Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects
Cardinal Health is recalling sterile needle counters with blade disarmers because small holes in the packaging may compromise sterility.
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, and the hazard involves a potential compromise of sterility due to packaging defects. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Cardinal Health is recalling specific lots of sterile Needle Counters with Blade Disarmer. The recall involves three catalog numbers: 4FS30SSA, 4FS31SSA, and 4MM30SSA. These devices are used as a disposal system for counting used surgical blades and needles.
The recall was initiated because small holes, approximately 1 mm or less, were found in the device unit-level packaging. These defects potentially compromise the sterility of the product. The affected lots are distributed worldwide, including the United States, Australia, Canada, and Japan.
Healthcare facilities and consumers should stop using the affected products and contact Cardinal Health for instructions on return or replacement. The specific lot numbers affected are: for Catalog Number 4FS30SSA, all lot numbers less than or equal to 848031; for Catalog Number 4FS31SSA, lot number 739269; and for Catalog Number 4MM30SSA, all lot numbers less than or equal to 858154.
The recalled product
- Product
- Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FS30SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Dou
- Manufacturer
- Cardinal Health
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Cardinal Health 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.
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