Agency classClass IIOur severity:High FDA (Devices)·Z-1302-2013·Announced 2013-05-22

Integra Absorbable Collagen Sponge Recalled for Pyrogen Levels

Integra LifeSciences is recalling absorbable collagen sponges due to a process deviation that may have resulted in higher pyrogen levels than permitted.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of harm (pyrogens) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.

Plain-English summary

Integra LifeSciences Corporation is recalling 84,460 boxes of Absorbable Collagen Sponge. The product was provided as an intermediate to another company. The recall is due to a process deviation that may have caused the product lots to be released with higher levels of pyrogens than permitted by the product specifications.

The affected products were distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as countries such as the Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa. Specific lot codes are listed in the official recall documentation.

Consumers and healthcare providers should stop using the affected products and contact the manufacturer or their supplier for instructions on return or replacement. No specific illnesses or injuries are reported in the source text.

The recalled product

Product: Absorbable Collagen Sponge Provided As Intermediate to Another Company
Manufacturer: Integra LifeSciences Corporation
Category: Medical Device — Surgical Sponge
Hazard: pyrogen
Affected units: 84,460

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 (20)

1130055
1130057
1130228
1130229
1130388
1105192
1110821
1110822
1110987
1111023
1112020
1112379
1104815
1110841
1110842
1110843
1110953
1110954
1111022
1111821

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 21 recalled by Integra LifeSciences Corporation 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 21 products in this recall →

Same manufacturer · Integra LifeSciences Corporation

See all →

Moderate
Integra Meshed Dermal Regeneration Template Recalled for Calculation Error
FDA (Devices) · 2016-09-21
High
Integra Recalls Mayfield Ultra 360 Base Units Due to Locking Handle Failure
FDA (Devices) · 2015-02-18
Moderate
Integra Newdeal SURFIX Screws Recalled for Packaging Labeling Error
FDA (Devices) · 2014-06-11
High
Integra PANTA Arthrodesis Nail System Recalled for Screw Misalignment
FDA (Devices) · 2013-07-24
High
Integra Recalls BioMend Extend Membranes Due to Pyrogen Levels
FDA (Devices) · 2013-05-22

Same hazard · pyrogen