Synergetics Recalls 23ga Mid-Field Endo Illuminator Due to Seal Failure
Synergetics Inc is recalling 26 units of 23ga Mid-Field 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 device seal failure) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Synergetics Inc is recalling 26 units of the 23ga Mid-Field Endo Illuminator, Synergetics length 7.5 ft, sterile / EO, model 56.22.23P. The devices are packed 12 units per box and were manufactured for Synergetics, Inc., in O'Fallon, MO. The specific lot number is M270550.
The recall is due to faulty seals on the outer pouch of these double-pouched, single-use, sterile, ophthalmic devices. This defect could result in seal failure, which may compromise the sterile integrity of the device. The agency has classified this as a Class II recall.
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 the affected devices and contact Synergetics Inc for instructions on return or replacement.
The recalled product
- Product
- 23ga Mid-Field Endo Illuminator, Synergetics length 7.5 ft, sterile / EO, 56.22.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
- Manufacturer
- Synergetics Inc
- Affected units
- 26
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: M270550
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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