Z-1959-2025Class I

Extended Tip Applicator, 15 CM, Box of 5

Name: Z-1959-2025 Extended Tip Applicator, 15 CM, Box of 5
Creator: Integra LifeSciences Corp. (NeuroSciences)
Published: 2025-05-22
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2025-05-22 / Open, Classified / root cause: sterility

FDA source

Integra LifeSciences Corp. (NeuroSciences) began a recall of Extended Tip Applicator, 15 CM, Box of 5 on 2025-05-22. FDA classified it as Class I and gives the reason as "Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1959-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-05-22
Posted: 2025-06-20
Recalling firm: Integra LifeSciences Corporation
Product: Extended Tip Applicator, 15 CM, Box of 5.
Product code: FMF Syringe, Piston
Reason for recall: Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Root cause tag: sterility
FDA root cause: Process change control
Action: An URGENT: VOLUNTARY MEDICAL DEVICE RECALL notification dated 5/22/25 was mailed to consignees for this product removal. Consignees are instructed to inspect their inventory for affected devices and quarantine any identified. The provided Acknowledgement form is to be completed and returned to Integra by email at [email protected] or by FAX at 1-609-750-4220. The provided notification is to be forwarded to users of affected devices and a copy retained for consignee records. A Return Material Authorization number will be generated upon receipt of the Acknowledgment Form for credit. Sales Representatives and Distributors are instructed to inspect their inventory for affected devices and quarantine any identified. The provided Acknowledgement form is to be completed and returned to Integra by email at [email protected] or by FAX at 1-609-750-4220. Distributors who further distributed affected devices are to forward the provided notification to their customers and collect Acknowledgement forms on their behalf to submit to Integra. Sales Representatives will be contacted by Post Market Quality to coordinate return of devices. Consignees with any questions are to contact Customer Service by phone at 1-800-654-2873 or by email at [email protected]. Additional communications were made to customers on 7/10/25 and 7/18/25 informing them that expired devices are also subject to this recall and should be disposed of.
Quantity in commerce: 2,524 units
Distribution: Domestic: Nationwide Distribution; Foreign: Canada, Japan, Australia, New Zealand, Taiwan (Province of China), Mexico, Colombia, Dominican Republic (the), Singapore, Mongolia, Hong Kong, Chile, Argentina, Puerto Rico, El Salvador, Guatemala, Korea (the Republic of), Peru, Costa Rica, Panama, From Belgium, distributed to: Austria, Belgium, Cyprus, Czechia, France, Georgia, Germany, Greece, Hungary, Iran (Islamic Republic of), Ireland, Italy, Jordan, Malta, Netherlands (the), Nigeria, Palestine, State of, Portugal, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey.
Product codes and lots: Model/Catalog Number: 205115; UDI: 10381780000150; All Lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1959-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1958-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-07-02	2025-06-20
Z-1959-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-07-02	2025-06-20
Z-1960-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-07-02	2025-06-20

Product code FMF

K091315Class IICovidien Extended Tip ApplicatorConfluent Surgical,Inc / cleared 2009-06-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)