Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87764

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 19, 2021
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Vero Biotech, LLC

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

1 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 1

GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860

Z-1863-2021
Recall number
Z-1863-2021
Initiated
May 19, 2021
Classification
Class I
Status
Terminated
Recalling firm
Vero Biotech, LLC
Quantity
465 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.

Code information

Model #: 601588-01; Serial #'s: G0803, G0807, G0808, G0814, G0149, G0157, G0183, G0191, G0195, G0198, G0202, G0560, G0600, G0693, G0729, G0734, G0772, G0775, G0138, G0147, G0155, G0159, G0172, G0185, G0203, G0209, G0282, G0344, G0385, G0398, G0408, G0415, G0569, G0601, G0756, G0323, G0358, G0379, G0383, G0386, G0405, G0334, G0399, G0413, G0463, G0158, G0174, G0285, G0305, G0466, G0719, G0135, G0194, G0205, G0281, G0362, G0407, G0573, G0574, G0578, G0579, G0582, G0583, G0587, G0590, G0591, G0594, G0596, G0597, G0598, G0603, G0609, G0611, G0680, G0708, G0110, G0111, G0131, G0137, G0140, G0176, G0207, G0212, G0232, G0237, G0246, G0251, G0253, G0262, G0263, G0266, G0280, G0449, G0453, G0608, G0642, G0644, G0663, G0688, G0712, G0717, G0739, G0745, G0747, G0762, G0764, G0765, G0793, G0125, G0129, G0133, G0169, G0181, G0257, G0292, G0645, G0804, G0180, G0293, G0311, G0322, G0338, G0341, G0342, G0353, G0480, G0499, G0506, G0519, G0521, G0522, G0565, G0681, G0735, G0738, G0748, G0754, G0760, G0770, G0773, G0773, G0782, G0223, G0227, G0235, G0236, G0347, G0352, G0355, G0359, G0378, G0382, G0175, G0273, G0476, G0562, G0792, G0162, G0163, G0189, G0607, G0143, G0160, G0164, G0214, G0215, G0283, G0284, G0296, G0298, G0303, G0313, G0315, G0319, G0329, G0333, G0335, G0370, G0375, G0495, G0509, G0510, G0511, G0550, G0571, G0588, G0589, G0593, G0646, G0672, G0689, G0723, G0724, G0725, G0736, G0744, G0771, G0778, G0795, G0204, G0218, G0269, G0272, G0343, G0580, G0193, G0294, G0300, G0302, G0308, G0465, G0518, G0567, G0190, G0278, G0279, g0286, G0297, G0374, G0393, G0728, G0307, G0309, G0312, G0318, G0320, G0406, G0434, G0643, G0229, G0230, G0231, G0240, G0460, G0469, G0488, G0489, G0493, G0496, G0500, G0501, G0599, G0605, G0610, G0647, G0648, G0650, G0651, G0653, G0654, G0655, G0656, G0658, G0661, G0667, G0668, G0670, G0671, G0677, G0678, G0686, G0691, G0694, G0697, G0702, G0707, G0713, G0715, G0716, G0718, G0726, G0730, G0733, G0741, G0755, G0806, G0813, G0818, G0261, G0270, G0274, G0275, G0094, G0363, G0369, G0430, G0435, G0440, G0444, G0452, G0475, G0487, G0490, G0508, G0537, G0549, G0234, G0380, G0389, G0402, G0409, G0483, G0497, G0576, G0584, G0585, G0277, G0346, G0390, G0423, G0443, G0445, G0447, G0451, G0454, G0455, G0457, G0458, G0459, G0461, G0464, G0467, G0474, G0479, G0481, G0486, G0492, G0504, G0512, G0515, G0516, G0517, G0520, G0524, G0527, G0528, G0529, G0531, G0532, G0533, G0536, G0539, G0542, G0545, G0546, G0547, G0551, G0552, G0553, G0554, G0557, G0558, G0559, G0561, G0570, G0581, G0602, G0710, G0743, G0749, G0752, G0768, G0787, G0289, G0371, G0357, G0372, G0391, G0701, G0186, G0327, G0337, G0568, G0604, G0675, G0679, G0682, G0692, G0700, G0703, G0396, G0397, G0228, G0245, G0288, G0387, G0414, G0418, G0420, G0437, G0439, G0535, G0572, G0211, G0268, G0365, G0544, G0592, G0252, G0349, G0606, G0192, G0417, G0485, G0507, G0523, G0563, G0146, G0166, G0304, G0306, G0314, G0332, G0339, G0403, G0422, G0424, G0428, G0429, G0431, G0432, G0436, G0450, G0473, G0491, G0426, G0427, G0301, G0425, G0706, G0720, G0722, G0727, G0789, G0797, G0799, G0805, G0665, G0684, G0696, G0714, G0740, G0796, G0367, G0595, G0721, G0731, G0732, G0109, G0124, G0136, G0139, G0331, G0468, G0566, G0810, G0816, G0381, G0767, G0779, G0790, G0737, G0763, G0766, G0774

Distribution pattern

Distributed nationwide to TX, MD, VA, GA, FL, KS, LA, MN, and NC