Medical Device Liner Recalled for Dimensional Variation Affecting Fit
Medline Industries has recalled 316,125 units of its MED-SOFT Single Liner with Solidifier due to a dimensional variation that may cause difficulty when inserting the product into the outer canister.
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: FDA Class II recall with a dimensional fitting defect. The source does not report any injuries or illnesses, and the hazard is functional difficulty rather than inherently harmful, making it a moderate-severity precautionary recall.
Plain-English summary
Medline Industries, LP has recalled the 1.5L MED-SOFT Single Liner with Solidifier (REF OR1920PG) due to a dimensional variation in the product. This variation has the potential to increase difficulty when fitting the liner into the outer canister.
The recall affects 316,125 units distributed worldwide, including throughout the United States and in Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, and Singapore. The affected product can be identified by lot numbers including 670220511, 670220622, 670220628, 670220706, 670220720, 670220801, 670220805, 670220907, 670220912, 670221020, 670221115, 670221128, 670221205, 670221213, 670221219, 670221223, 670230105, 670230213, 670230308, 670230322, 670230424, 670230530, and 670230601.
The recalled product
- Product
- 1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device
- Affected units
- 316,125
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)
- UDI/DI 20888277660103 (package)
- 0888277DC265NSKX (unit)
- Lot Numbers: 670220511
- 670220622
- 670220628
- 670220706
- 670220720
- 670220801
- 670220805
- 670220907
- 670220912
- 670221020
- 670221115
- 670221128
- 670221205
- 670221213
- 670221219
- 670221223
- 670230105
- 670230213
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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