Is Lamicel 20PK 3MM INTL Cervical dilator recalled?

Routine sterilization dose does not meet the required Sterility Assurance Level. Status: Voluntary: Firm initiated Initial Firm Notification: Letter Distribution: Affected product was only distributed in Japan.

Medium RiskFDA Device

Medtronic Xomed, Inc.: Routine sterilization dose does not meet the required Sterility Assurance Level.

Agency Publication Date: December 23, 2019

Affected Products

Product: Lamicel 20PK 3MM INTL Cervical dilator

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

Product: Lamicel 20PK 5MM INTL

UDI: 20885074749055; SPONGE 2203-501EX LAMICEL 20PK 5MM INTL; 2203-501EX; Lots 9642542, 9657414, 9657415, 9657416, 9677915, 9707331, 9707338, 9707334, 9712918

Product: Lamicel 10PK 10MM INTL

UDI: 20613994728917; SPONGE 2205-501EX LAMICEL 10PK 10MM INTL; 2205-501EX; Lots 9767987, 9806170

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84332

Status: Active

Manufacturer: Medtronic Xomed, Inc.

Manufactured In: United States

Units Affected: 3 products (29320 units; 307 packs; 6140 units; 10 packs; 100 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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