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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 1881–1900 of 7756 recalls

Baxter Healthcare Corporation: Prismaflex HF20 Set (product code 109841). For use in pr...

Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.

FDASep 14, 2022Nationwide• Baxter Healthcare Corporation

Phytonadione Injectable Emulsion (Dr. Reddy's) – Aluminum Content (2022)

Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.

Class IIILow

FDASep 14, 2022Nationwide• Dr. Reddy's Laboratories, Inc.

Skincell Mole Corrector Serum (Justified Labs) – Unapproved Drug (2022)

Marketed Without An Approved NDA/ANDA; Unapproved new drug

1...93 949596 97...388

Page 95 of 388Next

Class II

Moderate

FDASep 9, 2022Nationwide• Justified Laboratories

Skincell Mole Corrector Serum (Justified Labs) – Unapproved Drug (2022)

Marketed Without An Approved NDA/ANDA; Unapproved new drug

Class IIModerate

FDASep 9, 2022Nationwide• Justified Laboratories

BALT USA, LLC: Optima Coil System Model Number OPTI0208CSS10, Model...

Product pouch label does not match up with carton label

FDASep 7, 2022Nationwide• BALT USA, LLC

Baxter Healthcare Corporation: Starling Monitor, Product code CMMST5 and Starling Monito...

Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.

FDASep 2, 2022Nationwide• Baxter Healthcare Corporation

LUMINOSTICS, INC dba CLIP HEALTH: Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Numb...

COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence.

FDASep 2, 2022Nationwide• LUMINOSTICS, INC dba CLIP HEALTH

OMM Imports, Inc. dba Zero Gravity: Recreo Hair Growth Laser Comb

The firm distributed the laser products without affixing the warning, aperture, certification, and identification labels. In addition, the firm failed to provide safety information, reproductions and locations of the labels, and a warning statement in the user manual.

FDASep 1, 2022Nationwide• OMM Imports, Inc. dba Zero Gravity

Micro-X Ltd. A14 6 MAB Eastern Promenade Tonsley Australia: MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19

Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure management decisions

FDAAug 31, 2022Nationwide• Micro-X Ltd. A14 6 MAB Eastern Promenade Tonsley Australia

Organic Animal Crackers (Toufayan) – Undeclared Coconut (2022)

Undeclared Nuts

Undeclared tree nut: Coconut

Class IIModerate

FDAAug 26, 2022Nationwide• Toufayan Bakery of Plant City

A&W Root Beer Zero Sugar (BDCI) – Undeclared Sugar (2022)

Undeclared Allergen

Product contains undeclared sugar. Full sugar root beer was packaged in bottles labeled "sugar free"

Class IIModerate

FDAAug 26, 2022IN, MD, PA +3 more• Beverage Distribution Center Incorporated, LLC. (BDCI)

Stand-up Paddleboard Paddles (Agit Global) – Puncture Risk (2022)

Laceration Risk

This recall involves Agit Global paddles, model years 2015 through 2020, that were sold with the 8', 8'6", 9'6", and 10'6" Wave Storm, Storm Blade, Ozoboard, True Wave, Bloo Tide, Dorsal, and Rock It Surf Stand-up paddleboards. The paddles are made of aluminum and are adjustable, between 5 and 7 feet in length. The paddles were provided with original purchase or as a replacement paddle under warranty and were not sold individually. Each paddle is printed with a four- or five-character manufacturing code on the paddle blade with one of the following prefixes or codes: Model Year Initial Characters of Manufacturing Code 2015 9'6 Wave Storm J4 2015 10'6" Wave Storm D5 2015 9'6" Dorsal B4, J4 2015 8'6", 9'6", 10'6" Ozoboards H4, F5 2015, 2016, and 2017 9'6" and 10'6" Storm Blades E5, F5, L5, B6, C6, B7, D7, E7, F7, G7 2016 9'6" Wave Storm I5, A6 2017 9'6" Wave Storm I6, L6, A7 2018 9'6" Wave Storm I7, K7 2018 9'6" Rock-It-Surf L8 2018 8' True Wave E8 2019 9'6" Wave Storm I8, K8, J901, J902, J903, J904 2019 8' Wave Storm L8 2019 9'6" Bloo Tide C9 2020 8' Wave Storm D0

CPSCAug 25, 2022Nationwide• Agit Global Inc., of Taiwan

BATTERYJACK RS HELMET Equipment Recall: EQUIPMENT:MOTORCYCLE:HELMETS

BatteryJack Inc. (BatteryJack) is recalling certain RS helmets, model TN-0700, sizes SM, MED, LRG, and XL. The helmets may not adequately protect the wearer in the event of a head impact during a crash. As such, these helmets fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 218, "Motorcycle Helmets."

NHTSAAug 17, 2022Nationwide• BATTERYJACK

Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.: PTS Panels CHOL+GLU Test Strips (REF 1765)

Incorrect instructions for use were packaged into the final product.

FDAAug 16, 2022Nationwide• Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.

GFB Gluten Free Bites (Gluten Free Bar) – undeclared cashews (2022)

Undeclared Allergen

Undeclared cashews

Class IHigh

FDAAug 16, 2022AL, AR, CA +22 more• West Thomas Partners, LLC. dba Gluten Free Bar

Chamberlain Technologies LLC: SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, ...

Potential presence of residual adhesive material on the mesh surface.

FDAAug 12, 2022CA, IL, NE• Chamberlain Technologies LLC

Chamberlain Technologies LLC: SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sh...

Potential presence of residual adhesive material on the mesh surface.

FDAAug 12, 2022CA, IL, NE• Chamberlain Technologies LLC

Chicken Ranch Dressing (Max's Bakery) – listeria risk (2022)

Listeria

Proposition Chicken Ranch Dressing contains IQF Dill which is an ingredient recalled due to the presence of Listeria Monocytogenes.

Class IHigh

FDAAug 11, 2022Nationwide• Max's Bakery and Kitchen

Baxter Healthcare Corporation: Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-V...

Firm noted an increase in customer reports of leaks.

FDAAug 9, 2022Nationwide• Baxter Healthcare Corporation

Boston Scientific Corporation: Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Cath...

The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.

FDAAug 9, 2022IN• Boston Scientific Corporation