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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90788

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

Open FDA event record

Event summary

Timeline bucket
August 12, 2022
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

3 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 3

Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.

Z-1813-2022
Recall number
Z-1813-2022
Initiated
August 12, 2022
Classification
Class II
Status
Ongoing
Quantity
27 units (5/box) US; 83 units(5/box) OUS

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

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

An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment

Code information

UDI-DI: 00821925044531 Lot Numbers: CA191167 CA191168 CA191169 CA191170

Distribution pattern

Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA

device · product 2 of 3

Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.

Z-1814-2022
Recall number
Z-1814-2022
Initiated
August 12, 2022
Classification
Class II
Status
Ongoing
Quantity
231.4 units (5/box); 510 units (5/box) OUS

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

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

An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment

Code information

UDI-DI: 00821925044555 Lot Numbers: CA191233 CA191234 CA191235 CA233514 CA233515 CA233516 CA233517 CA233518 CA236206 CA236208 CA236213 CA236215 CA236216 CA236217 CA236220 CA236227 CA236228 CA236230 CA236238 CA236240 CA236243 CA236261 CA236272 CA236273 CA236276 CA236278 CA236290

Distribution pattern

Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA

device · product 3 of 3

Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.

Z-1815-2022
Recall number
Z-1815-2022
Initiated
August 12, 2022
Classification
Class II
Status
Ongoing
Quantity
44 units (5/box); 133 units (5/box) OUS

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

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

An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment

Code information

UDI-DI: 00821925044579 Lot Numbers: CA191182 CA191183 CA191184 CA191185 CA191186 CA236235 CA236237 FR230559

Distribution pattern

Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA