Agency classClass IIOur severity:Severe FDA (Devices)·Z-1849-2016·Announced 2016-06-08

Curity All Purpose Sponges Recalled Due to Compromised Sterility

FDA is recalling Curity All Purpose Sponges due to compromised sterility from a barrier breach. The recall affects units distributed in the US and 20 other countries.

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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection from compromised sterility in a medical device.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm), Item Number 8047, manufactured by Covidien LLC. The recall is due to compromised sterility resulting from a breach of the product's barrier.

The affected lots range from 110000233562 through 120002651262X. A total of 2,418,560 units were distributed nationwide in the United States and in the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, and the United Kingdom.

Healthcare facilities and consumers should stop using the affected sponges immediately. Users should contact their supplier or the manufacturer for instructions on how to return or dispose of the product.

The recalled product

Product: Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number: 8047
Manufacturer: Covidien LLC
Category: Medical Device — Surgical Sponges
Hazard: sterility-breach
infection-risk
Affected units: 2,418,560

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 (1)

All lots beginning with 110000233562 through lot 120002651262X

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by Covidien LLC 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 13 products in this recall →

Same manufacturer · Covidien LLC

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Same hazard · sterility breach