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.

Reason: Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.

Code information: Lot numbers: M257130 and M265370

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of 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.