Medtronic Lamicel Sponges Recalled for Sterilization Dose Deficiency
Medtronic Xomed is recalling Lamicel 10PK 10MM INTL sponges because the routine sterilization dose does not meet the required Sterility Assurance Level.
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: The recall involves a medical device with a sterilization defect that poses a risk of harm (infection) but does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Xomed, Inc. is recalling Lamicel 10PK 10MM INTL sponges. The recall involves 10 packs containing 100 units each, identified by UDI 20613994728917 and catalog number 2205-501EX. The affected lots are 9767987 and 9806170.
The reason for the recall is that the routine sterilization dose does not meet the required Sterility Assurance Level. This defect poses a risk that the medical devices may not be sterile.
The affected product was only distributed in Japan. No specific consumer actions are detailed in the source text beyond the recall notification.
The recalled product
- Product
- Lamicel 10PK 10MM INTL
- Manufacturer
- Medtronic Xomed, Inc.
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 (5)
- UDI: 20613994728917
- SPONGE 2205-501EX LAMICEL 10PK 10MM INTL
- 2205-501EX
- Lots 9767987
- 9806170
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Medtronic Xomed, 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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