Food, drugs, devices › Medtronic Xomed, Inc.
Device recall: Lamicel 20PK 3MM INTL Cervical dilator
FDA enforcement event 84332 is a device recall by Medtronic Xomed, Inc. of Jacksonville, FL, initiated 13 Nov 2019 and classified Class II, with 3 product records.
FDA defines Class II as 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. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Medtronic Xomed, Inc. has 17 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medtronic Xomed, Inc., Jacksonville, FL.
Reason for recall
"Routine sterilization dose does not meet the required Sterility Assurance Level."
Distribution
"Affected product was only distributed in Japan."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0733-2020 | Lamicel 20PK 3MM INTL Cervical dilator | 29320 units | Class II | Ongoing | 1 Jan 2020 |
| Z-0734-2020 | Lamicel 20PK 5MM INTL | 307 packs; 6140 units | Class II | Ongoing | 1 Jan 2020 |
| Z-0735-2020 | Lamicel 10PK 10MM INTL | 10 packs; 100 units | Class II | Ongoing | 1 Jan 2020 |
Context
Other enforcement events for Medtronic Xomed, Inc.
All 17 events for Medtronic Xomed, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Routine sterilization dose does not meet the required Sterility Assurance Level."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Affected product was only distributed in Japan."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.