Synergetics Recalls 27ga Endo Illuminator Due to Faulty Sterile Seals
Synergetics Inc. is recalling 96 units of 27ga ONE-STEP Endo Illuminator devices 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 a seal failure could lead to infection, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Synergetics Inc. is recalling 96 units of the 27ga ONE-STEP (tm) Endo Illuminator, a sterile, single-use ophthalmic device. The product is manufactured in O'Fallon, Missouri, and is packed 12 units per box. The specific lot number for this recall is M262090.
The recall was initiated because faulty seals on the outer pouch of the double-pouched devices could result in seal failure. This defect poses a risk that the sterile barrier may be compromised, potentially exposing the device to contamination before use.
The affected devices were distributed worldwide, including nationwide in the United States and in 21 other countries 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. Users should stop using the affected lot and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.27P. 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 number: M262090
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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