CLASS II ONGOING Device recall · Reported 29 Apr 2026 · FDA Enforcement Report

CUSA Clarity C7000 Console recalled by Integra LifeSciences Corp.

Integra LifeSciences Corp. (NeuroSciences) is recalling CUSA Clarity C7000 Console, distributed nationwide in the US. The recall was initiated on 6 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel: C7000; UDI: 10381780126232; Serial Numbers: CHA1902101IE, CHA2001301IE, CHA2001401IE, CHA2002301IE, CHA2202301IE, CHA2305101IE, CHA2305401IE, CHA2307001IE, CHA2402201IE, CHB1711001IE, CHB1723601IE, CHB2000801IE, CHB2100901IE, CHB2301401IE, CHB2500101IE, CHC1800601IE, CHC1902601IE, CHC1902701IE, CHC2001201IE, CHD1705801IE, CHD1707101IE, CHD1801001IE, CHD1801101IE, CHD1902501IE , CHE1707201IE, CHE1707301IE, CHE2203301IE, CHE2204001IE, CHE2301001IE , CHE2305001IE, CHE2502901IE, CHE2503101IE, CHE2503201IE, CHE2503401IE, CHE2503701IE, CHF1701401IE, CHF1702701IE, CHF2100701IE, CHF2303701IE, CHF2305401IE, CHG1700101IE, CHG1700801IE, CHG1902401IE, CHG2000201IE, CHG2000301IE, CHG2204101IE, CHG2402301IE, CHG2502801IE, CHG2506001IE, CHH1802901IE, CHH2402801IE, CHH2500601IE, CHJ2001101IE, CHJ2001301IE , CHJ2301201IE, CHJ2304601IE, CHK1700801IE, CHK1702301IE, CHK1703001IE, CHK2402601IE, CHK2403401IE, CHK2404101IE, CHL1701701IE, CHL1900201IE, CHL2102901IE , CHL2103001IE, CHL2301301IE, CHL2302001IE, CHL2302101IE, CHL2403301IE, CHM1901901IE, CHM2100101IE, CHM2101601IE, CHM2200201IE, CHM2200301IE, CHM2200501IE, CHM2300701IE, CHM2402101IE.

Quantity recalled78 units

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-1828-2026
FDA event ID: 98476
Recalling firm: Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 6 Mar 2026
FDA classified: 17 Apr 2026
Reported: 29 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

6 Mar 2026	Recall initiated by company
17 Apr 2026	Classified by FDA	+42 days
29 Apr 2026	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

Software issue that renders the touch screen unresponsive.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.

Where it was distributed

Worldwide - US Nationwide distribution in the states of MI & NY. The countries of Belgium, China, Czechia, Dubai, Finland, France, Germany, Italy, Japan, Luxembourg, Netherlands. Poland, Spain, Switzerland, Tunisia & United Kingdom.

Nationwide Michigan New York

Questions about this recall

Why was it recalled?

Software issue that renders the touch screen unresponsive.

Which lots are affected?

Model: C7000; UDI: 10381780126232; Serial Numbers: CHA1902101IE, CHA2001301IE, CHA2001401IE, CHA2002301IE, CHA2202301IE, CHA2305101IE, CHA2305401IE, CHA2307001IE, CHA2402201IE, CHB1711001IE, CHB1723601IE, CHB2000801IE, CHB2100901IE, CHB2301401IE, CHB2500101IE, CHC1800601IE, CHC1902601IE, CHC1902701IE, CHC2001201IE, CHD1705801IE, CHD1707101IE, CHD1801001IE, CHD1801101IE, CHD1902501IE , CHE1707201IE, CHE1707301IE, CHE2203301IE, CHE2204001IE, CHE2301001IE , CHE2305001IE, CHE2502901IE, CHE2503101IE, CHE2503201IE, CHE2503401IE, CHE2503701IE, CHF1701401IE, CHF1702701IE, CHF2100701IE, CHF2303701IE, CHF2305401IE, CHG1700101IE, CHG1700801IE, CHG1902401IE, CHG2000201IE, CHG2000301IE, CHG2204101IE, CHG2402301IE, CHG2502801IE, CHG2506001IE, CHH1802901IE, CHH2402801IE, CHH2500601IE, CHJ2001101IE, CHJ2001301IE , CHJ2301201IE, CHJ2304601IE, CHK1700801IE, CHK1702301IE, CHK1703001IE, CHK2402601IE, CHK2403401IE, CHK2404101IE, CHL1701701IE, CHL1900201IE, CHL2102901IE , CHL2103001IE, CHL2301301IE, CHL2302001IE, CHL2302101IE, CHL2403301IE, CHM1901901IE, CHM2100101IE, CHM2101601IE, CHM2200201IE, CHM2200301IE, CHM2200501IE, CHM2300701IE, CHM2402101IE.

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.

More recalls from Integra LifeSciences Corp. (NeuroSciences)

All 31

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	OmniTract Surgical Retractor System recalled	Integra LifeSciences Corp. (NeuroSciences)	Sterility	Nationwide
20 May 2026Device	CLASS II	Codman CerebroFlo EVD Catheter with Endexo Technology recalled	Integra LifeSciences Corp. (NeuroSciences)	Other	Nationwide
22 Apr 2026Device	CLASS II	Cytal Wound Matrix 2-Layer cm. Product ID: WSM1015 recalled	Integra LifeSciences Corp. (NeuroSciences)	Other	Nationwide
22 Apr 2026Device	CLASS II	Cytal Wound Matrix 2-Layer cm. Product ID: WSM0710 recalled	Integra LifeSciences Corp. (NeuroSciences)	Other	Nationwide
22 Apr 2026Device	CLASS II	Cytal Burn Matrix cm. Product ID: BMM0710 recalled	Integra LifeSciences Corp. (NeuroSciences)	Other	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