Pneumosure recallZ-1727-2019 · 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-1727-2019
- Status
- Terminated
- Initiated by the company
- Mar 7, 2019
- Recalling firm
- Stryker Corporation
- Quantity
- 5,089 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 Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Pneumosure 0620040680Stryker Corporation · INSUFFLATOR, LAPAROSCOPIC1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 82489).
- Z-1726-2019 · TerminatedStryker High Flow II Tube Set, REF 0620-040-660, 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.
How recalls are matched to devices · Editorial policy · Report an error on this page