Public recall detail

HEALON EndoCoat PRO

2026-08-06

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Health products Health product recall
Quick summary

Quick summary: HEALON EndoCoat PRO. Reason: Health product recall. Category: Health products. Date: 2026-08-06.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: HEALON EndoCoat PRO. Reason: Health product recall. Category: Health products. Date: 2026-08-06.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandJohnson & Johnson Surgical Vision, Inc.
ProductHEALON EndoCoat PRO
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82444

Affected products

ProductHEALON EndoCoat PRO
LotUA32371
Model10-3000-12
Serial numberUA32371
DescriptionHEALON EndoCoat PRO
ProductHEALON EndoCoat PRO
LotUA32303
Model10-3000-12
Serial numberUA32303
DescriptionHEALON EndoCoat PRO
ProductHEALON EndoCoat PRO
LotUP31203
Model10-3000-12
Serial numberUP31203
DescriptionHEALON EndoCoat PRO
ProductHEALON EndoCoat PRO
LotUP31205
Model10-3000-12
Serial numberUP31205
DescriptionHEALON EndoCoat PRO
ProductHEALON EndoCoat PRO
LotUA32292
Model10-3000-12
Serial numberUA32292
DescriptionHEALON EndoCoat PRO

Issue

Johnson & Johnson Surgical Vision, Inc. is issuing a voluntary recall notice for HEALON EndoCoat™ PRO to inform customers of reports involving difficulty with insertion of the ultra-thin 25g orange cannula. This notice is intended to communicate the potential risks associated with cannula insertion and provide additional clarification regarding insertion technique to support the safe and effective use of the product. This recall does not require removal or return of the product from the market. When used in accordance with the instructions provided in this notice, the product may continue to be used as intended.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Ophthalmology
CompaniesJohnson & Johnson Surgical Vision, Inc.31 Technology Drive, Irvine, California, United States, 92618
Recall date2026-07-30
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82444
Background{}
CompaniesJohnson & Johnson Surgical Vision, Inc.31 Technology Drive, Irvine, California, United States, 92618
AudiencesHealthcare
Source updated2026-08-06

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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