Agency classClass IIOur severity:High FDA (Devices)·Z-0897-2014·Announced 2014-02-05

Synergetics 25ga Mid-Field Endo Illuminator Recalled for Seal Failure

Synergetics Inc is recalling 25ga Mid-Field Endo Illuminators because faulty seals on the outer pouch could fail, potentially 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 injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Synergetics Inc is recalling 25ga Mid-Field Endo Illuminators, a sterile, single-use ophthalmic device. The recall involves 6 units of the product, which is packed 12 units per box and manufactured for Synergetics, Inc. in O'Fallon, MO. The specific lot number is M276380.

The recall was initiated because faulty seals on the outer pouch of these double-pouched, single-use, sterile devices could result in seal failure. This defect poses a risk to the sterility of the medical device.

The affected products were distributed nationwide in the United States and internationally to Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom. Users should stop using the affected devices and contact the manufacturer for further instructions.

The recalled product

Product: 25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Manufacturer: Synergetics Inc
Category: Medical Device — Ophthalmic
Hazard: seal-failure
sterility-compromise
Affected units: 6

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: M276380

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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