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Baxter Healthcare Corporation

Baxter Healthcare Corporation Recalls

All product recalls associated with Baxter Healthcare Corporation.

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Recall Summary

Total Recalls

1000

Past Year

567

Class I (Serious)

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 581–600 of 7756 recalls

Baxter Solution Set (Baxter) – Inverted Side Clamps (2024)

Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.

FDADec 20, 2024Nationwide• Baxter Healthcare Corporation

Life2000 Ventilation System (Baxter) – Battery Charger Alarm (2024)

There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.

FDADec 20, 2024Nationwide• Baxter Healthcare Corporation

AXIOS Stent Delivery System (Boston Scientific) – Outer Sheath Detachment (2024)

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

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Page 30 of 388Next

FDA

Dec 20, 2024

Nationwide

• Boston Scientific Corporation

AXIOS Stent Delivery System (Boston Scientific) – Stent Saddle Problem (2024)

FDADec 20, 2024Nationwide• Boston Scientific Corporation

Lipoprotein (a) Test (Randox) – 510(k) Compliance Issue (2024)

Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.

FDADec 20, 2024Nationwide• Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom

Clearlink System Solution Set (Baxter) – Inverted Side Clamps (2024)

Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.

FDADec 20, 2024Nationwide• Baxter Healthcare Corporation

Continu-Flo Solution Set (Baxter) – Inverted Side Clamps (2024)

Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.

FDADec 20, 2024Nationwide• Baxter Healthcare Corporation

HOT AXIOS Stent Delivery System (Boston Scientific) – Outer Sheath Issue (2024)

FDADec 20, 2024Nationwide• Boston Scientific Corporation

CryoSolutions Cartridges (New Medical Technologies) – Valve Premature Opening (2024)

During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.

FDADec 19, 2024Nationwide• New Medical Technologies Gmbh Wankdorffeldstrasse

Bodor P and C Series Laser Machines (Jinan Bodor) – Non-Compliant Lasers (2024)

Non-compliant laser products

FDADec 19, 2024Nationwide• Jinan Bodor Cnc Machine Co Ltd NO.1299, XINLUO AVE HI-TECH ZONE Jinan China

Stryker Blueprint Mixed Reality Pin Guide (Tornier) – Device Disassembly Risk (2024)

The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide and potentially prolonging surgery time or changing of surgical method from guided to conventional.

FDADec 18, 2024AK, ID, KY +4 more• Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France

Monitoring Service Application (Braemar) – ECG Event Processing (2024)

Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring service application software.

FDADec 18, 2024Nationwide• Braemar Manufacturing, LLC

Wicklow Gold Cheddar Tomato & Herb (Abbey) - Listeria Risk (2024)

Listeria

Product may have Listeria Monocytogenes.

Class IHigh

FDADec 18, 2024CO, MA, OH• Abbey Specialty Foods

HemosIL Heparin Calibrators (Instrumentation Laboratory) – Quality Control Problem (2024)

Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.

FDADec 18, 2024Nationwide• Instrumentation Laboratory

Wicklow Gold Cheddar Nettle & Chive (Abbey) - Listeria Risk (2024)

Listeria

Product may have Listeria Monocytogenes.

Class IHigh

FDADec 18, 2024CO, MA, OH• Abbey Specialty Foods

VALITUDE CRT-P (Boston Scientific) – Safety Mode Potential (2024)

A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.

FDADec 12, 2024Nationwide• Boston Scientific Corporation

Stay Informed

Baxter Healthcare Corporation Recalls

Recall Summary

Baxter Solution Set (Baxter) – Inverted Side Clamps (2024)

Life2000 Ventilation System (Baxter) – Battery Charger Alarm (2024)

AXIOS Stent Delivery System (Boston Scientific) – Outer Sheath Detachment (2024)

AXIOS Stent Delivery System (Boston Scientific) – Stent Saddle Problem (2024)

Lipoprotein (a) Test (Randox) – 510(k) Compliance Issue (2024)

Clearlink System Solution Set (Baxter) – Inverted Side Clamps (2024)

Continu-Flo Solution Set (Baxter) – Inverted Side Clamps (2024)

HOT AXIOS Stent Delivery System (Boston Scientific) – Outer Sheath Issue (2024)

CryoSolutions Cartridges (New Medical Technologies) – Valve Premature Opening (2024)

Bodor P and C Series Laser Machines (Jinan Bodor) – Non-Compliant Lasers (2024)

Stryker Blueprint Mixed Reality Pin Guide (Tornier) – Device Disassembly Risk (2024)

Monitoring Service Application (Braemar) – ECG Event Processing (2024)

Wicklow Gold Cheddar Tomato & Herb (Abbey) - Listeria Risk (2024)

HemosIL Heparin Calibrators (Instrumentation Laboratory) – Quality Control Problem (2024)

Wicklow Gold Cheddar Nettle & Chive (Abbey) - Listeria Risk (2024)

VALITUDE CRT-P (Boston Scientific) – Safety Mode Potential (2024)

PROPONENT DR Pacemaker (Boston Scientific) – Safety Mode Potential (2024)

ESSENTIO DR Pacemaker (Boston Scientific) – Safety Mode Potential (2024)

VISIONIST CRT-P (Boston Scientific) – Safety Mode Potential (2024)

ALTRUA 2 DR Pacemaker (Boston Scientific) – Safety Mode Potential (2024)