Stryker PneumoSure Insufflators Recalled for Flow Rate Drop
Stryker Endoscopy is recalling PneumoSure insufflators because the flow rate drops to zero when connected to a house gas source, suspending insufflation.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a functional failure that suspends insufflation rather than a hazard causing injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Endoscopy is recalling PneumoSure XL High Flow Insufflators and PneumoSure High Flow Insufflators, specifically the high pressure units (HPU) with 40L and 45L capacities. The affected model numbers include 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 620-040-601, 620-040-602, 620-040-604, and 105-210-684. The recall covers 489 units distributed worldwide, including the United States, Puerto Rico, and numerous international locations.
The recall is due to a defect where, when operating in high flow mode (40L/min, 15 mmHg) and connected to a house gas inlet source, the flow rate drops to 0L/min within seconds of insufflating. This triggers a red 'Check Gas Supply' symbol on the display and immediately suspends insufflation. The affected HPUs have lot numbers ranging from 0005051337 to 000505052795, and the PneumoSure insufflators have serial numbers ranging from 1510CE0342 to 1601CE0581.
Healthcare facilities and users should stop using the affected devices and contact Stryker Endoscopy for instructions on returning or replacing the units.
The recalled product
- Product
- PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure units (HPU) (40L and 45L). Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 620-040-601, 620-040-602, 620-040-604, 105-210-684 The Pneumo Sure XL High F
- Manufacturer
- Stryker Endoscopy
- Hazard
- Affected units
- 489
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 (2)
- HPUs affected lot numbers 0005051337-000505052795
- PneumoSure insufflators affected serial numbers 1510CE0342-1601CE0581
Distribution
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