Medline Irrigation Kits and Packs Recalled for Sterility Defect
Medline Industries recalls 279 irrigation and saline kits, trays, and packs due to potential lack of sterility in components used to manufacture them. Solutions may be non-sterile.
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: The FDA has classified this as a Class I recall due to the potential lack of sterility in irrigation solutions. Although no reported illnesses or deaths are documented in the recall notice, the potential for infection from non-sterile irrigation solutions in medical procedures justifies the Severe rating.
Plain-English summary
Medline Industries, LP has issued a recall of 279 units of irrigation and saline kits, trays, and packs due to issues with the components used to manufacture them. The recall affects three product lines: D&C CDS (REF CDS983911J), D&C PACK (REF DYNJ67214F), and D&C PACK (REF DYNJ67214G). These products were manufactured using specific lots of Nurse Assist components, including 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. Nurse Assist issued a recall of these components due to a potential lack of sterility, which could result in the solutions being non-sterile.
The recalled products have been distributed nationwide throughout the United States, Puerto Rico, Canada, United Arab Emirates, and Panama. Specific lot numbers for each product line have been identified as part of this recall.
Non-sterile irrigation and saline solutions could pose a risk of infection when used in medical procedures.
The recalled product
- Product
- Medline Kits, trays, and packs labeled as follows: a) D&C CDS, REF CDS983911J; b) D&C PACK, REF DYNJ67214F; c) D&C PACK, REF DYNJ67214G
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 279
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 CDS983911J
- UDI/DI 40193489402668 (case)
- 10193489402667 (unit)
- Lot Numbers: 22EBU168
- 22KBI115
- 22LBL299
- 22NBD200
- 22NBF154
- 23ABE617
- 23ABU424
- 23CBT642
- 23IBM022
- 23JBC180
- b) REF DYNJ67214F
- UDI/DI 40195327277803 (case)
- 10195327277802 (unit)
- Lot Numbers: 22LBT250
- 23BBM551
- 23CBS078
- c) REF DYNJ67214G
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 →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- ModerateMedline Recalls Sterile Piston Irrigation Syringe Trays Due to Packaging Defects
FDA (Devices) · 2019-09-04
- ModerateMedline Non Sterile I&D Kit Procedure Kits Recalled for Leaking Bottles
FDA (Devices) · 2025-05-07
- ModerateMedline procedure kits recalled for leaking sterile water and saline bottles
FDA (Devices) · 2025-05-07
- SevereSterile Water and Saline Products Recalled for Lack of Sterility Assurance
FDA (Devices) · 2023-12-27
- SevereMedline Recalls Non-Sterile Urinalysis Kit Specimen Containers
FDA (Devices) · 2024-11-20
- HighMedline Convenience Kits Recalled for Sterilization Equipment Calibration
FDA (Devices) · 2026-05-13