Medline Tracheostomy Care Kits and Trays Recalled Due to Sterility Concerns
Medline Industries is recalling tracheostomy care kits and trays due to potential lack of sterility in their component irrigation solutions. The non-sterile solutions pose a risk during patient care procedures.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This FDA Class I medical device recall meets the minimum severity threshold of 4 (Severe). Although no illnesses have been reported, potential sterility failure in irrigation solutions poses a direct infection risk in tracheostomy care.
Plain-English summary
Medline Industries, LP is recalling specific lots of tracheostomy care kits and trays: TRACH CARE KIT (REF DYND40589 and DYNDA3004), TRACHEOSTOMY CARE TRAY (REF DYND40650), and TRAY, TRACH, W/PCLNR, 14FR CATH N (REF DYND40594). These products contain component irrigation solutions (0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe) manufactured by Nurse Assist. A total of 991,744 units have been distributed.
The recall was initiated because the component irrigation solutions may lack sterility. Non-sterile solutions could contaminate the tracheostomy care procedure and potentially harm patients.
These kits and trays were distributed throughout the United States, including Puerto Rico, and internationally to Canada, the United Arab Emirates, and Panama. Consumers and medical facilities using these products should stop using them immediately and contact their supplier for return or replacement instructions. Specific lot numbers are listed in the FDA recall notice by product reference number.
The recalled product
- Product
- Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589; b) TRACH CARE KIT, REF DYNDA3004; c) TRACHEOSTOMY CARE TRAY, REF DYND40650; d) TRAY,TRACH,W/PCLNR,14FR CATH N, REF DYND40594
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 991,744
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 DYND40589
- UDI/DI 40080196032823 (case)
- 10080196032822
- (unit)
- Lot Numbers: 2022032590
- 2022033190
- 2022040190
- 2022040790
- 2022041490
- 2022041890
- 2022050690
- 2022052090
- 2022060990
- 2022062990
- 2022071390
- 2022063090
- 2022071590
- 2022071290
- 2022071890
- 2022080290
Distribution
Part of a larger recall action
This product is one of 49 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 49 products in this recall →Related recalls
Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield
See all →- CriticalIntubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
- SevereMedline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
- HighGood Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- HighSurgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- ModerateMedline Tracheostomy Convenience Kits Sterilization Calibration Recall
FDA (Devices) · 2026-05-13
- SevereMedline Tracheostomy Convenience Kits Recalled Over Sterilization Calibration Concerns
FDA (Devices) · 2026-02-25
- SevereMedline Tracheostomy Care Kits Recalled for Sharp Brush and Bristle Detachment
FDA (Devices) · 2024-01-03
- HighSterile Trach Pack procedure kits recalled due to blade puncture risk
FDA (Devices) · 2023-02-15
- HighSurgical Tracheostomy Kit Recalled Due to Perforated Outer Wrapping Compromising Sterility
FDA (Devices) · 2023-02-22
- ModerateMedline Recalls Sterile Piston Irrigation Syringe Trays Due to Packaging Defects
FDA (Devices) · 2019-09-04