Synergetics Recalls 23ga Endo Illuminator Due to Faulty Seals
Synergetics Inc. is recalling 102 units of 23ga Endo Illuminator devices because faulty seals on the outer pouch could result in seal failure.
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 a seal failure could compromise sterility, but the source text does not report any injuries or illnesses.
Plain-English summary
Synergetics Inc. is recalling 102 units of the 23ga Endo Illuminator (Eckardt Trocar Compatible). The affected devices are sterile, single-use ophthalmic instruments with a length of 8.0 ft, packed 12 units per box. The recall involves lot numbers M257130 and M265370.
The recall was initiated because faulty seals on the outer pouch of these double-pouched devices could result in seal failure. This defect may compromise the sterile integrity of the medical devices.
The affected products 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. Users should stop using the affected devices and contact Synergetics Inc. for further instructions.
The recalled product
- Product
- 23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc., length 8.0 ft, sterile / EO, 56.02.23P Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
- Manufacturer
- Synergetics Inc
- Affected units
- 102
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: M257130 and M265370
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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