Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2171-2015·Announced 2015-07-29

FDA Recalls Fiber Cleavers Due to Sterilization Validation Issues

American Medical Systems is recalling 16,710 Fiber Cleavers because cleaning and sterilization validation data do not meet FDA guidance for reusable medical devices.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a validation deficiency regarding sterilization methods rather than a reported injury or confirmed contamination, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

American Medical Systems Innovation Center - Silicon Valley is recalling 16,710 units of the 1X1 Cleaving Tiles (Fiber Cleaver), model 80-10007-001. These devices are reusable, sterilizable tools used to score the outer jacket on Endostat and SureFlex Fibers. The recall covers all products manufactured between April 8, 2012, and April 8, 2015.

The recall was initiated because validation data related to cleaning instructions and sterilization methods for these accessories do not meet the new FDA guidance on qualifying reusable products. The Fiber Cleaver is a one-piece, pencil-like design with a sharpened blade and does not come in direct contact with the patient.

The affected devices were distributed worldwide, including in the United States and numerous international markets. Users should stop using the recalled devices and contact American Medical Systems for instructions on return or replacement.

The recalled product

Product: 1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser…
Manufacturer: American Medical Systems Innovation Center - Silicon Valley
Category: Medical Device — Surgical Instrument
Hazard: sterilization-validation
Affected units: 16,710

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 (4)

Model 80-10007-001
All product manufactured from April 8
2012 to April 8
2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 32 recalled by American Medical Systems Innovation Center - Silicon Valley 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 32 products in this recall →

Same manufacturer · American Medical Systems Innovation Center - Silicon Valley

See all →

Moderate
FDA Recalls Disposable Fiber Strippers Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29
Moderate
FDA Recalls Fiber Cleaver Accessories Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29
High
FDA Recalls Disposable EndoStat Fiber Strippers Due to Validation Deficiencies
FDA (Devices) · 2015-07-29
Moderate
FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29
High
FDA Recalls Fiber Stripper Tools Due to Cleaning Validation Issues
FDA (Devices) · 2015-07-29

Same hazard · sterilization validation