Agency classClass IIOur severity:High FDA (Devices)·Z-1844-2021·Announced 2021-06-16

Quanta System Sterile Optical Laser Fiber Recall for Potential Sterility Compromise

Quanta System is recalling 307 reusable sterile optical laser fibers nationwide due to potential sterility compromise. The affected devices were distributed through six U.S. distributors.

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 an FDA Class II recall with no reported illnesses or injuries. The hazard is potential sterility compromise, representing a risk-of-harm scenario where injury has not yet been reported, consistent with the 'High' severity classification.

Plain-English summary

Quanta System, S.p.A. is recalling Quanta System Sterile Optical Laser Fiber, reusable devices. The recall affects 307 units distributed nationwide through six U.S. distributors. Specific part numbers and lot codes are listed in the FDA recall notice.

The recall is due to potential compromise of product sterility. In medical devices, compromised sterility can pose a risk to patients if the devices are used clinically.

Affected healthcare facilities and medical professionals are advised to consult the FDA recall notice for detailed information and any instructions from the manufacturer.

The recalled product

Product: Quanta System Sterile Optical Laser Fiber, reusable
Manufacturer: Quanta System, S.p.A.
Category: Medical Device — Optical Laser Equipment
Hazard: sterility-compromise
infection-risk
Affected units: 307

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 (10)

Product Part Numbers: OAF002013 Lots A201003 OAF005513 Lots A184636
A192118
A193101 OAF006003 Lot A195008 OAF008003 Lots A193615
A194021 OAF008013 Lots A183623
A192119 OAF009903 Lots A193109
A193617 OAF009913 Lots A181350
A192910 OAF702713 Lots A182415
A193104
A194109
A194723 OAF703613 Lot A180150

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Quanta System, S.p.A. 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 →

Same manufacturer · Quanta System, S.p.A.

See all →

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Same hazard · sterility compromise