Medline Medical Soft Liner Recall Due to Dimensional Variation
Medline Industries recalls 1.5L medical soft liners due to slight dimensional variations that may cause difficulty fitting into the outer canister. The recall affects 88,703 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a dimensional defect affecting product assembly. No injuries, illnesses, or hospitalizations have been reported. The hazard is functional difficulty rather than an acute safety risk.
Plain-English summary
Medline Industries, LP is recalling its 1.5L MED-SOFT LINER W/ 6MM X 1.8M TUB. & ADULT VC (ref OR53926) due to a slight dimensional variation in the product.
The dimensional variation has the potential to cause increased difficulty when fitting the device into its outer canister. This defect may affect proper assembly and use of the device.
The recall affects 88,703 units that were distributed worldwide, including throughout the United States, Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, and Singapore. Affected lot numbers are: 670220512, 670220609, 670220621, 670220629, 670220712, 670220803, 670220815, 670220914, and 670221009.
Consumers and healthcare facilities using this product should discontinue use of affected units. Contact Medline Industries for instructions on returning or replacing the product.
The recalled product
- Product
- 1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 88,703
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 (11)
- UDI/DI 40888277422279 (package)
- 0888277DC265NSKX (unit)
- Lot Numbers: 670220512
- 670220609
- 670220621
- 670220629
- 670220712
- 670220803
- 670220815
- 670220914
- 670221009
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 21 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.
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