Stryker FlowPort II Adapter Recalled Due to Incorrect Orientation
Stryker is recalling 21 FlowPort II Adapters because the arthroscope sits in the adapter 180 degrees in the wrong direction.
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 2/5 (Moderate).
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, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving a functional defect without reported harm.
Plain-English summary
Stryker Corporation is recalling 21 units of the FlowPort II Adapter, model number 00CAT00778, lot number 13604. This medical device is intended to connect FlowPort II Cannulas to commercially available 4mm arthroscopes during surgical procedures.
The recall was initiated after complaints were received and an investigation determined that the scope sits in the adapter 180 degrees in the wrong direction. The affected units were distributed in Georgia, Utah, Maryland, New Jersey, and Montana.
Healthcare providers and patients should stop using the affected adapters and contact Stryker Corporation for further instructions on the recall.
The recalled product
- Product
- Stryker FlowPort II Adapter: Model number: 00CAT00778 The FlowPort II Adapter is intended to connect the FlowPort II Cannulas to commercially available, 4mm arthroscopes in surgical procedures.
- Manufacturer
- Stryker Corporation
- Hazard
- Affected units
- 21
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 (1)
- Lot Numbers Affected: 13604
Distribution
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