Synergetics Recalls 23ga Wide Field Corona Endo Illuminator Due to Seal Failure
Synergetics Inc is recalling 108 units of 23ga Wide Field Corona Endo Illuminators because faulty seals on the outer pouch could result in seal failure.
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 injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Synergetics Inc is recalling 108 units of 23ga Wide Field Corona Endo Illuminators. The product is a sterile, single-use ophthalmic device manufactured for Synergetics, Inc., in O'Fallon, MO. The specific lot numbers involved are M264050, M269440, and M277900.
The recall was initiated 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 device.
The affected units were distributed worldwide, including nationwide in the United States and in 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. Healthcare providers and facilities should stop using these devices and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- 23ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. 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 (3)
- Lot numbers: M264050
- M269440
- and M277900
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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