Patients who developed serious infections after being treated with recalled SteriCare saline or sterile water products, and families of patients who died, are filing individual SteriCare lawsuits in federal court against manufacturer Nurse Assist, LLC and its distributors. As of early 2026, no class action has been certified and no settlements or verdicts have been reported, but cases are active and the pool of potential claimants is large: the FDA classified the November 2023 recall as Class I and logged roughly 120 adverse events in its MAUDE database by October 2024.1Motley Rice. SteriCare Lawsuit
Which Products and Dates Are Covered
The recall applies to Nurse Assist’s 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP products distributed between November 1, 2021, and September 18, 2023. Nurse Assist announced the recall on November 6, 2023, citing a “potential for a lack of sterility assurance” tied to compromised packaging seals.2U.S. Food & Drug Administration. Nurse Assist LLC Issues Recall of Sodium Chloride Irrigation USP and Sterile Water Irrigation USP Packaging ranged from 100 mL to 1,000 mL bottles, spray cans, prefilled syringes, and foil-lidded cups.
The SteriCare label is only one of many. Nurse Assist manufactured the same solutions for distribution under brand names including Cardinal Health, Covidien, McKesson, Medline, Halyard Owens Minor, MediChoice, SOL, Trudell, and Vyaire.3U.S. Food & Drug Administration. Recall of Certain Saline and Sterile Water Medical Products Associated With Nurse Assist The products were also packaged inside surgical, urology, wound care, tracheostomy, catheter, and feeding-tube kits assembled by other companies, so a patient may have been exposed without ever seeing the SteriCare name. If your care took place in that window, the product may have carried a different label on the outside of the tray.
Infections and Injuries Being Alleged
FDA testing identified Burkholderia cepacia complex (BCC) in the recalled products. BCC resists many common antibiotics and is especially dangerous for immunocompromised patients and those with chronic respiratory conditions such as cystic fibrosis.3U.S. Food & Drug Administration. Recall of Certain Saline and Sterile Water Medical Products Associated With Nurse Assist
Injuries reported by patients exposed to the recalled products include bloodstream infections and sepsis, surgical site infections, pneumonia and other respiratory infections, urinary tract infections, tissue necrosis leading to amputation, organ damage, and death.4AboutLawsuits.com. SteriCare Sodium Chloride Lawsuit Claims Recalled Saline Caused Infection, Wrongful Death Individual MAUDE reports describe outcomes at that severity. One patient with an ulcer wound became infected with Candida auris, which entered the bloodstream and caused fatal septic shock in November 2023.5U.S. Food & Drug Administration. MAUDE Adverse Event Report 18387517 Another patient who used the recalled saline on a wound developed gangrene and lost two toes to amputation.6U.S. Food & Drug Administration. MAUDE Adverse Event Report 19152619
Who Can File a Claim
Individuals who used any of the recalled saline or sterile water products after November 2021 and then developed a serious infection may be eligible to file. That includes patients whose wounds were cleaned with the solutions, patients who underwent surgery in which the products were used for irrigation, and patients who used the products at home for catheter flushing or wound care. Family members of patients who died from infections linked to the products may bring wrongful death claims.1Motley Rice. SteriCare Lawsuit
Statutes of limitations vary by state, and no uniform filing deadline applies across the litigation, so potential claimants who wait risk losing the right to sue regardless of how strong the underlying claim is.
Who Gets Sued
Filed complaints name Nurse Assist as the primary defendant and add distributors and kit assemblers depending on the chain of custody for the specific product. McKesson Medical-Surgical and Medline Industries have both appeared as co-defendants. In at least one case, the investment firms that acquired a 70 percent controlling interest in Nurse Assist in January 2023, including BPGC Management LP, Spinnaker International LLC, and R Investments, are named alongside the manufacturer.7AboutLawsuits.com. Nurse Assist SteriCare Lawsuit Infection Recalled Saline Solution Amputation
What the Current Lawsuits Look Like
Two cases illustrate the shape of the litigation.
Juliano v. Nurse Assist (New Jersey)
Matthew Juliano filed suit on July 18, 2025, in the U.S. District Court for the District of New Jersey, case number 1:25-cv-13512. He alleges that contaminated saline applied to his wounds during routine home care led to gas gangrene and necrotizing fasciitis diagnosed in June 2022. In November 2023 he underwent a below-the-knee amputation of his right leg, and during that surgery suffered a heart attack requiring a drug-eluting stent.7AboutLawsuits.com. Nurse Assist SteriCare Lawsuit Infection Recalled Saline Solution Amputation Defendants include Nurse Assist, AdaptHealth Corp., the three investment firms, and McKesson Medical-Surgical. The case is assigned to Chief Judge Renee Marie Bumb and remains active, with defendants filing answers and crossclaims through late 2025.8CourtListener. Juliano v. Nurse Assist, Case 1:25-cv-13512
McCaleb v. Nurse Assist (Alabama)
Linda McCaleb filed a wrongful death lawsuit on November 6, 2025, in the U.S. District Court for the Northern District of Alabama. She alleges that her husband, Dennis McCaleb, was treated at home with contaminated SteriCare sterile water while using a Foley catheter, ostomy bag, and PICC line after surgery for a bowel obstruction and hernia. He developed sepsis and multisystem organ failure and died February 2, 2024, from complications related to pancytopenia and septic shock. The suit names Nurse Assist, Medline Industries, and McKesson Medical-Surgical and brings claims for negligence, failure to warn, breach of implied warranty, and wrongful death.9AboutLawsuits.com. SteriCare Sterile Water Lawsuit Fatal Infection Contaminated Bottles
Legal Claims Being Brought
The complaints share a common set of theories: strict product liability, negligent design and manufacture, failure to warn (including a post-sale duty to warn), gross negligence, negligent misrepresentation, and breach of implied warranty. State-law claims track the forum. Juliano invokes the New Jersey Products Liability Act and the New Jersey Consumer Fraud Act.7AboutLawsuits.com. Nurse Assist SteriCare Lawsuit Infection Recalled Saline Solution Amputation The Alabama complaint proceeds under that state’s extended manufacturer’s liability doctrine.9AboutLawsuits.com. SteriCare Sterile Water Lawsuit Fatal Infection Contaminated Bottles
A recurring allegation across cases is delayed notification. Products distributed as early as November 2021 were not recalled until November 2023, and plaintiffs argue Nurse Assist knew or should have known about the contamination sooner.
Status of the Litigation
There is no certified class action. There is no multidistrict litigation consolidating the cases as of early 2026. What exists is a growing set of individual lawsuits in federal district courts, and no settlements or verdicts have been reported. Given the roughly 31,850 cases of affected product recorded in commerce and the breadth of the downstream kit recalls, the volume of filings is expected to continue rising.10U.S. Food & Drug Administration. Recall Z-0513-2024, Nurse Assist LLC