Agency classClass IIOur severity:High FDA (Devices)·Z-0895-2014·Announced 2014-02-05

Synergetics Recalls Stiff 25ga Wide Field Endo Illuminator Due to Seal Failure

Synergetics Inc is recalling specific lots of Stiff 25ga Wide Field Endo Illuminators because faulty seals on the outer pouch could fail, compromising sterility.

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: The recall involves a risk-of-harm product (sterile medical device) where seal failure could compromise sterility, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.

Plain-English summary

Synergetics Inc is recalling 507 units of Stiff 25ga Wide Field Endo Illuminators. The affected devices are sterile, single-use, ophthalmic instruments manufactured in O'Fallon, Missouri, and distributed worldwide, including in the United States and 22 other countries. The recall involves specific lot numbers: M260800, M262050, M263140, M264420, and M267440.

The recall is being conducted because faulty seals on the outer pouch of these double-pouched devices could result in seal failure. This defect poses a risk to the sterility of the instruments, which are intended for use in ophthalmic procedures.

Healthcare facilities and distributors should stop using the affected devices and contact Synergetics Inc for further instructions on the recall process.

The recalled product

Product: Stiff 25ga Wide Field Endo Illuminator, Synergetics, inc. length 7.5 ft, sterile / EO, 56.21.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Manufacturer: Synergetics Inc
Category: Medical Device — Ophthalmic Instruments
Hazard: seal-failure
sterility-compromise
Affected units: 507

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 (5)

Lot numbers: M260800
M262050
M263140
M264420
and M267440

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 28 recalled by Synergetics Inc 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 28 products in this recall →

Same manufacturer · Synergetics Inc

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