Stryker High Flow Tube Set Recalled for Leaking and Detachment
Stryker is recalling High Flow Tube Sets with Real-Time Pressure Sensing because they consistently leak and detach from the cassette.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect (leaking/detachment) that poses a risk of harm during use, but the source text does not report any specific injuries, illnesses, or fatalities, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Corporation is recalling 5,089 boxes of High Flow Tube Sets with Real-Time Pressure Sensing (RTP), REF 0620-040-680. These are disposable, sterile accessories used with the PNEUMO SURE High Flow Insufflator. The recall was initiated because the heated tube sets were consistently leaking and detaching from the cassette.
The affected products were distributed nationwide to medical facilities, including government and military distribution. Foreign distribution included Argentina, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Saudi Arabia, UAE, and Uruguay, as well as unspecified locations in EMEA and Latin America. The recall covers specific lot numbers listed in the agency documentation.
Healthcare facilities should stop using the affected tube sets and contact Stryker Corporation for instructions on return or replacement. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- 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.
- Manufacturer
- Stryker Corporation
- Hazard
- Affected units
- 5,089
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI - 07613327055641
- Lot numbers: 18G0273
- 18H0323
- 18H0354
- 56004327
- 56004391
- 56004434
- 56004478
- 56004526
- 56004592
- 56004665
- 56004667
- 56004706
- 56004708
- 56004784
- 56004832
- 56005325
- 56005376
- 56005378
- 56005380
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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