Olympus Corporation of the Americas: POWERSEAL Sealer and Divider Recalled Due to Potential Surgical Delays

Agency Publication Date: April 30, 2024

Summary

Olympus Corporation of the Americas is recalling 1,160 units of the POWERSEAL 5 mm Curved Jaw Sealer and Divider (Double Action) in 23 cm, 37 cm, and 44 cm lengths. The recall was initiated because the devices may experience a technical failure upon initial activation, resulting in an 'Incomplete Seal Cycle' message on the generator screen and a failure to deliver energy to the tool. This malfunction can cause an immediate stop in the device's ability to seal or cut tissue, leading to potential delays during surgical procedures. These medical devices were distributed worldwide, including nationwide across the United States, between March and April 2024.

Risk

If the device fails during a procedure, the surgeon may be unable to complete critical tissue sealing or dividing, resulting in an unexpected surgical delay while a replacement device is obtained and prepared.

What You Should Do

Identify if you have the affected POWERSEAL 5 mm Curved Jaw Sealer and Divider by checking the Model and Lot numbers on the product packaging. Affected models include PS-0523CJDA (23 cm), PS-0537CJDA (37 cm), and PS-0544CJDA (44 cm).
Check your specific Lot numbers against the following affected list: Lot CA182554 (for 23 cm model), Lots CA182543, CA182544, CA182546, CA182548, and CA191230 (for 37 cm model), and Lot CA179370 (for 44 cm model).
Verify the UDI-DI codes on the device labels: 00821925044531, 00821925044555, or 00821925044579.
Immediately contact your healthcare provider or Olympus Corporation of the Americas at 1-800-848-9024 for further instructions regarding the management of these devices and potential return or replacement procedures.
For additional information or to report adverse events, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer contact for device non-conformance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action

Model / REF:

PS-0523CJDA

UPC Codes:

00821925044531

Lot Numbers:

CA182554

Product: POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action

Model / REF:

PS-0537CJDA

UPC Codes:

00821925044555

Lot Numbers:

CA182543

CA182544

CA182546

CA182548

CA191230

Product: POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action

Model / REF:

PS-0544CJDA

UPC Codes:

00821925044579

Lot Numbers:

CA179370

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94375

Status: Active

Manufacturer: Olympus Corporation of the Americas

Sold By: Medical supply distributors; Direct hospital sales

Manufactured In: United States

Units Affected: 3 products (160 units: (20 units US); (140 units OUS); 850 units: (400 units US);(450 units OUS); 150 units: (20 units US); (130 units OUS))

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected POWERSEAL 5 mm Curved Jaw Sealer and Divider by checking the Model and Lot numbers on the product packaging. Affected models include PS-0523CJDA (23 cm), PS-0537CJDA (37 cm), and PS-0544CJDA (44 cm).

Check your specific Lot numbers against the following affected list: Lot CA182554 (for 23 cm model), Lots CA182543, CA182544, CA182546, CA182548, and CA191230 (for 37 cm model), and Lot CA179370 (for 44 cm model).

Verify the UDI-DI codes on the device labels: 00821925044531, 00821925044555, or 00821925044579.

Immediately contact your healthcare provider or Olympus Corporation of the Americas at 1-800-848-9024 for further instructions regarding the management of these devices and potential return or replacement procedures.

For additional information or to report adverse events, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action

Model / REF:

PS-0523CJDA

UPC Codes:

00821925044531

Lot Numbers:

CA182554

Product: POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action

Model / REF:

PS-0537CJDA

UPC Codes:

00821925044555

Lot Numbers:

CA182543

CA182544

CA182546

CA182548

CA191230

Product: POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action

Model / REF:

PS-0544CJDA

UPC Codes:

00821925044579

Lot Numbers:

CA179370

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94375

Status: Active

Manufacturer: Olympus Corporation of the Americas

Sold By: Medical supply distributors; Direct hospital sales

Manufactured In: United States

Units Affected: 3 products (160 units: (20 units US); (140 units OUS); 850 units: (400 units US);(450 units OUS); 150 units: (20 units US); (130 units OUS))

Distributed To: Nationwide