Molnlycke Recalls 9x15 Inch Utility Positioners Due to Metal Shavings
Molnlycke Health Care is recalling 204 units of 9x15" Medium Utility Positioners because they may contain metal shavings.
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 3/5 (High).
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: The recall involves a medical device with a potential physical hazard (metal shavings) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Molnlycke Health Care, Inc. is recalling 204 units of the 9x15" Medium Utility Positioner with Cover. The recall was initiated because the products may not meet specifications due to the possible presence of metal shavings.
The affected products were distributed domestically to facilities in Arkansas, Connecticut, Florida, Georgia, Iowa, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, North Carolina, Nebraska, New York, Ohio, Texas, Virginia, and Wisconsin. The specific recorder code for the affected units is 1400239.
Healthcare facilities should stop using the recalled products and contact Molnlycke Health Care for instructions on how to return or dispose of the units.
The recalled product
- Product
- 9x15" Medium Utility Positioner with Cover
- Manufacturer
- Molnlycke Health Care, Inc
- Affected units
- 204
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 (1)
- Recorder Code 1400239
Distribution
Part of a larger recall action
This product is one of 2 recalled by Molnlycke Health Care, Inc 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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