FDA Recalls 59,828 Covidien Surgiwand II Suction and Irrigation Devices
The FDA is recalling 59,828 units of the Covidien Surgiwand II Suction and Irrigation Device due to a manufacturing defect that generates particulate matter inside the tubing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II, and the hazard involves particulate matter in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 59,828 units of the Covidien Surgiwand II Suction and Irrigation Device, including electrosurgical cutting and coagulation accessories. The affected product numbers are 178083, 178093, and 178094. The recall is classified as Class II by the FDA.
The recall was initiated after investigations into customer complaints identified particulate matter inside the device's tubing components. The root cause was determined to be a damaged Y-Connector component that connects the tubing to the device. This damage occurs during the assembly process when the tubing component is connected to the Y-Connector, resulting in the generation of the observed particulate matter.
The devices were distributed domestically across 33 U.S. states and internationally to numerous countries, including Canada, Japan, Australia, and various nations in Europe, Asia, and the Americas. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices, nor does it report any specific illnesses or injuries associated with the defect.
The recalled product
- Product
- Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094
- Manufacturer
- Covidien
- Affected units
- 59,828
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 (4)
- UDI-Device Identifier (GTIN/UPN): 10884523000887
- 20884523000884 UDI-Device Identifier (GTIN/UPN): 10884523000900
- 20884523000907 UDI-Device Identifier (GTIN/UPN): 10884523000917
- 20884523000914
Distribution
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