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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 701–720 of 4465 recalls

Sodium Chloride Injection (B. Braun) – Sterility Leak Risk (2023)

Lack of assurance of sterility: bags have the potential to leak.

Class IIModerate

FDAJul 5, 2023Nationwide• B. Braun Medical Inc.

Wireless Foot Switch distributed with Philips Allura Xper... (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands) – loss of availability of the wireless ... (2023)

Loss of availability of the wireless foot switch during procedures.

FDAJun 30, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Multi Grain Bread (Rose Street) – Undeclared Sesame (2023)

Undeclared Allergen

Bread contains undeclared sesame.

1...34 353637 38...224

Page 36 of 224Next

Class I

High

FDAJun 26, 2023MN• Rose Street Bread Lab

UroLift Visual Obturator (Scholly Fiberoptic) – Weld Defect (2023)

There is an improperly performed weld between the cone of the sheath lock and tube of the obturator; mechanical load capacity is impaired, and fracture of the welded joint may occur. Contamination can occur in this capillary gap, which is not covered by the reprocessing validations performed.

FDAJun 23, 2023Nationwide• Scholly Fiberoptic Gmbh Robert-Bosch-Str. 1-3 Denzlingen Germany

BLUE BIRD ALL AMERICAN Transit Bus (Blue Bird) – Instrument Cluster Error (2023)

Blue Bird Body Company (Blue Bird) is recalling certain 2022-2024 All American transit buses. A software error in the instrument cluster may cause the air pressure gauges and the visual and audio low air warnings to not function. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 121, "Air Brake Systems."

NHTSAJun 13, 2023Nationwide• BLUE BIRD

BLUE BIRD ALL AMERICAN School Bus (Blue Bird) – Instrument Cluster Error (2023)

Blue Bird Body Company (Blue Bird) is recalling certain 2021-2024 All American and 2021-2022 Vision school buses. A software error in the instrument cluster may cause the air pressure gauges and the visual and audio low air warnings to not function. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 121, "Air Brake Systems."

NHTSAJun 13, 2023Nationwide• BLUE BIRD

Allura Xper X-ray System (Philips) – FlexMove Carriage Defect (2023)

The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.

FDAJun 12, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Azurion 7 X-ray System (Philips) – FlexMove Carriage Defect (2023)

The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.

FDAJun 12, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Amplatzer Steerable Delivery Sheath (Abbott) – Air Embolism Risk (2023)

There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.

FDAJun 12, 2023Nationwide• Abbott

BeamAdjust Software (PTW-FREIBURG) – Calibration File Error (2023)

Generated calibration file will not be correct in case of a relative calibration of an OCTAVIUS Detector 1000 or OCTAVIUS Detector 1600, if a Tiff file or a DICOM data set is used as reference matrix. Therefore, the measurement result will be incorrect by using such a calibration file.

FDAJun 7, 2023Nationwide• PTW-FREIBURG Lorracher Str. 7 Freiburg Im Breisgau Germany

Perifix Epidural Kit (B. Braun) – Incorrect Filter Straw (2023)

Kits were assembled with the incorrect Filter Straw.

FDAJun 5, 2023Nationwide• B. Braun Medical, Inc.

Design Options Epidural Kit (B. Braun) – Incorrect Filter Straw (2023)

Kits were assembled with the incorrect Filter Straw.

FDAJun 5, 2023Nationwide• B. Braun Medical, Inc.

DxA Automation System (Beckman Coulter) – Test Sample Compatibility (2023)

A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results

FDAJun 2, 2023AL, CA, FL +16 more• Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany

UFSK Treatment Chair 500 XLE (UFSK) – Drive Mechanism Wear (2023)

Service life of the electrical seat part drive of the treatment chair may be shortened unexpectedly after several years of use due to a potential wear-related reduction in the self-locking of the drive and may remain undetected. A worsened self-locking of the seat drive can lead to overriding the drive s end position when positioning the patient with the seat part in an inclined position

FDAMay 31, 2023Nationwide• UFSK International OSYS Gmbh Kirchhoffstr. 1 Ratisbon Germany

Ziprasidone Hydrochloride Capsules (Harvard Drug Group) – Label Mix-up (2023)

Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.

Class IHigh

FDAMay 31, 2023Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Alinity ci-series Control Module (Abbott) – System Performance Issues (2023)

There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new lots of value assigned Calibrators; 4) Error in processing tests after CCCintController encountered an error with the assay information downloaded from SCC; 5) The assay editor does not correctly check sample dilution total volume limits; 6) User-Applied Labels not adhering to Reagent Bottles; 7) ICT Module did not expire after warranty was exceeded. These performance issues could lead to erroneous results for multiple analytes.

FDAMay 30, 2023AL, AK, AZ +43 more• Abbott Laboratories

RET Proximal Probe. Used in Fluorescence in situ hybridiz... (Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom) – dnas used during the manufacture of t... (2023)

DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.

FDAMay 24, 2023Nationwide• Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom

RET Distal Probe. Used in Fluorescence in situ hybridizat... (Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom) – dnas used during the manufacture of t... (2023)

DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.

FDAMay 24, 2023Nationwide• Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom

SAF-T-LINER C2 Jouley (Thomas Built Buses) – Structural Issue (2023)

Daimler Trucks North America, LLC (DTNA) is recalling certain 2021-2024 Thomas Built SAF-T-LINER C2 and 2021-2023 Thomas Built SAF-T-LINER C2 Jouley school buses. A rear interior joint may have been manufactured incorrectly, resulting in insufficient joint strength. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 221, "School Bus Body Joint Strength."

NHTSAMay 9, 2023Nationwide• THOMAS BUILT BUSES

Express Plus Type I (Braun Ambulances) – Service Brake Problem (2023)

Braun Ambulances (Braun) is recalling certain 2019-2023 Chief XL Type I, Express Plus Type I, and Liberty Type I ambulances built on Chevrolet medium and heavy-duty chassis. The Liquid Spring suspension systems may come in direct contact with the right rear brake line, causing excessive wear and possibly resulting in the loss of the rear brakes.

NHTSAMay 9, 2023Nationwide• BRAUN AMBULANCES