Recall archive
46 recalls · page 1 of 2
Reported Sep 2, 2026Updated Sep 7, 2026
Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA…
High riskUsing this product could cause serious injury, illness or death — stop using it now.B Braun Medical Inc.
Matched: Brand · Product · Product details — Presence of Particulate matter.
FDA (openFDA drug enforcement)
Reported May 13, 2026
Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC…
High riskUsing this product could cause serious injury, illness or death — stop using it now.B Braun Medical Inc.
Matched: Brand · Product · Product details — Presence of Particulate Matter.
FDA (openFDA drug enforcement)
Reported Sep 10, 2025
Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC…
High riskUsing this product could cause serious injury, illness or death — stop using it now.B Braun Medical Inc.
Matched: Brand · Product · Product details — Presence of Particulate Matter
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Aug 19, 2025
B. Braun Medical, Inc. recalls B. Braun Lactated Ringer’s Injection USP 1000 mL/0.9% Sodium Chloride Injection USP 1000 mL due to Due to the presence of…
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.B. Braun Medical, Inc.
Matched: Brand · Product · Product details — Due to the presence of particulate matter.
FDA (recalls & safety alerts)
Reported Apr 16, 2025
0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical Inc.
Matched: Brand · Product details — Presence of Particulate Matter
FDA (openFDA drug enforcement)
Reported Feb 5, 2025
Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter…
FDA (openFDA device enforcement)
Reported Sep 25, 2024
AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly…
FDA (openFDA device enforcement)
Reported Jul 24, 2024
OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV…
28 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2024
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 13, 2023
Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15…
High riskUsing this product could cause serious injury, illness or death — stop using it now.B. Braun Medical, Inc.
Matched: Brand — In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line…
FDA (openFDA device enforcement)
Reported Nov 15, 2023
FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand · Reason for recall — Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and…
8 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 1, 2023
8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
High riskUsing this product could cause serious injury, illness or death — stop using it now.B. Braun Medical, Inc.
Matched: Brand · Reason for recall — Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 4, 2023
B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand · Product · Product details — The sterile blister packaging may be damaged, and sterility may be compromised
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 27, 2023
Perifix¿ / Epidural anesthesia set, medicated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — Product may be mislabeled with an incorrect lid stock label.
FDA (openFDA device enforcement)
Reported Jul 5, 2023
Perifix¿ / Epidural anesthesia kit (10 count carton)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — Kits were assembled with the incorrect Filter Straw.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 14, 2022
0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand · Product · Product details — Lack of sterility assurance: Bags have the potential to leak.
FDA (openFDA drug enforcement)
Reported Oct 26, 2022
ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — The extension set has a high probability of failure which could lead to possible leakage or detachment at the device's bonded joint during use. The…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 23, 2022
0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand · Product · Product details — Lack of sterility assurance: leaking bags
FDA (openFDA drug enforcement)
Reported Mar 16, 2022
Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of…
FDA (openFDA device enforcement)
Reported Oct 6, 2021
15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or…
16 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 4, 2021
Infusomat Space Volumetric Pump Administration Set, Product Code 490100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to…
FDA (openFDA device enforcement)
Reported May 5, 2021
Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.
FDA (openFDA device enforcement)
Reported Feb 12, 2020
Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — Potential for leakage at the joint between the blood filters and tubing
6 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2019
B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
High riskUsing this product could cause serious injury, illness or death — stop using it now.B. Braun Medical, Inc.
Matched: Brand · Product · Product details — Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).
FDA (openFDA device enforcement)
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