Medtronic Xomed, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0733-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Lamicel 20PK 3MM INTL Cervical dilator

Product Classification:

Class II

Date Initiated: November 13, 2019

Date Posted: January 1, 2020

Recall Number: Z-0733-2020

Event ID: 84332

Reason for Recall:

Routine sterilization dose does not meet the required Sterility Assurance Level.

Status: Ongoing

Product Quantity: 29320 units

Code Information:

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

Distribution Pattern:

Affected product was only distributed in Japan.

Voluntary or Mandated:

Voluntary: Firm initiated