Lamicel 20PK 3MM INTL Cervical dilator (Medtronic Xomed, Inc.) – routine sterilization dose does not m... (2019)
Class II: 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 recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Lamicel 20PK 3MM INTL Cervical dilator
Brand
Medtronic Xomed, Inc.
Lot Codes / Batch Numbers
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, 9811174, 9812616, 9819177, 9819513, 9819516, 9851438
Products Sold
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, 9811174, 9812616, 9819177, 9819513, 9819516, 9851438
Medtronic Xomed, Inc. is recalling Lamicel 20PK 3MM INTL Cervical dilator due to Routine sterilization dose does not meet the required Sterility Assurance Level.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Routine sterilization dose does not meet the required Sterility Assurance Level.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Mar 8, 2026