Medtronic Lamicel Cervical Dilators Recalled for Sterilization Defect
Medtronic Xomed is recalling Lamicel 20PK 3MM INTL Cervical Dilators because the sterilization dose did 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 is classified as FDA Class II, and the hazard involves a failure to meet Sterility Assurance Level, which is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medtronic Xomed, Inc. is recalling 29,320 units of Lamicel 20PK 3MM INTL Cervical Dilators. The recall was initiated because the routine sterilization dose used for these devices did not meet the required Sterility Assurance Level. This defect raises the potential risk that the devices may not be sterile.
The affected product was distributed only in Japan. The recall includes specific lot numbers and UDI codes, which are listed in the official FDA record. No illnesses or injuries have been reported in connection with this recall.
Healthcare providers and patients who have used or possess these specific lots of Lamicel Cervical Dilators should contact Medtronic Xomed for further instructions on how to return or dispose of the product. Consumers should not use the recalled devices until further notice.
The recalled product
- Product
- Lamicel 20PK 3MM INTL Cervical dilator
- Manufacturer
- Medtronic Xomed, Inc.
- Hazard
- Affected units
- 29,320
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: 20885074749024
- SPONGE 2202-501EX LAMICEL 20PK 3MM INTL
- 2202-501EX
- Lots 9646605
- 9651239
- 9651240
- 9651245
- 9667694
- 9667697
- 9667756
- 9669946
- 9686127
- 9686128
- 9688076
- 9693346
- 9693347
- 9693339
- 9775264
- 9799705
- 9799708
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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