SteriCare Sterile Water & Saline Solution Recall: Lawsuits and Settlement Claims

The FDA has issued a Class I recall—the agency’s most serious classification—for SteriCare Sterile Water and Saline Solution products after dangerous bacterial contamination led to serious and life-threatening infections in patients across the United States.

If you or a loved one developed an infection after using these products, you may be entitled to significant financial cash rewards from settlements for medical expenses, pain and suffering, and other damages.

Understanding the SteriCare Contamination Crisis

SteriCare Medical, Inc. manufactured and distributed sterile water and saline solution products contaminated with harmful bacteria, including Burkholderia cepacia and other pathogens. These products were intended for critical medical uses such as wound irrigation, inhalation therapy, and dilution of medications—applications that require absolute sterility to prevent infection.

What Products Are Affected by This Recall?

The recall encompasses multiple SteriCare product lines that were distributed to hospitals, surgical centers, and healthcare facilities nationwide:

• Sterile Water for Irrigation (various volumes)
• Sterile Saline Solution for Irrigation (various volumes)
• Sterile Water for Inhalation
• Sterile Saline for Inhalation
• Sterile Water for Injection

These products were used in vulnerable patient populations, including those undergoing surgery, receiving wound care, and patients with compromised immune systems who face the highest risk of severe complications from bacterial infections.

The Severity of Bacterial Contamination

Burkholderia cepacia and related bacterial species are particularly dangerous opportunistic pathogens that can cause:

• Bloodstream infections (bacteremia/sepsis)
• Respiratory tract infections and pneumonia
• Surgical site infections
• Urinary tract infections
• Wound infections that fail to heal
• Multi-organ system failure in severe cases

For immunocompromised patients, those with chronic lung conditions, and hospitalized individuals, these infections can be life-threatening and may require extended hospitalization, intensive antibiotic therapy, or additional surgical interventions.

Your Legal Rights: Who Can File a SteriCare Claim?

If you or a family member used SteriCare Sterile Water or Saline Solution products and subsequently developed a bacterial infection, you may have grounds for a product liability lawsuit. Eligible individuals include:

Patients who developed infections after exposure to SteriCare products during:

• Surgical procedures where contaminated irrigation solutions were used
• Wound care treatments involving contaminated sterile water or saline
• Respiratory therapy using contaminated inhalation solutions
• Any medical procedure requiring sterile water or saline solutions

Family members of patients who:

• Died as a result of infections caused by contaminated SteriCare products
• Suffered permanent injury or disability from these infections
• Required extensive medical treatment and ongoing care

Healthcare facilities that:

• Incurred costs from treating infection outbreaks
• Had to implement emergency protocols and product recalls
• Faced regulatory scrutiny or reputational damage

If you or someone you love has suffered any infections or other problems after using SteriCare Sterile Water & Saline Solution, we encourage you to take action now by calling our defective product lawyers at the Schmidt National Law Group at 1-800-631-5656, or contact us via the 100% secure online claims form on this page. We expect potentially large cash payouts.

Legal Grounds for SteriCare Lawsuits

Product liability claims against SteriCare Medical, Inc. may be based on multiple legal theories:

Manufacturing Defect Claims

SteriCare products were contaminated during the manufacturing process, rendering them dangerous and unsuitable for their intended sterile medical use. Manufacturers have a legal duty to ensure medical products meet safety standards and are free from contamination.

Failure to Warn Claims

If SteriCare knew or should have known about contamination risks but failed to adequately warn healthcare providers and patients, this constitutes a failure to warn—a recognized basis for product liability.

Breach of Warranty Claims

Sterile medical products come with an implied warranty that they are safe and suitable for their intended purpose. Bacterial contamination breaches this fundamental warranty.

Negligence Claims

Negligence may involve:

• Inadequate quality control and testing procedures
• Failure to maintain sterile manufacturing conditions
• Insufficient monitoring for bacterial contamination
• Delayed response to contamination reports

Types of Compensation Available

Victims of SteriCare’s contaminated products may recover several categories of damages:

Economic Damages

• Medical expenses: Hospital bills, emergency treatment, antibiotics, additional surgeries, ongoing care
• Lost wages: Income lost during recovery and treatment
• Future medical costs: Long-term treatment needs, rehabilitation, therapy
• Loss of earning capacity: If infections resulted in permanent disability

Non-Economic Damages

• Pain and suffering: Physical pain and emotional distress from infections
• Loss of quality of life: Inability to enjoy activities due to injury or disability
• Emotional trauma: Psychological impact of serious illness and complications
• Loss of consortium: Impact on family relationships and spousal companionship

Punitive Damages

In cases involving gross negligence or willful misconduct, courts may award punitive damages designed to punish the manufacturer and deter similar conduct. Given the severity of manufacturing and distributing contaminated sterile medical products, punitive damages may be appropriate in SteriCare cases.

The SteriCare FDA’s Class I Recall Classification

The FDA designated this as a Class I recall—the most serious type of recall indicating that use of these products may cause serious adverse health consequences or death. This classification strengthens legal claims by:

• Establishing that regulatory authorities recognized the severe danger
• Providing official documentation of product defects
• Demonstrating that the risk was significant enough to warrant the highest level of recall
• Creating a public record of the manufacturer’s failure to ensure product safety

Why Immediate Action Is Critical

Statute of Limitations: Every state has time limits for filing product liability lawsuits. These deadlines vary by state but typically range from 1-3 years from the date of injury or discovery of harm. Missing these deadlines means permanently losing your right to compensation.

Evidence Preservation: Medical records, product samples, and witness testimony become harder to obtain as time passes. Early action ensures critical evidence remains available.

Medical Documentation: Establishing the connection between SteriCare product use and subsequent infections requires thorough medical documentation. Acting promptly allows for proper medical evaluation and record-keeping.

Ongoing Harm: Some bacterial infections cause long-term complications. Early legal consultation ensures all potential damages—both current and future—are properly evaluated and included in your claim.

What to Expect When You Contact Schmidt National Law Group

Free Case Evaluation

Our experienced defective product attorneys will review your case at no cost and with no obligation. During this consultation, we will:

• Assess whether you have grounds for a claim
• Explain your legal rights and options
• Estimate the potential value of your case
• Answer your questions about the legal process

No Upfront Costs

We handle SteriCare cases on a contingency fee basis, meaning:

• You pay nothing upfront
• No attorney fees unless we recover compensation for you
• We advance all case costs during litigation
• You only pay if we win your case

Comprehensive Legal Representation

Our firm will handle every aspect of your case:

• Gathering medical records and evidence
• Consulting with medical experts about your infections and treatment
• Investigating the manufacturing defect and contamination
• Negotiating with insurance companies and defendants
• Filing lawsuits and litigating if necessary
• Fighting for maximum compensation on your behalf

Steps to Take If You Were Affected

1. Seek Immediate Medical Attention

If you suspect you may have developed an infection after exposure to SteriCare products, seek medical evaluation immediately. Inform your healthcare providers about potential exposure to contaminated sterile water or saline solutions.

2. Document Your Medical Treatment

Keep detailed records of:

• All medical appointments and treatments related to infections
• Diagnoses, test results, and culture reports showing bacterial infections
• Medications prescribed, especially antibiotics
• Hospital admissions and surgical procedures
• Medical bills and insurance statements

3. Identify Product Information

If possible, determine:

• Where your medical procedure took place
• When you received treatment involving sterile water or saline solutions
• Specific products used during your care (your healthcare provider may have this information)
• Lot numbers or product identifiers if available

Q: How do I know if my infection was caused by SteriCare products?

A: Medical records from your healthcare facility can indicate whether SteriCare sterile water or saline solutions were used during your treatment. If you developed a bacterial infection—particularly Burkholderia cepacia—after a medical procedure involving irrigation solutions or inhalation therapy, there may be a connection. Our attorneys can help investigate your case.

Q: What if my loved one died from an infection potentially related to SteriCare products?

A: Family members may file wrongful death claims seeking compensation for funeral expenses, loss of financial support, loss of companionship, and other damages. Immediate legal consultation is important to preserve your rights.

Q: Can I still file a claim if the infection occurred months ago?

A: Possibly, but time is critical. Statutes of limitations vary by state, and evidence becomes harder to obtain over time. Contact us immediately for a case evaluation to determine if you can still pursue compensation.

Q: What if I’m unsure whether SteriCare products were used in my treatment?

A: Our legal team can work with your healthcare providers to obtain records and determine which products were used during your care. Don’t let uncertainty prevent you from seeking a case evaluation.

Q: Will my case go to trial?

A: Many product liability cases settle before trial, but we prepare every case as if it will go to court. This approach often results in better settlement offers. If trial becomes necessary, we have extensive experience litigating complex product liability cases.

Why Choose Schmidt National Law Group

Our firm has extensive experience representing victims of defective medical products and dangerous pharmaceuticals. When you work with Schmidt National Law Group, you benefit from:

• Decades of combined experience in product liability litigation
• Proven track record of securing substantial settlements and verdicts
• Resources to take on large manufacturers and their insurance companies
• Compassionate, personalized attention to your case and your family’s needs
• National reach to represent clients across the United States

We understand the physical, emotional, and financial toll that serious bacterial infections take on patients and families. Our commitment is to hold negligent manufacturers accountable and secure the maximum compensation you deserve.

Take Action Now: Protect Your Rights

The SteriCare contamination crisis has affected patients across the country, causing serious infections, extended hospitalizations, and in some cases, tragic deaths. If you or a loved one suffered harm from contaminated SteriCare Sterile Water or Saline Solution products, you have legal rights—but time is limited.

Your consultation is free, you pay nothing unless we recover compensation for you, and all communications are completely confidential. Let our experienced defective product attorneys fight for the justice and compensation you deserve.

Page: SteriCare Sterile Water & Saline Solution Recall: Lawsuits and Settlement Claims updated on March 5, 2026.