Medline Medical Kits Recalled for Potential Sterility Defect
Medline Industries is recalling multiple surgical and critical care kits due to a potential lack of sterility in component solutions (sodium chloride irrigation, sterile water for irrigation, and saline flush syringes). Non-sterile solutions could expose patients to infection.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall, which requires a minimum severity score of 4. The potential loss of sterility in irrigation solutions used in critical care procedures creates a risk of serious infection. No illnesses or injuries have been reported, preventing classification as Critical.
Plain-English summary
Medline Industries, LP is recalling multiple surgical and critical care kits and trays manufactured using specific lots of Nurse Assist component solutions: 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. The affected products include Dialysis Fistula Kits, Endo Kits, VAD Kits, LVAD Driveline Management Kits, Pacemaker Packs, Pericardial Kits, and Percutaneous ECMO Kits, among others identified in the recall notice.
Nurse Assist identified a potential lack of sterility in the component solutions used in these kits. Non-sterile irrigation solutions could compromise patient safety in dialysis, cardiac, vascular access, and other invasive medical procedures by creating a risk of infection.
The affected kits and trays were distributed nationwide throughout the United States, including Puerto Rico, as well as to Canada, the United Arab Emirates, and Panama. Healthcare facilities and suppliers in these regions may have received affected products.
No illnesses or injuries have been reported to date in connection with this recall. Consumers and healthcare facilities that have received affected kits should contact Medline Industries or their healthcare provider to verify whether their products are included in this recall and for guidance on next steps.
The recalled product
- Product
- MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE1346D, c) ENDO KIT, REF DYKE1892A, d) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648G, e) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I, f) FREQUENT DAILY VAD, REF DYN
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-defect
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) REF DYNDC3106
- UDI/DI 40193489913270 (case)
- 10193489913279 (unit)
- Lot Numbers: 21LBT706
- 22CBE273
- b) REF DYKE1346D
- UDI/DI 40195327114085 (case)
- 10195327114084 (unit)
- Lot Numbers: 22GBO510
- 23BBG861
- 23CBM313
- 23EBN617
- 23FBU655
- 23GBR877
- 23IBH963
- c) REF DYKE1892A
- UDI/DI 40195327430963 (case)
- 10195327430962 (unit)
- Lot Numbers: 10195327430962
- d) REF DYKE1648G
Distribution
Distributed nationwide across the United States.
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