Pneumosure recallZ-1726-2019 · Stryker Corporation · initiated Mar 7, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The heated tube sets were consistently leaking and detaching from the cassette.
FDA root cause category: Under Investigation by firm
What the company is doing
The recalling firm issued letters dated 3/7/2019 via certified mail on 3/7/2019. A second letter dated 3/7/2019 was issued on 4/15/2019 via certified mail to two customers which included an additional lot number for one of the products.
Recall details
- Recall number
- Z-1726-2019
- Status
- Terminated
- Initiated by the company
- Mar 7, 2019
- Recalling firm
- Stryker Corporation
- Quantity
- 32,537 boxes
- Product code
- HIF
- FDA submissions
- K063367
- Distribution
- 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.
Product description
Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Pneumosure 0620040660Stryker Corporation · INSUFFLATOR, LAPAROSCOPIC1 recall18 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 82489).
- Z-1727-2019 · TerminatedStryker 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-1728-2019 · TerminatedStryker 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.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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