Synergetics Recalls 72 Sterile Ophthalmic Laser Probes Due to Seal Failure
Synergetics is recalling 72 sterile ophthalmic laser probes because faulty seals on the outer pouch could fail, potentially compromising sterility.
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 High severity criteria.
Plain-English summary
Synergetics, Inc. is recalling 72 units of 23ga Straight Fixed Extended Illuminated Laser Probes. The recall involves lot numbers M259970 and M267870. These devices are single-use, sterile, ophthalmic instruments manufactured in O'Fallon, Missouri, and distributed worldwide, including in the United States and 21 other countries.
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 devices may not remain sterile during use.
Healthcare providers and facilities that have received these specific lot numbers should stop using the affected probes and contact Synergetics, Inc. for instructions on return or replacement.
The recalled product
- Product
- 23ga Straight Fixed Extended Illuminated Laser Probe, Synergetics, length 7.5 ft, sterile / EO, 55.62.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
- Manufacturer
- Synergetics Inc
- Affected units
- 72
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: M259970 and M267870
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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