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B. Braun Medical, Inc.

B. Braun Medical, Inc. Recalls

All product recalls associated with B. Braun Medical, Inc..

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Recall Summary

Total Recalls

1000

Past Year

295

Class I (Serious)

116

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 3781–3800 of 4465 recalls

B. Braun Medical, Inc.: Ultrasite IV Administration Set with Universal Spike, thr...

Device defect is occlusion/no flow.

FDAMar 27, 2009Nationwide• B. Braun Medical, Inc.

B. Braun Medical, Inc.: Outlook Safety Infusion System IV Set with Universal Spik...

Device defect is occlusion/no flow.

FDAMar 27, 2009Nationwide• B. Braun Medical, Inc.

B. Braun Medical, Inc.: Ultrasite ADDitIV Primary IV Set with Universal Spike, Ba...

Device defect is occlusion/no flow.

FDAMar 27, 2009Nationwide• B. Braun Medical, Inc.

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Abbott Vascular-Cardiac Therapies dba Guidant Corporation: Xact 10 mm x 20 mm x 136 cm (Part Number 82099-01) The X...

Abbott Vascular is initiating a recall on the XACT Carotid Stent System because the product was distributed prior to approval of a PMA supplement for a manufacturing line move between sites. There are no product quality issues associated with this action.

FDAMar 19, 2009Nationwide• Abbott Vascular-Cardiac Therapies dba Guidant Corporation

Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany: BrainLab m3 Micro-Multileaf-Collimator for Varian Type II...

The Integrated Multileaf-Collimator (MLC) of the linear accelerator could interfere with the intended conformal fields of the BrainLab m3 micro-Multileaf-Collimator (mMLC) during patient treatment.

FDAMar 19, 2009Nationwide• Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany

Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany: BrainLab Micro-Multileaf-Collimator, model 41600; BrainLa...

The Integrated Multileaf-Collimator (MLC) of the linear accelerator could interfere with the intended conformal fields of the BrainLab m3 micro-Multileaf-Collimator (mMLC) during patient treatment.

FDAMar 19, 2009Nationwide• Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany

Abbott Vascular-Cardiac Therapies dba Guidant Corporation: Xact 9 mm x 20 mm x 136 cm (Part Number 82089-01) The Xa...

FDAMar 19, 2009Nationwide• Abbott Vascular-Cardiac Therapies dba Guidant Corporation

Abbott Diabetes Care, Inc.: FreeStyle Blood Glucose Monitoring System Test Strips and...

Product dispositioned for destruction was potentially diverted to end users.

FDAMar 13, 2009Nationwide• Abbott Diabetes Care, Inc.

BioTek Instruments, Inc. Highland Park/Box: BioTek Gen5CL Microplate Data Collection and Analysis So...

Software design allowed false negatives to be read when wells are dark.

FDAMar 12, 2009Nationwide• BioTek Instruments, Inc. Highland Park/Box

Wall-Mounted Radiators (Rettig) – Crush Hazard (2009)

The recalled radiators are used to heat a home and are mounted vertically to the wall. The recall involves the Radson Vertical 20 and 21, Radson Kos V21, and Radson Faro V21.

CPSCMar 5, 2009Nationwide• Rettig Belgium NV, of Belgium

Abbott Laboratories: ARCHITECT Reaction Vessel, 2000 units per carton; for in ...

Abbott has had an increase in complaints due to the receipt of error code 1006 (unable to process test, background read failure), error code 1007 (unable to process test, activated read failure) and incorrect results when using these lots of ARCHITECT Reaction Vessels.

FDAFeb 26, 2009Nationwide• Abbott Laboratories

Abbott Point of Care Inc.: i-STAT EG7+ Cartridge; pH, PCO, PO, Na , K, iCa, Hct. Tes...

Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals.

FDAFeb 23, 2009Nationwide• Abbott Point of Care Inc.

Abbott Point of Care Inc.: i-STAT G3+ Cartridge; pH, PCO, PO. HCO2, TCO2, BE sO2; Te...

Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals.

FDAFeb 23, 2009Nationwide• Abbott Point of Care Inc.

Abbott Laboratories: Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro ...

The AxSYM Cancer Assay Disk (LN 3D50-05 version 5.0) contains an AxSYM AFP assay file where the Low Concentration flag for the AFP 1:101 automated dilution protocol the instrument to report results between 0 ng/mL and 0.4 ng/mL (40.4 ng/mL accounting for the 1:101 dilution). The sensitivity of the assay is 0.4 ng/mL.

FDAFeb 20, 2009Nationwide• Abbott Laboratories

Abbott Laboratories: AxSYM System Tubing Decontamination Solution; 500 mL bott...

Bottle labels from lot 211974, AxSYM System Tubing Decontamination Solution (List Number 7B05-09), were found to be missing the following information: lot number, date of manufacture, and expiration date.

FDAFeb 18, 2009Nationwide• Abbott Laboratories

Abbott Laboratories: Cell-Dyn Ruby Hematology Analyzer with System Software Ve...

Fire/Burn Risk

Burn Risk-- when power is cycled to the instrument, there is a possibility that the Mixer Motor Assembly may reach 100 degrees Celsius (212 degrees Fahrenheit ). If the customer touches the motor, burns may occur.

FDAFeb 12, 2009PR• Abbott Laboratories

BD Biosciences, Systems & Reagents: BD FACSCount Controls Kit, An Automated Differential Cell...

The product is mislabeled, in that, zero/low controls were mislabeled as medium/high, and the medium/high controls were labeled zero/low.

FDAJan 29, 2009Nationwide• BD Biosciences, Systems & Reagents

Biogenex Laboratories: Xmatrx FISH (fluorescent in situ hybridization) Automated...

Under certain conditions, product system failure has the potential to cause operator injury due to splash of Hemo-De solution.

FDAJan 23, 2009Nationwide• Biogenex Laboratories

Bio-Rad Laboratories Inc: VARIANT II TURBO Hemoglobin Testing System with CDM 3.6T ...

Sample test results for the first run appears to be correct but all subsequent results during that run were assigned incorrect barcode and tube position.

FDAJan 22, 2009Nationwide• Bio-Rad Laboratories Inc

Bio-Rad Laboratories Inc: VARIANT II Hemoglobin Testing System with CDM 3.5 Softwar...

Sample test results for the first run appears to be correct but all subsequent results during that run were assigned incorrect barcode and tube position.

FDAJan 22, 2009Nationwide• Bio-Rad Laboratories Inc