POWERSEAL surgical sealer malfunction causes incomplete seal cycle
Olympus POWERSEAL surgical sealers may fail to deliver energy upon activation, resulting in incomplete seal cycles and surgical delays. Affected devices display an error tone and message instead of completing the sealing function.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a device that fails to deliver energy to complete the sealing function during surgical use. No injuries or deaths are reported in the source material. Per the rubric, Class II recalls with risk-of-harm but no reported injuries score as High (3).
Plain-English summary
Olympus Corporation of the Americas is recalling 850 units of the POWERSEAL 5 mm, 37 cm Curved Jaw Sealer and Divider, Double Action (Model PS-0537CJDA) surgical instrument. The devices are indicated for use in general surgery and surgical specialties including urologic, colorectal, bariatric, vascular, thoracic, and gynecologic procedures.
Upon initial activation, the recalled units fail to deliver energy and do not complete the seal cycle. Instead, the devices display an error tone and message on the generator screen, resulting in delays during surgical procedures.
The affected units were distributed worldwide, with 400 units shipped to the United States and 450 units shipped internationally to Australia, Canada, Hong Kong, and South Korea. The recalled lot numbers are CA182543, CA182544, CA182546, CA182548, and CA191230.
Users of affected devices should contact Olympus Corporation of the Americas for information regarding repair or replacement. The FDA has classified this as a Class II recall.
The recalled product
- Product
- POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0537CJDA
- Manufacturer
- Olympus Corporation of the Americas
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI-DI: 00821925044555 Lot numbers: CA182543
- CA182544
- CA182546
- CA182548
- CA191230
Distribution
Part of a larger recall action
This product is one of 3 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Olympus Corporation of the Americas
See all →- ModerateOlympus DisplayPort Cable Recalled for Video Dropout Risk
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Foroblique Telescope Recalled for Sterilization Labeling Discrepancy
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Lateral Telescope 70 Recalled for Sterilization Labeling Discrepancies
FDA (Devices) · 2026-10-07
- ModerateOlympus Endoscopic Balloon Dilator Recalled for Incorrect Inflation Chart Label
FDA (Devices) · 2026-09-30
- SevereOlympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30
Same hazard · device malfunction
See all →- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alert issues
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Convenience Kits Containing CONMED AirSeal Access Ports
FDA (Devices) · 2026-10-21
Similar recalls
- HighOlympus POWERSEAL 5MM Electrosurgical Sealer Recalled Due to Loose Retention Ring
FDA (Devices) · 2022-10-05
- HighOlympus POWERSEAL surgical sealer recalled for loose retention ring defect
FDA (Devices) · 2022-10-05
- HighOlympus POWERSEAL Electrosurgical Device Recalled for Retention Ring Malfunction
FDA (Devices) · 2022-10-05
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighOlympus THUNDERBEAT surgical instrument blue seal button may fail to return to neutral
FDA (Devices) · 2023-10-18
- HighSurgical instrument button malfunction may extend operative time
FDA (Devices) · 2023-10-18