CLASS II Device recall · Reported 22 May 2013 · FDA Enforcement Report

Instat - Agent, Absorbable Hemostatic recalled by Integra LifeSciences

Integra LifeSciences is recalling Instat - Agent, Absorbable Hemostatic, Collagen Based Instat Mch is recommended for use, distributed nationwide in the US. The recall was initiated on 28 Mar 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1105177, 1105178 1110143, 1110227 1110228, 1110229 1110230, 1110233 1110786, 1110787 1111356, 1105179 111023 1, 1110232 1110785

Quantity recalled17, 616 boxes

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1288-2013
FDA event ID: 64778
Recalling firm: Integra LifeSciences, Plainsboro, NJ
Classification: Class II
Status: Terminated
Recall initiated: 28 Mar 2013
FDA classified: 10 May 2013
Reported: 22 May 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Device type: Surgical Instruments

Timeline

28 Mar 2013	Recall initiated by company
10 May 2013	Classified by FDA	+43 days
22 May 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Product as listed by the FDA

INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostatis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

Where it was distributed

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Which lots are affected?

1105177, 1105178 1110143, 1110227 1110228, 1110229 1110230, 1110233 1110786, 1110787 1111356, 1105179 111023 1, 1110232 1110785

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

20 other products · FDA event 64778

This product is part of a recall event; the main page for the event is Ora Plug Absorbable Collagen Wound Dressing recalled.

Reported	Class	Recall	Company	Reason	Where
22 May 2013	CLASS II	Ora Plug Absorbable Collagen Wound Dressing recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	HeliTape Absorbable Collagen Wound Dressing recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	Helitene Absorbable Collagen Hemostatic Sponge Helitene recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	OraMem Absorbable Collagen Membrane OraMem¿ Absorbable recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	DuraGen XS Dural Regeneration Matrix DuraGen XS Dural recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	NeuraWrap Nerve Protector NeuraWrap Nerve Protector recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	BioMend Absorbable Collagen Membrane BioMend¿ Absorbable recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	Layershield Adhesion Barrier Matrix Layershield Adhesion recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	Absorbable Collagen Sponge Provided As Intermediate recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	CollaCote Absorbable Collagen Wound Dressing recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	Dural Graft Matrix DuraGen¿ Dural Graft Matrix recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	OraTape Absorbable Collagen Wound Dressing recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	DuraGen Plus Dural Regeneration Matrix DuraGen Plus recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	Suturable DuraGen Dural Regenerative Matrix Suturable recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	Colla Tape Absorbable Collagen Wound Dressing recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	CollaPlug Absorbable Collagen Wound Dressing recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	HeliPlug Absorbable Collagen Wound Dressing recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	Helistat Absorbable Hemostatic,Collagen Based Helistat recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide

More recalls from Integra LifeSciences

All 246

Reported	Class	Recall	Company	Reason	Where
12 Mar 2025Device	CLASS II	Aurora Surgiscope System, Sterile recalled by Integra LifeSciences	Integra LifeSciences	Device Malfunction	Nationwide
19 Feb 2025Device	CLASS II	MediHoney¿ Gel MediHoney¿ Wound & Burn Dressing Gel recalled	Integra LifeSciences	Packaging Defects	Nationwide
29 Jan 2025Device	CLASS II	Codman Certas Plus Programmable Valve Inline Small Valve Only recalled	Integra LifeSciences	Packaging Defects	Nationwide
29 Jan 2025Device	CLASS II	Codman Certas Plus Programmable Valve Right Angle Valve Only recalled	Integra LifeSciences	Packaging Defects	Nationwide
29 Jan 2025Device	CLASS II	Codman Certas Plus Programmable Valve Inline Small Valve Only recalled	Integra LifeSciences	Packaging Defects	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide