MEDLINE MDSALINE7Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10193489089356), received between Apr 28, 2026 and Aug 6, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

6 other recalls cover devices cleared under the same FDA submission (K083042, K112666); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 5, 2026Open, Classified

   Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.

   Z-1431-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Contamination /Decontamination Problem

  Customer reported an infection

  Patient problems: Unspecified Infection

  MAUDE report 50160971 ↗
• InjuryApr 28, 2026Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE USER, "THE PRODUCT WAS USED TO CLEAN A PRESSURE WOUND ON MY RIGHT FOOT BY HEALTHCARE PROFESSIONALS AND ME. THE PRESSURE WOUND WAS A RESULT OF A BONE FRACTURE. THE DOCTORS PRESCRIBED DIFFERENT ANTIBIOTICS A COUPLE OF TIMES TO CLEAR SKIN INFECTION AND THE IV ANTIBIOTIC INFUSION WAS PRESCRIBED TO CLEAR THE BONES INFECTION (30 DAYS LONG) AFTER THE SURGERY".

  Patient problems: Osteomyelitis

  MAUDE report 25022166 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083042, K112666. One submission often covers many models, so check the product and lot details in each record.

• Z-1435-2026 · Jan 5, 2026 · Open, Classified
  Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MJSALINE7
• Z-1433-2026 · Jan 5, 2026 · Open, Classified
  Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KI
• Z-1434-2026 · Jan 5, 2026 · Open, Classified
  Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
• Z-1432-2026 · Jan 5, 2026 · Open, Classified
  Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214
• Z-0513-2024 · Nov 6, 2023 · Open, Classified
  Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML STERILE SALINE BOTTLE/1020, 100ML STERILE SALINE BOTTLE/1022, 100ML STERILE WATER BOTTLE/1024, 100ML S
• Z-0511-2024 · Nov 6, 2023 · Open, Classified
  0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV