CLASS II ONGOING Device recall · Reported 6 Nov 2024 · FDA Enforcement Report

Surg Strp recalled by Integra LifeSciences

Integra LifeSciences is recalling Surg Strp 1-1, distributed nationwide in the US. The recall was initiated on 20 Sep 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 10381780515104, 20886704036620 Note: the same product code was distributed for a few years under JnJ under a transition agreement with Integra. Therefore, 2 UDI numbers are listed here for JnJ and for Integra. All unexpired products.

Quantity recalled2056

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-0253-2025
FDA event ID: 95432
Recalling firm: Integra LifeSciences, Princeton, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 20 Sep 2024
FDA classified: 29 Oct 2024
Reported: 6 Nov 2024
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

20 Sep 2024	Recall initiated by company
29 Oct 2024	Classified by FDA	+39 days
6 Nov 2024	Published in enforcement report	+8 days

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

Reason for recall

Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

Product as listed by the FDA

SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

Where it was distributed

Worldwide Distribution. US Nationwide, Canada Germany United Kingdom of Great Britain and Northern Ireland (the) Malta Italy Barbados Trinidad and Tobago Australia New Zealand Netherlands (the) Belgium France Ireland Switzerland Brunei Darussalam Bahamas (the) South Africa China Ecuador Korea (the Republic of) Czechia Kuwait Luxembourg French Guiana Mayotte Burundi Reunion Martinique Poland Costa Rica Japan Senegal Turkey Serbia Mexico Cambodia Spain Ghana Iceland Jersey Iraq Bahrain Lebanon Dominican Republic (the) Singapore Portugal Greece Austria C¿te d'Ivoire Palestine, State of Georgia Nigeria Slovenia Sweden Colombia United Arab Emirates (the) Saudi Arabia Qatar Hong Kong Oman Albania Panama Holy See (the) Kenya Pakistan Guernsey Morocco Chile Brazil Argentina Puerto Rico Rwanda Jordan Philippines (the) Hungary Romania Bolivia (Plurinational State of) Malaysia El Salvador Peru Lithuania Republic of North Macedonia Taiwan (Province of China) Israel Cyprus Bulgaria

Nationwide Georgia Puerto Rico

Questions about this recall

Is Surg Strp 1-1 recalled?

Yes. Integra LifeSciences recalled Surg Strp 1-1 on 20 Sep 2024. The recall is Class II and its status is Ongoing. Recall number Z-0253-2025.

Why was it recalled?

Which lots are affected?

UDI-DI: 10381780515104, 20886704036620 Note: the same product code was distributed for a few years under JnJ under a transition agreement with Integra. Therefore, 2 UDI numbers are listed here for JnJ and for Integra. All unexpired products.

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

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	Sterility	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	Lead & Heavy Metals	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	Sterility	Nationwide