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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98288

20 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 11, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Olympus Corporation of the Americas

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

20 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 20

Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.

Z-1438-2026
Recall number
Z-1438-2026
Initiated
November 11, 2025
Classification
Class II
Status
Ongoing
Quantity
29 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints of the ceramic tip of the resection sheath breaking have been received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints of the ceramic tip of the resection sheath breaking have been received.

Code information

Model: A22014A (UDI: 04042761020893) and A22014T (UDI: 04042761020909). All lots.

Distribution pattern

US Nationwide Distribution.

device · product 2 of 20

Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.

Z-1439-2026
Recall number
Z-1439-2026
Initiated
November 11, 2025
Classification
Class II
Status
Ongoing
Quantity
6,949 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints of the ceramic tip of the resection sheath breaking have been received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints of the ceramic tip of the resection sheath breaking have been received.

Code information

Model No. A22040A; UDI: 04042761029339; All Lots.

Distribution pattern

US Nationwide Distribution.

device · product 3 of 20

Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.

Z-1440-2026
Recall number
Z-1440-2026
Initiated
November 11, 2025
Classification
Class II
Status
Ongoing
Quantity
7,426 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints of the ceramic tip of the resection sheath breaking have been received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints of the ceramic tip of the resection sheath breaking have been received.

Code information

Model No. A22040T; UDI: 04042761029360; All Lots.

Distribution pattern

US Nationwide Distribution.

device · product 4 of 20

Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.

Z-1441-2026
Recall number
Z-1441-2026
Initiated
November 11, 2025
Classification
Class II
Status
Ongoing
Quantity
3,484 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints of the ceramic tip of the resection sheath breaking have been received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints of the ceramic tip of the resection sheath breaking have been received.

Code information

Model No. Model No. A22041A; UDI: 04042761020961; All Lots.

Distribution pattern

US Nationwide Distribution.

device · product 5 of 20

Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.

Z-1442-2026
Recall number
Z-1442-2026
Initiated
November 11, 2025
Classification
Class II
Status
Ongoing
Quantity
2,626 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints of the ceramic tip of the resection sheath breaking have been received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints of the ceramic tip of the resection sheath breaking have been received.

Code information

Model No. A22041T; UDI: 04042761020978; All Lots.

Distribution pattern

US Nationwide Distribution.

device · product 6 of 20

Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.

Z-1443-2026
Recall number
Z-1443-2026
Initiated
November 11, 2025
Classification
Class II
Status
Ongoing
Quantity
1,676 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints of the ceramic tip of the resection sheath breaking have been received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints of the ceramic tip of the resection sheath breaking have been received.

Code information

Model No. A22042A; UDI: 04042761020985; All Lots.

Distribution pattern

US Nationwide Distribution.

device · product 7 of 20

Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.

Z-1444-2026
Recall number
Z-1444-2026
Initiated
November 11, 2025
Classification
Class II
Status
Ongoing
Quantity
1,634 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints of the ceramic tip of the resection sheath breaking have been received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints of the ceramic tip of the resection sheath breaking have been received.

Code information

Model No. A22042T; UDI: 04042761020992; All Lots.

Distribution pattern

US Nationwide Distribution.

device · product 8 of 20

Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.

Z-1445-2026
Recall number
Z-1445-2026
Initiated
November 11, 2025
Classification
Class II
Status
Ongoing
Quantity
118 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints of the ceramic tip of the resection sheath breaking have been received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints of the ceramic tip of the resection sheath breaking have been received.

Code information

Model No. A22043A; UDI: 04042761021005; All Lots.

Distribution pattern

US Nationwide Distribution.

device · product 9 of 20

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

Z-1446-2026
Recall number
Z-1446-2026
Initiated
November 11, 2025
Classification
Class II
Status
Ongoing
Quantity
207 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints of the ceramic tip of the resection sheath breaking have been received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints of the ceramic tip of the resection sheath breaking have been received.

Code information

Model No. A22043T; UDI: 04042761021012; All Lots.

Distribution pattern

US Nationwide Distribution.

device · product 10 of 20

Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.

Z-1447-2026
Recall number
Z-1447-2026
Initiated
November 11, 2025
Classification
Class II
Status
Ongoing
Quantity
9 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints of the ceramic tip of the resection sheath breaking have been received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints of the ceramic tip of the resection sheath breaking have been received.

Code information

Model No. A2660; UDI: 04042761004176; All Lots.

Distribution pattern

US Nationwide Distribution.

device · product 11 of 20

Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.

Z-1448-2026
Recall number
Z-1448-2026
Initiated
November 11, 2025
Classification
Class II
Status
Ongoing
Quantity
899 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints of the ceramic tip of the resection sheath breaking have been received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints of the ceramic tip of the resection sheath breaking have been received.

Code information

Model No. A42011A; UDI: 04042761023658; All Lots.

Distribution pattern

US Nationwide Distribution.

device · product 12 of 20

Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.

Z-1449-2026
Recall number
Z-1449-2026
Initiated
November 11, 2025
Classification
Class II
Status
Ongoing
Quantity
91 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints of the ceramic tip of the resection sheath breaking have been received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints of the ceramic tip of the resection sheath breaking have been received.

Code information

Model No. A4741; UDI: 04042761006514; All Lots.

Distribution pattern

US Nationwide Distribution.

device · product 13 of 20

Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.

Z-1450-2026
Recall number
Z-1450-2026
Initiated
November 11, 2025
Classification
Class II
Status
Ongoing
Quantity
437 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints of the ceramic tip of the resection sheath breaking have been received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints of the ceramic tip of the resection sheath breaking have been received.

Code information

Model No. WA22017A; UDI: 04042761051514; All Lots.

Distribution pattern

US Nationwide Distribution.

device · product 14 of 20

Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.

Z-1451-2026
Recall number
Z-1451-2026
Initiated
November 11, 2025
Classification
Class II
Status
Ongoing
Quantity
1,141 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints of the ceramic tip of the resection sheath breaking have been received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints of the ceramic tip of the resection sheath breaking have been received.

Code information

Model No. WA22017T; UDI: 04042761051521; All Lots.

Distribution pattern

US Nationwide Distribution.

device · product 15 of 20

Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.

Z-1452-2026
Recall number
Z-1452-2026
Initiated
November 11, 2025
Classification
Class II
Status
Ongoing
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints of the ceramic tip of the resection sheath breaking have been received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints of the ceramic tip of the resection sheath breaking have been received.

Code information

Model No. A2666; UDI: 04042761004244; All Lots

Distribution pattern

US Nationwide Distribution.

device · product 16 of 20

Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.

Z-1453-2026
Recall number
Z-1453-2026
Initiated
November 11, 2025
Classification
Class II
Status
Ongoing
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints of the ceramic tip of the resection sheath breaking have been received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints of the ceramic tip of the resection sheath breaking have been received.

Code information

Model No. A2660T; UDI: 04042761004183; All Lots.

Distribution pattern

US Nationwide Distribution.

device · product 17 of 20

Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.

Z-1454-2026
Recall number
Z-1454-2026
Initiated
November 11, 2025
Classification
Class II
Status
Ongoing
Quantity
94 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints of the ceramic tip of the resection sheath breaking have been received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints of the ceramic tip of the resection sheath breaking have been received.

Code information

Model No. A37004A; UDI: 04042761023092; All Lots.

Distribution pattern

US Nationwide Distribution.

device · product 18 of 20

Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.

Z-1455-2026
Recall number
Z-1455-2026
Initiated
November 11, 2025
Classification
Class II
Status
Ongoing
Quantity
0 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints of the ceramic tip of the resection sheath breaking have been received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints of the ceramic tip of the resection sheath breaking have been received.

Code information

Model No. A2641; UDI: 04042761004060; All Lots.

Distribution pattern

US Nationwide Distribution.

device · product 19 of 20

Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.

Z-1456-2026
Recall number
Z-1456-2026
Initiated
November 11, 2025
Classification
Class II
Status
Ongoing
Quantity
0 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints of the ceramic tip of the resection sheath breaking have been received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints of the ceramic tip of the resection sheath breaking have been received.

Code information

Model No. A2642; UDI: 04042761004084; All Lots.

Distribution pattern

US Nationwide Distribution.

device · product 20 of 20

Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.

Z-1457-2026
Recall number
Z-1457-2026
Initiated
November 11, 2025
Classification
Class II
Status
Ongoing
Quantity
0 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints of the ceramic tip of the resection sheath breaking have been received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints of the ceramic tip of the resection sheath breaking have been received.

Code information

Model No. A2666T; UDI: 04042761004251; All Lots.

Distribution pattern

US Nationwide Distribution.