Agency classClass IIOur severity:Severe FDA (Devices)·Z-0734-2020·Announced 2020-01-01

Medtronic Lamicel Sponges Recalled for Sterilization Dose Deficiency

Medtronic Xomed is recalling Lamicel 20PK 5MM INTL sponges because the routine sterilization dose does not meet the required Sterility Assurance Level.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential sterility failures in medical devices.

Plain-English summary

Medtronic Xomed, Inc. is recalling Lamicel 20PK 5MM INTL sponges. The recall involves 307 packs, totaling 6,140 units. The affected product was distributed only in Japan.

The reason for the recall is that the routine sterilization dose does not meet the required Sterility Assurance Level. This deficiency means the sterilization process may not have been sufficient to ensure the sponges are sterile.

The affected lots are 9642542, 9657414, 9657415, 9657416, 9677915, 9707331, 9707338, 9707334, and 9712918. The UDI for the product is 20885074749055. Healthcare providers and facilities in Japan should check their inventory for these specific lot numbers and stop using the affected sponges.

The recalled product

Product: Lamicel 20PK 5MM INTL
Manufacturer: Medtronic Xomed, Inc.
Category: Medical Device — Surgical Sponges
Hazard: sterility-failure
infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

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

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by Medtronic Xomed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Medtronic Xomed, Inc.

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Same hazard · sterility failure