MEDLINE Irrigation and Tracheostomy Kits Recalled for Potential Sterility Failure
MEDLINE Industries is recalling 385,028 units of suction catheter and tracheostomy care kits due to potential lack of sterility in Nurse Assist irrigation components. Affected kits were distributed in the US, Puerto Rico, Canada, UAE, and Panama.
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 mandates a minimum severity score of 4. The hazard—potential lack of sterility in irrigation solutions used in invasive medical procedures—poses significant risk of infection. No illnesses or deaths were reported in the source text.
Plain-English summary
MEDLINE Industries, LP (Northfield) is recalling 385,028 units of medical device kits and trays containing irrigation solution components manufactured by Nurse Assist. The recalled products include: (a) SUCTION CATH 10FR KIT W/SALINE (REF DYND41470SA, DYND41470SAH) and (b) TRACH CARE TRAY (REF DYNDA1931B, DYNDA1931BH).
The recall was initiated due to potential lack of sterility in three Nurse Assist components: 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. Non-sterile solutions used in medical procedures could result in infection or other complications.
The affected kits were distributed throughout the United States (including Puerto Rico), Canada, the United Arab Emirates, and Panama. Specific lot numbers are identified in the official FDA recall notice.
Customers and healthcare facilities who possess these products should verify their inventory against the reference numbers and lot numbers provided in the FDA recall notice and contact MEDLINE Industries for guidance on returns or replacement.
The recalled product
- Product
- MEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF DYND41470SA, DYND41470SAH; b) TRACH CARE TRAY, REF DYNDA1931B, DYNDA1931BH
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- lack-of-sterility
- 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 (19)
- a) REF DYND41470SA
- UDI/DI 40884389338705 (case)
- 10884389338704 (unit)
- Lot Numbers: 22HBD360
- 22IBA256
- 23ABU349
- 23CBG160
- 23GBV051
- 23IBT355
- REF DYND41470SAH
- UDI/DI - same as DYND41470SA
- b) REF DYNDA1931B
- UDI/DI 40195327277360 (case)
- 10195327277369 (unit)
- Lot Numbers: 22LMC118
- 22LMC126
- 23EMB086
- REF DYNDA1931BH
- UDI/DI - same as DYNDA1931B
Distribution
Distributed nationwide across the United States.
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