Food, drugs, devices › Integra LifeSciences Corp.
Device recall: CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification a
FDA enforcement event 94724 is a device recall by Integra LifeSciences Corp. of Princeton, NJ, initiated 29 May 2024 and classified Class II, with 1 product record.
FDA defines Class II as 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. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Integra LifeSciences Corp. has 79 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Integra LifeSciences Corp., Princeton, NJ.
Reason for recall
"Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment"
Distribution
"Nationwide Foreign: Argentina Australia Bangladesh Bangladesh Belgium Bolivia (Plurinational State of) Brazil Canada Chile China Costa Rica Dominican Republic (the) El Salvador Hong Kong India…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2167-2024 | CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue Catalog Number: C2600* *Note: you may see C2600P or C2600SRL on labeling. This notice is applicable for those SKUs as well | 2, 652 units | Class II | Ongoing | 3 Jul 2024 |
Context
Other enforcement events for Integra LifeSciences Corp.
All 79 events for Integra LifeSciences Corp.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Foreign: Argentina Australia Bangladesh Bangladesh Belgium Bolivia (Plurinational State of) Brazil Canada Chile China Costa Rica Dominican Republic (the) El Salvador Hong Kong India…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.