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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82489

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

Open FDA event record

Event summary

Timeline bucket
March 07, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Stryker Corporation

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

Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.

Z-1726-2019
Recall number
Z-1726-2019
Initiated
March 07, 2019
Classification
Class II
Status
Terminated
Recalling firm
Stryker Corporation
Quantity
32,537 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The heated tube sets were consistently leaking and detaching from the cassette.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The heated tube sets were consistently leaking and detaching from the cassette.

Code information

UDI - 07613327055634 Lot numbers: 18G0269, 18H0353, 18K0379 , 56004320, 56004325, 56004329, 56004356, 56004366, 56004373, 56004384, 56004387, 56004426, 56004432, 56004441, 56004443, 56004451, 56004459, 56004461, 56004487, 56004494, 56004502, 56004508, 56004515, 56004518, 56004528, 56004551, 56004565, 56004573, 56004584, 56004600, 56004614, 56004616, 56004624, 56004628, 56004632, 56004681, 56004686, 56004696, 56004704, 56004719, 56004721, 56004735, 56004737, 56004739, 56004748, 56004750, 56004760, 56004771, 56004791, 56004795, 56004809, 56004811, 56004816, 56004818, 56004820, 56004822, 56004826, 56004830, 56004842, 56004844, 56004846, 56004852, 56004881, 56004909, 56004913, 56004919, 56004925, 56004927, 56004929, 56004938, 56004950, 56004955, 56004957, 56004959, 56004970, 56004974, 56004976, 56004995, 56005003, 56005016, 56005018, 56005020, 56005097, 56005099, 56005104, 56005108, 56005128, 56005130, 56005132, 56005139, 56005198, 56005200, 56005206, 56005212, 56005229, 56005232, 56005246, 56005251, 56005267, 56005295, 56005297, 56005301, 56005323, 56005331, 56005339, 56005341, 56005343, 56005351, 56005353, 56005357, 56005360, 56005370, 56005372, 56005374, 56005426, 56005428, 56005440, 56005480, 56005484, 56005486, 56005504, 56005506, 56005508, 56005532, 56005534, 56005544, 56005555, 56005557, 56005588, 56005590, 56005599, 56005613, 56005615, 56005628, 56005631, 56005637, 56005640, 56005642, 56005671, 56005673, 56005686, 56005688, 56005694, 56005697, 56005710, 56005714, 56005717, 56005719, 56005728, 56005730, 56005732, 56005734, 56005749, 56005751, 56005753, 56005763, 56005765, 56005769, 56005772, 56005779, 56005812, 56005827, 56005833, 56005835, 56005837, 56005839, 56005850, 56005852, 56005858, 56005862, 56005874, 56005876, 56005895, 56005897, 56005913, 56005915, 56005933, 56005935, 56005950, 56005954, 56005965, 56005972, 56005974, 56005987, 56006156, 56006191, 56006201, 56006212, 56006216, 56006222, 56006224, 56006235, 56006249, 56006251, 56006268, 56006309, 56006311, 56006313, 56006321, 56006323, 56006325, 56006332, 56006334, 56006346, 56006348, 56006368, 56006372, 56006374, 56006378, 56006411, 56006413, 56006415, 56006430, 56006432, 56006454, 56006471, 56006473, 56006475, 56006491, 56006493, 56006495, 56006497, 56006501, 56006503, 56006506, 56006508, 56006510, 56006512, 56006542, 56006549, 56006554, 56006613, 56006633, 56006637, 56006540.

Distribution pattern

Distribution was nationwide to medical facilities. There was government/military distribution. Foreign distribution was made to Argentina, Brazil, Canada, Chile, Colombia, (EMEA-no specific address/country listed), India, Japan, Latin America (no country listed), Mexico, Saudi Arabia, UAE, and Uruguay.

device · product 2 of 3

Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.

Z-1727-2019
Recall number
Z-1727-2019
Initiated
March 07, 2019
Classification
Class II
Status
Terminated
Recalling firm
Stryker Corporation
Quantity
5,089 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The heated tube sets were consistently leaking and detaching from the cassette.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The heated tube sets were consistently leaking and detaching from the cassette.

Code information

UDI - 07613327055641; Lot numbers: 18G0273, 18H0323, 18H0354, 56004327, 56004391, 56004434, 56004478, 56004526, 56004592, 56004665, 56004667, 56004706, 56004708, 56004784, 56004832, 56005325, 56005376, 56005378, 56005380, 56005411, 56005450, 56005459, 56005538, 56005540, 56005633, 56005635, 56005744, 56005790, 56005899, 56005901, 56005989, 56005997, 56005999, 56006142, 56006154, 56006270, 56006340, 56006434, 56006521, 56006527, 56006556, 56006560, 56006606.

Distribution pattern

Distribution was nationwide to medical facilities. There was government/military distribution. Foreign distribution was made to Argentina, Brazil, Canada, Chile, Colombia, (EMEA-no specific address/country listed), India, Japan, Latin America (no country listed), Mexico, Saudi Arabia, UAE, and Uruguay.

device · product 3 of 3

Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.

Z-1728-2019
Recall number
Z-1728-2019
Initiated
March 07, 2019
Classification
Class II
Status
Terminated
Recalling firm
Stryker Corporation
Quantity
19,083 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The heated tube sets were consistently leaking and detaching from the cassette.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The heated tube sets were consistently leaking and detaching from the cassette.

Code information

UDI - 07613327055658; Lot numbers: 56004333, 56004335, 56004337, 56004342, 56004352, 56004375, 56004393, 56004419, 56004421, 56004423, 56004435, 56004445, 56004447, 56004465, 56004481, 56004485, 56004512, 56004520, 56004534, 56004541, 56004575, 56004577, 56004586, 56004597, 56004602, 56004626, 56004630, 56004643, 56004645, 56004649, 56004651, 56004710, 56004723, 56004725, 56004741, 56004752, 56004754, 56004757, 56004782, 56004786, 56004793, 56004836, 56004838, 56004840, 56004850, 56004863, 56004884, 56005075, 56005077, 56005081, 56005083, 56005085, 56005087, 56005089, 56005091, 56005093, 56005110, 56005112, 56005114, 56005116, 56005117, 56005124, 56005126, 56005141, 56005143, 56005145, 56005147, 56005149, 56005164, 56005168, 56005171, 56005173, 56005175, 56005177, 56005186, 56005190, 56005192, 56005194, 56005218, 56005223, 56005230, 56005236, 56005247, 56005253, 56005269, 56005275, 56005292, 56005292, 56005299, 56005310, 56005349, 56005355, 56005362, 56005364, 56005366, 56005368, 56005382, 56005384, 56005397, 56005409, 56005415, 56005417, 56005419, 56005431, 56005433, 56005435, 56005448, 56005463, 56005465, 56005500, 56005502, 56005511, 56005517, 56005519, 56005521, 56005525, 56005550, 56005552, 56005576, 56005578, 56005580, 56005582, 56005619, 56005644, 56005665, 56005680, 56005682, 56005726, 56005738, 56005759, 56005799, 56005808, 56005829, 56005854, 56005856, 56005887, 56005890, 56005909, 56005911, 56005919, 56005929, 56005937, 56005952, 56005970, 56005995, 56006006, 56006008, 56006014, 56006146, 56006148, 56006150, 56006163, 56006185, 56006187, 56006189, 56006210, 56006218, 56006220, 56006242, 56006255, 56006259, 56006261, 56006263, 56006282, 56006284, 56006286, 56006301, 56006303, 56006305, 56006307, 56006317, 56006342, 56006344, 56006376, 56006407, 56006424, 56006426, 56006442, 56006450, 56006463, 56006523, 56006525, 56006574, 56006576, 56006578, 56006601, 56006609, 56006620, 56006622, 56006631, 56006641, 56006643.

Distribution pattern

Distribution was nationwide to medical facilities. There was government/military distribution. Foreign distribution was made to Argentina, Brazil, Canada, Chile, Colombia, (EMEA-no specific address/country listed), India, Japan, Latin America (no country listed), Mexico, Saudi Arabia, UAE, and Uruguay.