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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 221–240 of 7756 recalls

CLEARLINK NON-DEHP Solution Set (Baxter) – IV Set Leak (2025)

IV sets may leak.

FDAAug 29, 2025Nationwide• Baxter Healthcare Corporation

Getinge 88-Series Washer (Getinge) – Overheating Potential (2025)

Potential for device to overheat during operation f the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.

FDAAug 29, 2025Nationwide• Getinge Disinfection Ab Ljungadalsgatan

CLEARLINK System Solution Set (Baxter) – IV Set Leak (2025)

IV sets may leak.

FDAAug 29, 2025Nationwide• Baxter Healthcare Corporation

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Aripiprazole Tablets (Ascend) – Superpotent drug risk (2025)

Superpotent drug

Class IIModerate

FDAAug 28, 2025Nationwide• Ascend Laboratories, LLC

Extractor Pro Retrieval Catheter (Boston Scientific) – Incorrect Labeling (2025)

The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.

FDAAug 28, 2025Nationwide• Boston Scientific Corporation

Osstem Dental X-Ray System (Osstem) – Labeling Issue (2025)

Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.

FDAAug 26, 2025Nationwide• OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)

Cream Caramels (Abdallah) – undeclared nuts (2025)

Undeclared Allergen

Undeclared allergen (peanut, pecan).

Class IIModerate

FDAAug 25, 2025PA• Abdallah Incorporated

Sea Salt Caramel Dark Miniature (Abdallah) – undeclared nuts (2025)

Undeclared Allergen

Undeclared allergen (peanut, pecan).

Class IIModerate

FDAAug 25, 2025PA• Abdallah Incorporated

Venclose digiRF Generator (Bard) – Wiring Detection Feature (2025)

Laceration Risk

Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use. This automated diagnostic check is executed immediately upon catheter connection to the generator, occurring before the procedure interface becomes accessible. When a catheter fails this verification process, the generator displays a Red X indicator on the screen without accompanying error codes, effectively disabling catheter functionality. However, BD has determined that software version 3.35 generates false positive failures due to temperature-dependent verification parameters, incorrectly flagging properly functioning Venclose EVSRF Ablation Catheters as defective when the catheter temperature is not at steady state during the check initiation.

FDAAug 21, 2025Nationwide• Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438

PROPONENT DR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

Stay Informed

Baxter Healthcare Corporation Recalls

Recall Summary

CLEARLINK NON-DEHP Solution Set (Baxter) – IV Set Leak (2025)

Getinge 88-Series Washer (Getinge) – Overheating Potential (2025)

CLEARLINK System Solution Set (Baxter) – IV Set Leak (2025)

Aripiprazole Tablets (Ascend) – Superpotent drug risk (2025)

Extractor Pro Retrieval Catheter (Boston Scientific) – Incorrect Labeling (2025)

Osstem Dental X-Ray System (Osstem) – Labeling Issue (2025)

Cream Caramels (Abdallah) – undeclared nuts (2025)

Sea Salt Caramel Dark Miniature (Abdallah) – undeclared nuts (2025)

Venclose digiRF Generator (Bard) – Wiring Detection Feature (2025)

PROPONENT DR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

ACCOLADE DR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

ESSENTIO SR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

PROPONENT SR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

ALTRUA 2 DR EL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

PROPONENT DR VDD SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

PROPONENT DR EL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

ESSENTIO SR SL MRI Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

VALITUDE CRT-P EL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

PROPONENT DR EL MRI Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

VISIONIST CRT-P EL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)