Medline wound care trays recalled due to sterility defect
Medline Industries is recalling Wound Care Trays due to potential lack of sterility in solution components. The recall affects 72,624 units distributed nationwide and internationally.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This product is classified as FDA Class I, which is a criterion for Critical severity per the rubric. FDA Class I recalls represent the agency's most serious classification level.
Plain-English summary
Medline Industries, LP is recalling Wound Care Trays (latex-free, REF DYND06002) manufactured using certain lots of Nurse Assist sterile components, including 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. The recall affects 72,624 units.
The recall was initiated due to the potential lack of sterility in the solution components, which could result in non-sterile solutions. The affected products were distributed nationwide in the United States, as well as to Puerto Rico, Canada, the United Arab Emirates, and Panama.
The recalled product
- Product
- Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE, REF DYND06002
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Wound care tray
- Affected units
- 72,624
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)
- REF DYND06002
- UDI/DI 40080196816645 (case)
- 10080196816644 (unit)
- Lot Numbers: 2022041290
- 2022051090
- 2022062090
- 2022081190
- 2022081790
- 2022101990
- 2022102090
- 2022111490
- 2023050390
- 2023050890
- 2023042890
- 2023050490
- 2023063090
- 2023062990
- 2023070390
- 2023072890
- 2023082590
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 · lack of sterility
See all →- HighRohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighRohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-07-29
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15