Synergetics Vivid Endo Illuminator Recalled for Faulty Sterile Seals
Synergetics Inc. is recalling Vivid Endo Illuminators because faulty seals on the outer pouch could fail, compromising the sterile status of the single-use ophthalmic devices.
What this means for you
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 source text describes a potential seal failure that could compromise sterility but does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Synergetics Inc. is recalling 48 units of the Vivid Endo Illuminator, 20ga, sterile/EO, lot number M274760. The devices are single-use, ophthalmic instruments packed 12 units per box. The recall was initiated because faulty seals on the outer pouch of the double-pouched packaging could result in seal failure.
The affected devices were distributed worldwide, including in the United States and numerous international markets such as 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. The source text does not specify specific dates of distribution or the exact number of units distributed in each region.
Consumers and healthcare facilities should stop using the affected devices and contact Synergetics Inc. for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., length 7.5 ft, sterile / EO, 56.20P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
- Manufacturer
- Synergetics Inc
- Affected units
- 48
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: M274760
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.
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