Medical Device Recall: Illuminated Laser Probe with Incorrect Expiration Date
Dutch Ophthalmic USA is recalling 13 boxes of Illuminated Stepped Laser Probe Curved devices due to a barcode labeling error. The barcode displays 2025-10-27 when the correct expiration date is 2024-10-01.
What this means for you
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 FDA recall of a sterile medical device used in ophthalmic surgery. The incorrect barcode expiration date could lead to use of expired devices, which may compromise sterility and safety. No illnesses or injuries have been reported, placing this at the risk-of-harm level without reported injury.
Plain-English summary
Dutch Ophthalmic USA, Inc. is recalling 13 boxes of Illuminated Stepped Laser Probe Curved devices (Product Code: 7510.ALC) due to an incorrect expiration date displayed on the barcode label. The barcode on the outer box shows an expiration date of 2025-10-27 when scanned, while the correct expiration date is 2024-10-01.
The recalled devices were distributed nationwide in California, Florida, Massachusetts, and Utah. The affected lot is Lot Number 039406, identified by Unique Device Identifier (UDI) 08717872016122.
These devices are designed for use in combination with 23G vitrectomy systems for ophthalmic surgery. An incorrect expiration date on the barcode could result in devices being used beyond their actual expiration, potentially affecting device sterility and effectiveness. The FDA classified this as a Class II recall.
The recalled product
- Product
- Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC
- Manufacturer
- Dutch Ophthalmic USA, Inc.
- Hazard
- labeling-error
- expired-device-risk
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 (1)
- Lot Number(s) 039406 Unique Device Identifier (UDI) 08717872016122
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03