Z-1446-2026Class II

Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic...

Name: Z-1446-2026 Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic...
Creator: Olympus Corporation of the Americas
Published: 2025-11-11
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2025-11-11 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications on 2025-11-11. FDA classified it as Class II and gives the reason as "Complaints of the ceramic tip of the resection sheath breaking have been received". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1446-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-11
Posted: 2026-02-20
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
Product code: FJL Resectoscope
Reason for recall: Complaints of the ceramic tip of the resection sheath breaking have been received.
FDA root cause: Under Investigation by firm
Action: An URGENT MEDICAL DEVICE CORRECTIVE ACTION notice was sent to consignees 1/6/2026. Consignees are instructed to ensure all personnel are familiar with the contents of the notification. Users are to adhere to the Inspection and Testing and Caution sections of the IFU for both the resection/inner sheath, as well as the Inspection Before Each Use section in the Resectoscope System Manual. Additional instructions include having an extra resection sheath and inspect during and after procedure for device fragments. Consignees are to retain a copy of the notification with the IFU. Consignees with any questions may contact Cynthia Ow at [email protected] or by phone at 947-999-3203.
Quantity in commerce: 207 units
Distribution: US Nationwide Distribution.
Product codes and lots: Model No. A22043T; UDI: 04042761021012; All Lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1446-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1438-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1439-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1440-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1441-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1442-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1443-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1444-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1445-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1446-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1447-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1448-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1449-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1450-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1451-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1452-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1453-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1454-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1455-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1456-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1457-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20

Product code FJL

K931995Class IIResectoscope SheathOlympus Corp. / cleared 1993-07-23

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)