Baxter Healthcare Corporation recall records

273 reported ongoing

306 records in this archive. Latest source date Aug 17, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

APD Drain Manifold

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

Class IIReported terminated

Distribution: US Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.

Official source for APD Drain Manifold
FDA device enforcement

Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field ...

There is a potential for foreign matter.

Class IIReported terminated

Distribution: Distribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS distribution to Japan, Italy, Netherlands, Switzerland, and United Kingdom

Official source for Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to s...
FDA device enforcement

PrisMax System, Product Code 955626

This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return Pressure Drop Limit (RDL) and uses the Same Patient function,...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Mexico, Brazil, Jamaica, Trinidad and Tobago, Canada, Australia, Singapore, Hong Kong, Vietnam, New Zealand, Korea, A...

Official source for PrisMax System, Product Code 955626
FDA device enforcement

PrisMax System, Product Code 955724

This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return Pressure Drop Limit (RDL) and uses the Same Patient function,...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Mexico, Brazil, Jamaica, Trinidad and Tobago, Canada, Australia, Singapore, Hong Kong, Vietnam, New Zealand, Korea, A...

Official source for PrisMax System, Product Code 955724
FDA device enforcement

PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701

This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return Pressure Drop Limit (RDL) and uses the Same Patient function,...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Mexico, Brazil, Jamaica, Trinidad and Tobago, Canada, Australia, Singapore, Hong Kong, Vietnam, New Zealand, Korea, A...

Official source for PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701
FDA device enforcement

Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.

Product is mislabeled as self-righting Luer slip tip caps, yellow.

Class IIReported terminated

Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, GA, IL, IN, MO, PA, TX, and VA. The countries of Canada, Austria, Germany, Netherlands, Qatar, Saudi Ara...

Official source for Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip ca...
FDA device enforcement

Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P3156087.

An incorrect center bolt was used in the assembly of the product which could result in a patient fall during use.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IN, KS, KY, LA, MA, MD, MI, MN, MO, ND, NE, NJ, NV, NY, OH, OK, OR, ...

Official source for Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, mode...
FDA device enforcement

Compella Bariatric Bed System

Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.

Class IIReported terminated

Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Cameroon, Canada, Estonia, Finland, France, Georgia, ...

Official source for Compella Bariatric Bed System
FDA device enforcement

Compella Therapy Air Supply Unit

Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.

Class IIReported terminated

Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Cameroon, Canada, Estonia, Finland, France, Georgia, ...

Official source for Compella Therapy Air Supply Unit
FDA device enforcement

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extend...

Class IIReported ongoing

Distribution: Worldwide

Official source for Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483
FDA device enforcement

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extend...

Class IIReported ongoing

Distribution: Worldwide

Official source for Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ
FDA device enforcement

Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de torsion, 5C4482S

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extend...

Class IIReported ongoing

Distribution: Worldwide

Official source for Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de torsion, 5C4482S
FDA device enforcement

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extend...

Class IIReported ongoing

Distribution: Worldwide

Official source for Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482
FDA device enforcement

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extend...

Class IIReported ongoing

Distribution: Worldwide

Official source for Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E

Reasons in these listed records

  • Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
  • Firm discovered a firmware memory leak with a supplier-manufactured component.
  • There is a potential for foreign matter.
  • This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return Pressure Drop Limit (RDL) and uses the Same Patient function, the PrisMax System ...

These examples come from this result page and are not a ranking of every recall reason.

Checking Baxter Healthcare Corporation

Is there a recall on baxter healthcare corporation right now?

This archive contains 306 records, including 273 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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