Medline Pill Splitters recalled for unhinged lid exposing sharp blade
Medline is recalling over 840,000 pill splitters due to a defect where the product lid can come unhinged, exposing a sharp blade and posing a laceration risk.
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: FDA Class II device with risk of laceration from exposed blade. No reported injuries or illnesses to date; the hazard is clear but actual harm remains theoretical, meeting the criterion for risk-of-harm products without reported injury.
Plain-English summary
Medline Industries, LP is recalling approximately 840,087 Medline Pill Splitters (Model Number NON135000) due to a manufacturing defect. The product lid, which houses a blade, can come unhinged from the base, exposing the sharp blade.
The affected pill splitters were distributed worldwide, including the United States and the countries of Canada, Singapore, Panama, and Hong Kong.
This defect poses a risk of laceration to users who may contact the exposed blade. Although no injuries have been reported to date, consumers should stop using these devices immediately.
Consumers who have purchased affected pill splitters should discontinue use and contact Medline Industries for instructions on returning or replacing the product. The recalled lot numbers are: 50920060001, 50920080001, 50920110001, 50921030001, 50921040001, 50921050001, 50921060001, 50921080001, 50921090001, 50921100001, 50921110001, 50921120001, and 50922020001.
The recalled product
- Product
- Medline Pill Splitters; 1 each/box; 144 boxes/carton
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 840,087
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 (15)
- Model Number: NON135000
- UDI/DI:8019673489
- Lot Numbers: 50920060001
- 50920080001
- 50920110001
- 50921030001
- 50921040001
- 50921050001
- 50921060001
- 50921080001
- 50921090001
- 50921100001
- 50921110001
- 50921120001
- 50922020001
Distribution
Distributed nationwide across the United States.
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