Baxter Healthcare recalls
34 recent recalls on record for Baxter Healthcare in connected official government data as of October 22, 2026 at 12:00 PM UTC.
Models with recalls
All Baxter Healthcare recalls
FDA Class II · Medical device · September 30, 2026
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product spec…
Official ID Z-3264-2026 ·
Official record ↗
FDA Class II · Medical device · September 30, 2026
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product spec…
Official ID Z-3263-2026 ·
Official record ↗
FDA Class II · Medical device · September 30, 2026
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product spec…
Official ID Z-3262-2026 ·
Official record ↗
FDA Class II · Medical device · September 30, 2026
Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devic…
Official ID Z-3257-2026 ·
Official record ↗
FDA Class I · Drug · September 16, 2026
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Official ID D-0850-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
Official ID Z-3066-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
Official ID Z-3065-2026 ·
Official record ↗
FDA Class I · Drug · September 9, 2026
Presence of particulate matter: Particulates identified as fiberglass
Official ID D-0849-2026 ·
Official record ↗
FDA Class II · Drug · September 9, 2026
CGMP Deviations
Official ID D-0821-2026 ·
Official record ↗
FDA Class II · Drug · September 9, 2026
CGMP Deviations
Official ID D-0820-2026 ·
Official record ↗
FDA Class II · Drug · September 9, 2026
CGMP Deviations
Official ID D-0819-2026 ·
Official record ↗
FDA Class II · Drug · September 9, 2026
CGMP Deviations
Official ID D-0818-2026 ·
Official record ↗
FDA Class II · Drug · September 9, 2026
CGMP Deviations
Official ID D-0817-2026 ·
Official record ↗
FDA Class II · Drug · September 9, 2026
CGMP Deviations
Official ID D-0816-2026 ·
Official record ↗
FDA Class II · Drug · September 9, 2026
CGMP Deviations
Official ID D-0815-2026 ·
Official record ↗
FDA Class II · Drug · September 9, 2026
CGMP Deviations
Official ID D-0814-2026 ·
Official record ↗
FDA Class II · Drug · September 9, 2026
CGMP Deviations
Official ID D-0813-2026 ·
Official record ↗
FDA Class II · Drug · September 9, 2026
CGMP Deviations
Official ID D-0812-2026 ·
Official record ↗
FDA Class II · Drug · September 9, 2026
CGMP Deviations
Official ID D-0811-2026 ·
Official record ↗
FDA Class II · Drug · September 9, 2026
CGMP Deviations
Official ID D-0810-2026 ·
Official record ↗
FDA Class II · Drug · September 9, 2026
CGMP Deviations
Official ID D-0809-2026 ·
Official record ↗
FDA Class II · Drug · September 9, 2026
CGMP Deviations
Official ID D-0808-2026 ·
Official record ↗
FDA Class II · Drug · September 9, 2026
CGMP Deviations
Official ID D-0807-2026 ·
Official record ↗
FDA Class II · Drug · September 9, 2026
CGMP Deviations
Official ID D-0806-2026 ·
Official record ↗
FDA Class II · Drug · September 9, 2026
CGMP Deviations
Official ID D-0805-2026 ·
Official record ↗
FDA Not Yet Classified · Drug · August 19, 2026
Presence of Particulate Matter
Official ID EVT-99463-1krekt6 ·
Official record ↗
FDA Class I · Medical device · August 19, 2026
Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.
Official ID Z-2766-2026 ·
Official record ↗
FDA Class I · Drug · August 19, 2026
Presence of Particulate Matter
Official ID D-0787-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Secti…
Official ID Z-2638-2026 ·
Official record ↗
FDA Class I · Medical device · July 8, 2026
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the p…
Official ID Z-2551-2026 ·
Official record ↗
FDA Class I · Medical device · July 8, 2026
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the p…
Official ID Z-2550-2026 ·
Official record ↗
FDA Class I · Medical device · July 8, 2026
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the p…
Official ID Z-2549-2026 ·
Official record ↗
FDA Class I · Medical device · July 8, 2026
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the p…
Official ID Z-2548-2026 ·
Official record ↗
FDA Class II · Medical device · June 10, 2026
Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slow…
Official ID Z-2262-2026 ·
Official record ↗
Compiled from official public-domain government data. Last checked October 22, 2026 at 12:00 PM UTC.