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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87814

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 27, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Quanta System, S.p.A.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

Olympus Sterile Optical Laser Fiber, single use and reusable

Z-1842-2021
Recall number
Z-1842-2021
Initiated
April 27, 2021
Classification
Class II
Status
Terminated
Recalling firm
Quanta System, S.p.A.
Quantity
26925 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product sterility is potentially compromised.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility is potentially compromised.

Code information

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

Distribution pattern

Nationwide distribution via 6 US distributors

device · product 2 of 3

Quanta System Sterile Optical Laser Fiber, single use

Z-1843-2021
Recall number
Z-1843-2021
Initiated
April 27, 2021
Classification
Class II
Status
Terminated
Recalling firm
Quanta System, S.p.A.
Quantity
2427 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product sterility is potentially compromised.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility is potentially compromised.

Code information

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

Distribution pattern

Nationwide distribution via 6 US distributors

device · product 3 of 3

Quanta System Sterile Optical Laser Fiber, reusable

Z-1844-2021
Recall number
Z-1844-2021
Initiated
April 27, 2021
Classification
Class II
Status
Terminated
Recalling firm
Quanta System, S.p.A.
Quantity
307

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product sterility is potentially compromised.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility is potentially compromised.

Code information

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

Distribution pattern

Nationwide distribution via 6 US distributors