MEDLINE Enzymatic Cleaning Sponges Recalled Due to Microbial Contamination
MEDLINE Polyurethane Foam Enzymatic Cleaning Sponges (REF DYK1000TSE) are being recalled due to microbial contamination identified on certain lots. The affected product was distributed in the US and Panama.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall is classified as FDA Class II and involves microbial contamination on a medical device. No illnesses or injuries have been reported. Per the severity rubric, this qualifies as High (3) as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
MEDLINE INDUSTRIES, LP is recalling MEDLINE Polyurethane Foam Enzymatic Cleaning Sponges (REF DYK1000TSE) distributed in the United States and Panama.
The FDA received sporadic reports of discoloration on the foam sponge in certain lots. The discoloration has been identified as microbial contamination. Approximately 500 boxes of 100 units each are affected.
The recalled product
- Product
- MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device
- Hazard
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 (2)
- DI: (01) 40888277367358
- MM is the number of the month of production
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 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 5 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 · microbial contamination
See all →- HighMedline IV Start Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline Blood Culture Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline Eye and Cataract Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09