US9923F.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-12-03FDA-DeviceClass IIULTRASITE 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/ 2 ULTRASITE VLV, 104 IN; Catalog Number: 352049-C. 2. IV ADMIN SET W/ 3 ULTRASITE VLV, 112 IN; Catalog Number: 375100-C.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-12-03FDA-DeviceClass IISAFELINE 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. UNIVERSAL IV ADMIN SET; Catalog Number: 352604. 2. SAFELINE ADDITIV ALTVTD 3 INJ S; Primary Gravity IV Set with 3 SafeLine Injection Sites; Catalog Number: NF1251. 3. SAFELINE PED. ADDITIVE; Primary Gravity IV Set with 3 SafeLine Injection Sites; C
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-12-03FDA-DeviceClass IISafeDAY 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 ADM SET 15 DR W/2 SAFEDAY & STOPCOCK; Catalog Number: 352646.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-12-03FDA-DeviceClass IISafeDAY 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; Catalog Number: 352635.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-12-03FDA-DeviceClass IIRATE FLOW 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. RATEFLOW ADMIN 15 DROP W/2 CARESITES; Catalog Number: 375258.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-12-03FDA-DeviceClass IIOutlook 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 15DROP W/2 CARESITE; Catalog Number: 354212.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-12-03FDA-DeviceClass IIOutlook 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 PUMP SET 3 CARESITE LADS 133 IN.; Catalog Number: 490564.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-12-03FDA-DeviceClass IIOutlook 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 15DROP W/3 CARESITE; Catalog Number: 354213.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-12-03FDA-DeviceClass IIOutlook 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 PUMP SET,3 CARESITE LADS,115 IN.; Catalog Number: 490361.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-12-03FDA-DeviceClass IIIV 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. AESTHESIA IV SET, 127 in.; Catalog Number: 490551.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-12-03FDA-DeviceClass IIIV 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, 129 IN, 3 CARESITE LADS; Catalog Number: 490225.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-12-03FDA-DeviceClass IIIV 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 AD.SET W/15 DR 128 IN, EXT SET 9 IN; Catalog Number: 490301.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-12-03FDA-DeviceClass IIIV 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, 15DR, CARESITE LAD, 130 IN; Catalog Number: 477002. 2. IV ADMIN SET 85 IN.; Catalog Number: 477017.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-12-03FDA-DeviceClass IIIV 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. NF1500UP, IV ADMINISTRATION SET; Catalog Number: 490070.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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