Z-2265-2023Class II

Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm...

Name: Z-2265-2023 Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm...
Creator: Olympus Corporation of the Americas
Published: 2023-05-15
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-05-15 / Open, Classified / root cause: design

FDA source

Olympus Corporation of the Americas began a recall of Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for... on 2023-05-15. FDA classified it as Class II and gives the reason as "Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2265-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-15
Posted: 2023-07-28
Recalling firm: OLYMPUS Corporation of the Americas
Product: Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-0382
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay
Root cause tag: design
FDA root cause: Component design/selection
Action: Olympus issued "URGENT - Medical Device Field Corrective Action" on 5/15/23. Letter states reason for recall, health risk and action to take: Olympus implemented a new internal component and has observed a reduction in complaints for the above-mentioned issue. However, to minimize the duration of potential procedure delay, Olympus is revising the Instruction for Use to add the below precaution statement: It is required to have additional Always-On Tip Tracked instruments available for all procedures as tracking may be lost when: Connecting the instrument to the SPiN Thoracic Navigation System Inserting and withdrawing the instrument from the working channel of the bronchoscope during procedure Navigating and sampling in tortuous patient anatomy Action steps to be taken by the end user: Our records indicate that you have purchased one or more of the affected products. Olympus requires you to take the following action: 1. Notify and ensure your users are knowledgeable about this additional precaution requiring additional instruments be available for all procedures. 2. Olympus requests that you acknowledge receipt of this letter by accessing the Olympus recall portal. a) Go to https://olympusamerica.com/recall. b) Enter the recall number 0425 c) Complete the form as instructed. 3. If you have distributed these devices outside your facility, please notify your customers of this matter immediately. Your notification to your customers may be enhanced by including a copy of this letter. Olympus requests that you report complaints associated with the use of this device, including patient injuries and adverse events, to our Technical Assistance Center (TAC) at 1-800-848-9024 (option 1 to report complaints). Contact (647) 999-3203 or at [email protected] for any additional information or support concerning this matter.
Quantity in commerce: 526.4 units
Distribution: Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: CN, DE, HK, IT, KR, SG, TH & TW.
Product codes and lots: UDI-DI: 00815686020590 Lot Numbers: 04992210324 and below

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2265-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2262-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-28
Z-2263-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-28
Z-2264-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-28
Z-2265-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-28
Z-2266-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-28
Z-2267-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-28
Z-2268-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-28
Z-2269-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-28

Product code JAK

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)