Medtr: Lamicel 10PK 10MM INTL Sterility Risk Recall
Medtronic Xomed recalls Lamicel 10PK 10MM INTL due to inadequate sterilization. Affected units have specific UDI and lot numbers. Consumers should contact for details.
Lower-risk recall
Routine sterilization dose does not meet the required Sterility Assurance Level.
Contact the company
What happened, in plain English
Medtronic Xomed is recalling Lamicel 10PK 10MM INTL surgical sponges because their sterilization process doesn't meet safety standards. This could lead to infections if used in medical procedures. Read more at govinfonow.com/recall/66531-medtr-lamicel-10pk-10mm-intl-sterility-risk-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/66531-medtr-lamicel-10pk-10mm-intl-sterility-risk-recall · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0735-2020
Cite this page
“Medtr: Lamicel 10PK 10MM INTL Sterility Risk Recall.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/66531-medtr-lamicel-10pk-10mm-intl-sterility-risk-recall. Based on FDA recall #Z-0735-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0735-2020%22&limit=1).
Why it’s dangerous
The sponges may not be properly sterilized, which can lead to infections during medical procedures. This happens because the sterilization process doesn't meet the required safety standards.
Who’s affected
Healthcare professionals using these sponges in surgeries or medical procedures are most at risk. Patients receiving surgery with these sponges could face infection.
How to tell if you have this one
Check for the UDI number 20613994728917 or lot numbers 9767987 and 9806170 on the packaging. The product name is Lamicel 10PK 10MM INTL.
- Brand
Medtronic Xomed- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Affected product was only distributed in Japan.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0733-2020 | 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 | 29320 units |
| Z-0734-2020 | 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 | 307 packs; 6140 units |
| Z-0735-2020 | Lamicel 10PK 10MM INTL; UDI: 20613994728917; SPONGE 2205-501EX LAMICEL 10PK 10MM INTL; 2205-501EX; Lots 9767987, 9806170 | 10 packs; 100 units |
What to do — step by step
Contact Manufacturer
Reach out to Medtronic Xomed for specific instructions on how to handle affected units.
How this recall unfolded
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0735-2020 (November 13, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0735-2020 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.