Synergetics Recalls 25ga Wide Field Corona Endo Illuminator Due to Seal Failure
Synergetics Inc is recalling 96 units of 25ga Wide Field Corona 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 no injuries or illnesses have been reported in the source text.
Plain-English summary
Synergetics Inc is recalling 96 units of the 25ga Wide Field Corona Endo Illuminator. The affected devices are sterile, single-use, ophthalmic instruments with a length of 7.5 ft, packed 12 units per box. The specific lot numbers involved are M262080 and M270970.
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 medical device.
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. Healthcare facilities and users should stop using these specific lots and contact the recalling firm for instructions.
The recalled product
- Product
- 25ga 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
- 96
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 numbers: M262080 and M270970
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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