510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-1680-2025Class I

Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting...

Bausch & Lomb Incorporated / initiated 2025-03-27 / Open, Classified / root cause: manufacturing process
FDA source (opens on fda.gov)

Bausch & Lomb Surgical, Inc. began a recall of Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN on . FDA classified it as Class I and gives the reason as "In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1680-2025
Classification
Class I
Status
Open, Classified
Initiated
Posted
Recalling firm
Bausch & Lomb Incorporated
Product
Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
Product code
MFK Lens, Multifocal Intraocular
Reason for recall
In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
On 3/27/2025, a news release was published informing customers that the firm will send out detailed instructions for what to do with any stock on hand. On 4/4/2025, the news release was updated and customers were also informed in a recall notice of the following: For Patients: Cataract surgery patients experiencing eye discomfort should contact their eyecare professional immediately. For Eyecare Professionals: Continue to closely monitor cataract surgery patients for at least 48 hours after surgery. Please instruct patients with new or worsening symptoms to contact your office immediately. Customers were asked to do the following: 1) Quarantine and do not use affected products. 2) Complete and return the acknowledgment form with returned devices or if there are no affected devices to return email the form to [email protected] 3) Provide this notice to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred (as appropriate). Please transfer this notice to other organizations on which this action has an impact (as appropriate). Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. 4) All reported cases of TASS to date have occurred within 12 - 48 hours after eye surgery. Rare cases of TASS could have delayed onset, so we request post-operative patient care protocols be followed to closely monitor patients who have received an intraocular lens impacted by this recall. Firm is investigating to identify the root cause of the issue. If you have any questions, or to make a report, contact our Customer Care team at (800) 338-2020, option 9 or 1. On 5/1/2025, revised recall notices were sent informing customers that the firm is reducing the recall scope.
Quantity in commerce
48,237
Distribution
Worldwide distribution. US Nationwide including PR and GU, and the countries of CAN, AUS, AUT, BEL, BGR, IC, HRV, CZE, FRA, DEU, GRC, HUN, ITA, NLD, POL, PRT, ROU, ESP, GBR, NZL, HKG.
Product codes and lots
Description/Lots/UDI-DI: enVista Envy IOL (ENU)/3Q24764, 3Q24935, 3Q25113, 3Q25833, 3Q26256, 3Q26257, 3Q26538, 3Q26601, 3Q26603, 3Q26604, 3Q26679, 3Q26680, 3Q27353, 3Q27447, 3Q27457, 3Q27905, 3Q27907, 3Q28001, 3Q28002, 3Q28124, 3Q28125, 3Q28801, 3Q28901, 3Q28903, 3Q28904, 3Q28905, 3Q28906, 3Q29020, 3Q29021, 3Q29205, 3Q29266, 3Q29301, 3Q29302, 3Q29304, 3Q29305, 3Q29306, 3Q29401, 3Q29403, 3Q29405, 3Q29406, 3Q29545, 3Q29547, 3Q29548, 3Q29636, 3Q29637, 3Q29835, 3Q29837, 3Q30210, 3Q30310, 3Q30311, 3Q33702, 3Q33822, 3Q33918, 3Q33921, 3Q33924, 3Q33925, 3Q33928, 3Q34031, 3Q34034, 3Q34205, 3Q35006, 3Q35733, 3Q35735, 3Q35736, 3Q35738, 3Q35813, 3R01610, 3R01611, 3R02532, 3R02534, 3R02536, 3R02537, 3R02540, 3R02542, 3R02551, 3R02553, 3R02608, 3R02749, 3R02750, 3R02846, 3R03533, 3R03534, 3R03536, 3R03804, 3R03805, 3R03806, 3R04414, 3R04533, 3R05051, 3R05411, 3Q24749, 3Q24750, 3Q24751, 3Q24756, 3Q24763, 3Q24765, 3Q24766, 3Q24837, 3Q24842, 3Q24934, 3Q25115, 3Q25116, 3Q25117, 3Q25118, 3Q25119, 3Q25421, 3Q25422, 3Q25423, 3Q25424, 3Q25506, 3Q25834, 3Q25922, 3Q25923, 3Q26525, 3Q26527, 3Q26539, 3Q26602, 3Q26605, 3Q27252, 3Q27321, 3Q27322, 3Q27323, 3Q27324, 3Q27354, 3Q27456, 3Q27458, 3Q27906, 3Q27908, 3Q28003, 3Q28004, 3Q28011, 3Q28012, 3Q28802, 3Q29017, 3Q29018, 3Q29022, 3Q29203, 3Q29204, 3Q29303, 3Q29402, 3Q29404, 3Q29546, 3Q29550, 3Q29635, 3Q30211, 3Q30213, 3Q32503, 3Q33816, 3Q33817, 3Q33818, 3Q33819, 3Q33820, 3Q33821, 3Q33823, 3Q33920, 3Q33922, 3Q33926, 3Q33927, 3Q33929, 3Q34032, 3Q34033, 3Q34201, 3Q34202, 3Q34203, 3Q34204, 3Q34901, 3Q34903, 3Q35028, 3Q35031, 3Q35734, 3Q35812, 3R01612, 3R02136, 3R02535, 3R02539, 3R02541, 3R02543, 3R02601, 3R02602, 3R02603, 3R02607, 3R02710, 3R02711, 3R02845, 3R02848, 3R03411, 3R03502, 3R03643, 3R04411, 3R04412, 3R04531, 3R05048, 3R05049, 3R05052, 3R05627/ 10757770636478, 10757770637017, 10757770637031, 10757770637055, 10757770637079, 10757770637543, 10757770637093, 10757770637109, 10757770637536, 10757770637116, 10757770637123, 10757770637130, 10757770637147, 10757770637154, 10757770637161, 10757770637178, 10757770637185, 10757770637192, 10757770637208, 10757770637215, 10757770637222, 10757770637239, 10757770637246, 10757770637253, 10757770636485, 10757770637550, 10757770637277, 10757770637284, 10757770637291, 10757770637307, 10757770637314, 10757770637321, 10757770637338, 10757770637345, 10757770637352, 10757770637369, 10757770637376, 10757770637383, 10757770637390, 10757770637406, 10757770637413, 10757770637420, 10757770637437, 10757770637444, 10757770637451, 10757770637468, 10757770637475, 10757770637482, 10757770637499, 10757770637505, 10757770637512, 10757770637529, 10757770636492; enVista Envy Toric IOL (ETNU)/3Q25926, 3Q25930, 3Q26240, 3Q26426, 3Q26431, 3Q26435, 3Q26436, 3Q26440, 3Q26441, 3Q26621, 3Q26726, 3Q26727, 3Q26731, 3Q26819, 3Q26820, 3Q26910, 3Q26928, 3Q27216, 3Q27217, 3Q27219, 3Q27221, 3Q27223, 3Q27249, 3Q27250, 3Q27251, 3Q27264, 3Q27327, 3Q27330, 3Q27505, 3Q27506, 3Q27518, 3Q27742, 3Q27912, 3Q28007, 3Q28008, 3Q28009, 3Q28010, 3Q28013, 3Q28134, 3Q28136, 3Q28721, 3Q28809, 3Q28818, 3Q28908, 3Q28909, 3Q28910, 3Q29208, 3Q29210, 3Q29212, 3Q29409, 3Q29517, 3Q29642, 3Q29922, 3Q29959, 3Q29961, 3Q30005, 3Q30136, 3Q30137, 3Q30138, 3Q30139, 3Q30208, 3Q30309, 3Q30453, 3Q30454, 3Q30517, 3Q30646, 3Q30647, 3Q30725, 3Q30741, 3Q30744, 3Q30803, 3Q31102, 3Q31107, 3Q31108, 3Q31509, 3Q31540, 3Q31541, 3Q31543, 3Q31865, 3Q31866, 3Q31929, 3Q32003, 3Q32004, 3Q32005, 3Q32009, 3Q32010, 3Q32206, 3Q32209, 3Q32211, 3Q32330, 3Q32331, 3Q32439, 3Q32443, 3Q32525, 3Q32529, 3Q32530, 3Q32606, 3Q32735, 3Q32737, 3Q32743, 3Q32842, 3Q32844, 3Q32846, 3Q32851, 3Q32931, 3Q32932, 3Q33014, 3Q33015, 3Q33128, 3Q33203, 3Q33505, 3Q33508, 3Q33545, 3Q33604, 3Q33613, 3Q33721, 3Q33902, 3Q34121, 3Q34256, 3Q34258, 3Q34315, 3Q35117, 3Q35335, 3Q35430, 3Q35431, 3Q35432, 3Q35433, 3Q35532, 3Q35557, 3Q35624, 3Q35625, 3Q35626, 3Q35628, 3Q35631, 3Q35704, 3Q35741, 3Q35758, 3Q35942, 3R00250, 3R01019, 3R01604, 3R01905, 3R02801, 3R03722, 3R03807, 3R04116, 3Q24946, 3Q25501, 3Q25605, 3Q25606, 3Q25703, 3Q25704, 3Q25722, 3Q25723, 3Q25725, 3Q25740, 3Q25741, 3Q25835, 3Q25836, 3Q25838, 3Q25839, 3Q25924, 3Q25925, 3Q25928, 3Q25931, 3Q25932, 3Q25933, 3Q26003, 3Q26004, 3Q26011, 3Q26012, 3Q26013, 3Q26059, 3Q26060, 3Q26061, 3Q26062, 3Q26063, 3Q26075, 3Q26076, 3Q26077, 3Q26078, 3Q26079, 3Q26080, 3Q26101, 3Q26102, 3Q26211, 3Q26212, 3Q26213, 3Q26214, 3Q26215, 3Q26216, 3Q26217, 3Q26230, 3Q26231, 3Q26232, 3Q26233, 3Q26234, 3Q26235, 3Q26236, 3Q26237, 3Q26238, 3Q26239, 3Q26241, 3Q26259, 3Q26260, 3Q26320, 3Q26321, 3Q26322, 3Q26323, 3Q26324, 3Q26325, 3Q26326, 3Q26327, 3Q26427, 3Q26428, 3Q26430, 3Q26432, 3Q26433, 3Q26434, 3Q26437, 3Q26439, 3Q26442, 3Q26443, 3Q26523, 3Q26524, 3Q26620, 3Q26623, 3Q26624, 3Q26625, 3Q26626, 3Q26721, 3Q26722, 3Q26723, 3Q26724, 3Q26725, 3Q26728, 3Q26729, 3Q26730, 3Q26732, 3Q26821, 3Q26822, 3Q26823, 3Q26824, 3Q26901, 3Q26902, 3Q26903, 3Q26904, 3Q26905, 3Q26908, 3Q26909, 3Q26930, 3Q27218, 3Q27220, 3Q27222, 3Q27224, 3Q27225, 3Q27248, 3Q27256, 3Q27265, 3Q27325, 3Q27326, 3Q27328, 3Q27329, 3Q27331, 3Q27332, 3Q27333, 3Q27334, 3Q27335, 3Q27350, 3Q27351, 3Q27352, 3Q27449, 3Q27501, 3Q27502, 3Q27503, 3Q27504, 3Q27516, 3Q27517, 3Q27519, 3Q27624, 3Q27625, 3Q27626, 3Q27627, 3Q27628, 3Q27629, 3Q27743, 3Q27744, 3Q27745, 3Q27909, 3Q27910, 3Q27911, 3Q27913, 3Q27914, 3Q28005, 3Q28006, 3Q28014, 3Q28127, 3Q28129, 3Q28130, 3Q28131, 3Q28132, 3Q28133, 3Q28135, 3Q28228, 3Q28719, 3Q28806, 3Q28807, 3Q28808, 3Q28810, 3Q28907, 3Q28911, 3Q29104, 3Q29105, 3Q29106, 3Q29128, 3Q29129, 3Q29130, 3Q29206, 3Q29207, 3Q29209, 3Q29211, 3Q29213, 3Q29214, 3Q29307, 3Q29308, 3Q29309, 3Q29310, 3Q29311, 3Q29312, 3Q29407, 3Q29408, 3Q29410, 3Q29411, 3Q29412, 3Q29451, 3Q29452, 3Q29515, 3Q29516, 3Q29518, 3Q29519, 3Q29520, 3Q29522, 3Q29523, 3Q29643, 3Q29644, 3Q29645, 3Q29705, 3Q29706, 3Q29707, 3Q29708, 3Q29709, 3Q29710, 3Q29711, 3Q29712, 3Q29713, 3Q29801, 3Q29838, 3Q29920, 3Q29921, 3Q29923, 3Q29957, 3Q29958, 3Q29960, 3Q30001, 3Q30002, 3Q30003, 3Q30004, 3Q30140, 3Q30201, 3Q30202, 3Q30203, 3Q30204, 3Q30205, 3Q30206, 3Q30207, 3Q30209, 3Q30301, 3Q30302, 3Q30303, 3Q30305, 3Q30306, 3Q30307, 3Q30308, 3Q30403, 3Q30434, 3Q30435, 3Q30437, 3Q30439, 3Q30440, 3Q30515, 3Q30516, 3Q30520, 3Q30523, 3Q30635, 3Q30636, 3Q30637, 3Q30648, 3Q30649, 3Q30740, 3Q30742, 3Q30743, 3Q30746, 3Q30747, 3Q30748, 3Q30749, 3Q30801, 3Q30812, 3Q30814, 3Q30815, 3Q30816, 3Q30817, 3Q30818, 3Q30902, 3Q30903, 3Q30904, 3Q30926, 3Q30927, 3Q30939, 3Q30940, 3Q30941, 3Q30942, 3Q31006, 3Q31007, 3Q31008, 3Q31042, 3Q31043, 3Q31053, 3Q31054, 3Q31101, 3Q31103, 3Q31104, 3Q31105, 3Q31106, 3Q31109, 3Q31110, 3Q31213, 3Q31214, 3Q31218, 3Q31219, 3Q31237, 3Q31238, 3Q31239, 3Q31450, 3Q31507, 3Q31508, 3Q31539, 3Q31542, 3Q31544, 3Q31601, 3Q31604, 3Q31605, 3Q31606, 3Q31607, 3Q31608, 3Q31609, 3Q31610, 3Q31611, 3Q31715, 3Q31716, 3Q31717, 3Q31718, 3Q31719, 3Q31720, 3Q31721, 3Q31842, 3Q31843, 3Q31844, 3Q31867, 3Q31868, 3Q31928, 3Q31930, 3Q31931, 3Q31932, 3Q31933, 3Q32001, 3Q32002, 3Q32006, 3Q32007, 3Q32008, 3Q32011, 3Q32012, 3Q32037, 3Q32128, 3Q32129, 3Q32130, 3Q32131, 3Q32155, 3Q32156, 3Q32157, 3Q32158, 3Q32159, 3Q32160, 3Q32201, 3Q32202, 3Q32203, 3Q32204, 3Q32205, 3Q32207, 3Q32208, 3Q32210, 3Q32212, 3Q32328, 3Q32329, 3Q32408, 3Q32409, 3Q32410, 3Q32411, 3Q32412, 3Q32440, 3Q32441, 3Q32442, 3Q32444, 3Q32506, 3Q32521, 3Q32522, 3Q32523, 3Q32524, 3Q32526, 3Q32527, 3Q32528, 3Q32607, 3Q32704, 3Q32738, 3Q32739, 3Q32740, 3Q32741, 3Q32742, 3Q32744, 3Q32745, 3Q32843, 3Q32845, 3Q32847, 3Q32848, 3Q32849, 3Q32850, 3Q32929, 3Q32930, 3Q32933, 3Q32934, 3Q32935, 3Q32936, 3Q32937, 3Q33004, 3Q33008, 3Q33009, 3Q33010, 3Q33011, 3Q33012, 3Q33013, 3Q33016, 3Q33017, 3Q33018, 3Q33019, 3Q33101, 3Q33102, 3Q33103, 3Q33129, 3Q33130, 3Q33131, 3Q33132, 3Q33133, 3Q33134, 3Q33204, 3Q33206, 3Q33207, 3Q33208, 3Q33503, 3Q33504, 3Q33506, 3Q33507, 3Q33543, 3Q33544, 3Q33546, 3Q33548, 3Q33605, 3Q33606, 3Q33607, 3Q33611, 3Q33614, 3Q33718, 3Q33719, 3Q33720, 3Q33722, 3Q33723, 3Q33731, 3Q33732, 3Q33824, 3Q33825, 3Q33826, 3Q33827, 3Q33828, 3Q33829, 3Q33901, 3Q34122, 3Q34123, 3Q34124, 3Q34125, 3Q34126, 3Q34127, 3Q34209, 3Q34210, 3Q34211, 3Q34257, 3Q34316, 3Q34317, 3Q34319, 3Q34320, 3Q34321, 3Q34323, 3Q34324, 3Q34325, 3Q34326, 3Q34327, 3Q34328, 3Q34329, 3Q34330, 3Q34331, 3Q34334, 3Q34335, 3Q34336, 3Q34431, 3Q34432, 3Q34436, 3Q34438, 3Q34440, 3Q34516, 3Q34518, 3Q34521, 3Q34522, 3Q34523, 3Q34524, 3Q34527, 3Q34528, 3Q34529, 3Q34530, 3Q34532, 3Q34536, 3Q34537, 3Q34538, 3Q34628, 3Q34633, 3Q34712, 3Q34713, 3Q34715, 3Q34716, 3Q34719, 3Q34720, 3Q34729, 3Q34732, 3Q34745, 3Q34828, 3Q34831, 3Q34832, 3Q34833, 3Q34835, 3Q34836, 3Q34837, 3Q34839, 3Q34840, 3Q34842, 3Q34843, 3Q34845, 3Q34913, 3Q34914, 3Q34916, 3Q34919, 3Q34921, 3Q35022, 3Q35118, 3Q35119, 3Q35120, 3Q35122, 3Q35123, 3Q35126, 3Q35127, 3Q35174, 3Q35213, 3Q35217, 3Q35220, 3Q35223, 3Q35225, 3Q35226, 3Q35336, 3Q35337, 3Q35340, 3Q35341, 3Q35342, 3Q35346, 3Q35348, 3Q35350, 3Q35408, 3Q35429, 3Q35527, 3Q35528, 3Q35529, 3Q35530, 3Q35531, 3Q35534, 3Q35535, 3Q35536, 3Q35559, 3Q35560, 3Q35627, 3Q35629, 3Q35630, 3Q35703, 3Q35739, 3Q35740, 3Q35750, 3Q35842, 3Q35936, 3Q35937, 3Q35938, 3Q35939, 3Q35941, 3R00247, 3R00248, 3R00254, 3R00324, 3R00510, 3R00601, 3R00603, 3R00618, 3R00713, 3R01020, 3R01111, 3R01201, 3R01416, 3R01519, 3R01602, 3R01605, 3R01722, 3R01724, 3R01903, 3R02301, 3R02304, 3R02309, 3R02310, 3R02401, 3R02402, 3R02409, 3R02411, 3R02421, 3R02422, 3R02424, 3R02441, 3R02442, 3R02443, 3R02444, 3R02446, 3R02447, 3R02448, 3R02450, 3R02544, 3R02548, 3R02728, 3R02802, 3R02821, 3R02824, 3R02826, 3R03034, 3R03036, 3R03037, 3R03038, 3R03039, 3R03040, 3R03105, 3R03106, 3R03134, 3R03135, 3R03137, 3R03139, 3R03140, 3R03141, 3R03233, 3R03234, 3R03301, 3R03302, 3R03505, 3R03506, 3R03507, 3R03720, 3R03721, 3R03723, 3R03808, 3R03812, 3R04115, 3R04342, 3R04746, 3R05032, 3R05141/ 10757770640000, 10757770640017, 10757770640024, 10757770640031, 10757770640048, 10757770640055, 10757770640574, 10757770640062, 10757770640079, 10757770640086, 10757770640093, 10757770640109, 10757770640116, 10757770640123, 10757770640130, 10757770640147, 10757770640154, 10757770640161, 10757770640178, 10757770640185, 10757770640192, 10757770640208, 10757770640215, 10757770640222, 10757770640239, 10757770640246, 10757770640253, 10757770640260, 10757770640277, 10757770640284, 10757770640291, 10757770640307, 10757770640314, 10757770640321, 10757770640338, 10757770640345, 10757770640352, 10757770640369, 10757770640376, 10757770640383, 10757770640390, 10757770640406, 10757770640413, 10757770640420, 10757770640437, 10757770640444, 10757770640451, 10757770640468, 10757770640475, 10757770640482, 10757770640499, 10757770640505, 10757770640512, 10757770640529, 10757770640536, 10757770640543, 10757770640550, 10757770640567, 10757770640581, 10757770640598, 10757770640604, 10757770640611, 10757770640628, 10757770640635, 10757770640642, 10757770640659, 10757770640666, 10757770640673, 10757770640680, 10757770640697, 10757770640703, 10757770640710, 10757770640727, 10757770640734, 10757770640741, 10757770640758, 10757770640765, 10757770640772, 10757770640789, 10757770640796, 10757770640802, 10757770640819, 10757770640826, 10757770640833, 10757770640840, 10757770640857, 10757770640864, 10757770640871, 10757770640888, 10757770640895, 10757770640901, 10757770640918, 10757770640925, 10757770640932, 10757770640949, 10757770640956, 10757770640963, 10757770640970, 10757770640987, 10757770640994, 10757770641007, 10757770641014, 10757770641021, 10757770641038, 10757770641045, 10757770641052, 10757770641069, 10757770641076, 10757770641083, 10757770641090, 10757770641106, 10757770641113, 10757770641120, 10757770641137, 10757770641144, 10757770641151, 10757770641168, 10757770641175, 10757770641182, 10757770641199, 10757770641205, 10757770641212, 10757770641229, 10757770641236, 10757770641243, 10757770641250, 10757770641267, 10757770641274, 10757770641281, 10757770641298, 10757770641304, 10757770641311, 10757770641328, 10757770641335, 10757770641342, 10757770641359, 10757770641366, 10757770641373, 10757770641380, 10757770641397, 10757770641403, 10757770641410, 10757770641427, 10757770641434, 10757770641441, 10757770641458, 10757770641465, 10757770641472, 10757770641496, 10757770641502, 10757770641519, 10757770641526, 10757770641533, 10757770641540, 10757770641557, 10757770641564, 10757770641571, 10757770641588, 10757770641595, 10757770641601, 10757770641618, 10757770641625, 10757770641632, 10757770641649, 10757770641656, 10757770641663, 10757770641670, 10757770641687, 10757770641694, 10757770641700, 10757770641717, 10757770636553, 10757770641724, 10757770641731, 10757770641748, 10757770641755, 10757770641762, 10757770641779, 10757770641786, 10757770641793, 10757770641809, 10757770641816, 10757770641823, 10757770641830, 10757770641847, 10757770641854, 10757770641861, 10757770641878, 10757770641885, 10757770641892, 10757770641908, 10757770641915, 10757770641922, 10757770641939, 10757770641946, 10757770641953, 10757770641977, 10757770641984, 10757770641991, 10757770636560, 10757770642004, 10757770642011, 10757770642028, 10757770642035, 10757770642042, 10757770642059, 10757770642066, 10757770642073, 10757770642080, 10757770642097, 10757770642103, 10757770642110, 10757770642134, 10757770642141, 10757770642158, 10757770642165, 10757770642172, 10757770642189, 10757770642196, 10757770642202, 10757770642219, 10757770642226, 10757770642233, 10757770642240, 10757770642257, 10757770642264, 10757770642271, 10757770636577, 10757770642851, 10757770642868, 10757770642875, 10757770642882, 10757770642899, 10757770642905, 10757770642912, 10757770642929, 10757770642936, 10757770642943, 10757770642950, 10757770642967, 10757770642974, 10757770642981, 10757770642998, 10757770643001, 10757770643018, 10757770643025, 10757770643032, 10757770643049, 10757770643056, 10757770643063, 10757770643070, 10757770643087, 10757770643094, 10757770643100, 10757770643117, 10757770643124, 10757770643131, 10757770643148, 10757770643155, 10757770643162, 10757770643179, 10757770643186, 10757770643193, 10757770643209, 10757770643216, 10757770643223, 10757770643230, 10757770643247, 10757770643254, 10757770643261, 10757770643278, 10757770643285, 10757770643292, 10757770643308, 10757770643315, 10757770643322, 10757770643339, 10757770643346, 10757770643353, 10757770643360, 10757770643377, 10757770643384, 10757770643391, 10757770643407, 10757770643414, 10757770643469, 10757770643421, 10757770643438, 10757770643445, 10757770643452, 10757770643476, 10757770643483, 10757770643490, 10757770643506, 10757770643513, 10757770643520, 10757770643537, 10757770643544, 10757770643551, 10757770643568, 10757770643575, 10757770643582, 10757770643599, 10757770643605, 10757770643612, 10757770643629, 10757770643636, 10757770643643, 10757770643650, 10757770643667, 10757770643674, 10757770643681, 10757770643698, 10757770643704, 10757770643711, 10757770643728, 10757770643735, 10757770643742, 10757770643759, 10757770643766, 10757770643773, 10757770643780, 10757770643797, 10757770643803, 10757770643810, 10757770643827, 10757770643834, 10757770643841, 10757770643858, 10757770643865, 10757770643872, 10757770643889, 10757770643896, 10757770643902, 10757770643919, 10757770643926, 10757770643933, 10757770643940, 10757770643957, 10757770643964, 10757770643971, 10757770643988, 10757770643995, 10757770644008, 10757770644015, 10757770644022, 10757770644039, 10757770644046, 10757770644053, 10757770644060, 10757770644077, 10757770644084, 10757770644091, 10757770644107, 10757770644114, 10757770644121, 10757770644138, 10757770644145, 10757770644152, 10757770644169, 10757770644176, 10757770644183, 10757770644190, 10757770644206, 10757770644213, 10757770644220, 10757770644237, 10757770644244, 10757770644251, 10757770644268, 10757770644275, 10757770644282, 10757770644299, 10757770644305, 10757770644312, 10757770644329, 10757770644336, 10757770644343, 10757770644350, 10757770644367, 10757770644374, 10757770644381, 10757770644398, 10757770644404, 10757770644411, 10757770644428, 10757770644435, 10757770644442, 10757770644459, 10757770644466, 10757770644473, 10757770644480, 10757770644497, 10757770644503, 10757770644510, 10757770644527, 10757770644534, 10757770644541, 10757770644558, 10757770644602, 10757770644619, 10757770644626, 10757770644633, 10757770644640, 10757770644657, 10757770644664, 10757770644671, 10757770644688, 10757770644695, 10757770644701, 10757770644718, 10757770644725, 10757770644732, 10757770644749, 10757770644756, 10757770644763, 10757770644770, 10757770644787, 10757770644794, 10757770644800, 10757770644817, 10757770644824, 10757770644831, 10757770644848, 10757770644855, 10757770644862, 10757770644879, 10757770644886, 10757770644893, 10757770644909, 10757770644916, 10757770644923, 10757770644930, 10757770644947, 10757770644954, 10757770644961, 10757770644978, 10757770644985, 10757770644992, 10757770645005, 10757770645012, 10757770645029, 10757770645036, 10757770645043, 10757770645050, 10757770645067, 10757770645074, 10757770645081, 10757770645098, 10757770645104, 10757770645111, 10757770645128, 10757770645135, 10757770645142, 10757770645159, 10757770645166, 10757770636584, 10757770645173, 10757770645180, 10757770645197, 10757770645203, 10757770645210, 10757770645227, 10757770645234, 10757770645241, 10757770645258, 10757770645265, 10757770645272, 10757770645289, 10757770645296, 10757770645302, 10757770645319, 10757770645326, 10757770645333, 10757770645340, 10757770645357, 10757770645364, 10757770645371, 10757770645388, 10757770645395, 10757770645401, 10757770645418, 10757770645425, 10757770645432, 10757770636591, 10757770645449, 10757770645456, 10757770645463, 10757770645470, 10757770645487, 10757770645494, 10757770645500, 10757770645517, 10757770645524, 10757770645531, 10757770645548, 10757770645555, 10757770645562, 10757770645579, 10757770645586, 10757770645593, 10757770645609, 10757770645616, 10757770645623, 10757770645630, 10757770645647, 10757770645654, 10757770645661, 10757770645678, 10757770645685, 10757770645692, 10757770645708, 10757770636607

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1680-2025
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1679-2025Class IOngoingVoluntary: Firm initiated
Z-1680-2025Class IOngoingVoluntary: Firm initiated