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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Quanta System, S.p.A.: Product sterility is potentially compromised.

Agency Publication Date: June 10, 2021
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Affected Products

Product: Olympus Sterile Optical Laser Fiber, single use and reusable

Product Part Numbers: OFH302721 - lots H182604, H182605, H184521, H204109, H204110, H204111, H204112 OFH002711 - lots H182606, H182607, H182608, H182609, H182701, H182702, H182703, H182704, H182709, H204113, H204114, H204115, H204116, H204117, H204134 OFH302711 - lots H181600, H182011, H184001, H184002, H190309, H190310, H190311, H190312, H194031, H194032, H194033, H194034, H194035, H194111, H194112, H194113, H194114, H194115, H194116, H194117, H194118, H194119, H194120, H194121, H194122, H194123, H194124, H194319, H194320, H194321, H194322, H194323, H194324, H200831, H200832, H200833, H200834, H200835, H200836, H200837, H204120, H204121, H204122, H204201, H204826 OFH009911 - lots H181600, H184015, H184522, H184523, H191501, H191502, H191503, H191504, H191505, H191506, H191507, H191508, H191509, H202018, H202019, H202020, H202816, H202817, H202819, H202820, H204202, H204203, H204204 OFH005511 - lots H182012, H184012, H184013, H184014, H195016, H195017, H195018, H195019, H195020, H202813, H202814, H204509 OFH703611 - lots H181600, H182003, H182004, H182009, H183919, H183920, H183921, H183922, H183923, H183924, H184009, H184010, H184011, H184514, H184515, H184625, H184626, H184627, H184628, H194314, H194315, H194316, H194317, H194318, H194609, H194610, H194611, H194612, H194613, H194614, H194615, H202030, H202031, H202032, H202033, H202034, H202035, H202036, H202037, H202038, H202039, H202808, H202809, H202811, H202812, H204131, H204132, H204133 OFH702711 - lots H181600, H181601, H181602, H182001, H182002, H184006, H184007, H184008, H184629, H184630, H194102, H194103, H194104, H194105, H194106, H194201, H194202, H194203, H194204, H194205, H194325, H194616, H194617, H194618, H200411, H200412, H200916, H200917, H200918, H200919, H200920, H200921, H200922, H200923, H200924, H203803, H203804, H203805, H203806, H203807, H203809, H203810, H203811, H203812, H203813, H203814, H204123, H204124, H204125, H204126, H204127, H204128, H204129, H204130, H204901, H204902, H204903, H204904, H204905 OFH002011 - lots H181600, H182010, H184003, H184004, H184005, H184517, H184518, H184519, H184520, H190304, H190305, H190306, H190307, H190308, H194107, H194108, H194711, H194712, H194713, H194714, H194715, H194716, H194717, H194718, H194719, H194720, H200401, H200402, H200403, H200404, H200405, H200406, H200407, H200408, H200409, H200410, H200901, H200902, H200903, H200904, H200905, H200906, H200907, H200908, H200909 OFH002013 Lots H183616 and H183618 OFH002713 Lots H193012, H193014, H193015, H193016, H193017, H193018, H194101, H202823, H202824 OFH005513 Lot H181600 OFH702713 Lot H181600 OFH703613 Lots H183619, H183620, H183621, H183622, H204118, H204119

Lot Numbers:
H181600
H181600
Product: Quanta System Sterile Optical Laser Fiber, single use

Product Part Numbers: OAF002011 - lots A194207, A194208, A194528, A194529, A201001, A201002 OAF005511 - lots A184635, A192114, A193613, A194527, A202027 OAF006001 - lots A183626 and A193106 OAF008001 - lot A193616 OAF009901 - lot A192911 and A193108 OAF009911 - lots A192914 and A202028 OAF302711 - lot A202029 OAF402011 - lots A380350, A384633, A392907 OAF702711 - lots A190301, A192113, A192906, A193110, A193111, A193112, A194108, A194211, A194532 OAF703611 - lots A180300, A190302, A190303, A192115, A192908, A193102, A193113, A194209, A194210, A195013, A195014

Lot Numbers:
A193616
A192911
A202029
Product: Quanta System Sterile Optical Laser Fiber, reusable

Product Part Numbers: OAF002013 Lots A201003 OAF005513 Lots A184636, A192118, A193101 OAF006003 Lot A195008 OAF008003 Lots A193615, A194021 OAF008013 Lots A183623, A192119 OAF009903 Lots A193109, A193617 OAF009913 Lots A181350, A192910 OAF702713 Lots A182415, A193104, A194109, A194723 OAF703613 Lot A180150

Lot Numbers:
A195008
A180150

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87814
Status: Resolved
Manufacturer: Quanta System, S.p.A.
Manufactured In: Italy
Units Affected: 3 products (26925 units; 2427 units; 307)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.