Synergetics Recalls 25ga Awh Vivid Chandelier Due to Faulty Seals
Synergetics is recalling 108 units of 25ga Awh Vivid Chandeliers because faulty seals on the outer pouch could fail, potentially compromising the sterile status of the ophthalmic devices.
What this means for you
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 injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Synergetics Inc. is recalling 108 units of 25ga Awh Vivid Chandelier ophthalmic devices. The devices are 7.5 feet in length, sterile, ethylene oxide (EO) processed, and packed 12 units per box. The specific lot number is M261810.
The recall is being conducted because faulty seals on the outer pouch of these double-pouched, single-use devices could result in seal failure. This defect poses a risk to the sterile integrity of the ophthalmic instruments.
The affected units 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 Synergetics Inc. for further instructions.
The recalled product
- Product
- 25ga Awh Vivid Chandelier, Synergetics, length 7.5 ft, sterile / EO, 56.54.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
- Manufacturer
- Synergetics Inc
- Affected units
- 108
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: M261810
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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