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, which typically indicates a reasonable probability of temporary or medically reversible health consequences. The hazard is a potential loss of sterility due to packaging defects, with no reported illnesses or injuries mentioned in the source text.
Plain-English summary
Cardinal Health is recalling specific lots of sterile Needle Counters with Blade Disarmer. The recall involves two catalog numbers: 4FA70SSA (Adhesive Area) and 4FM70SSA (Magnetic Area). The affected units are 12.2 x 10.5 x 3.5 cm, have a 40-count/70-capacity, and feature a removable numbered foam block. The total quantity recalled is 1,248 units of the adhesive version and 43,920 units of the magnetic version.
The recall was initiated because small holes, approximately 1 mm or less in size, were found in the device unit-level packaging. These defects potentially compromise the sterility of the product, which is intended for the disposal and counting of used surgical blades and needles.
The affected products were distributed worldwide, including the United States (nationwide), Australia, Canada, and Japan. For catalog number 4FA70SSA, the recall includes all lot numbers less than or equal to 931750. For catalog number 4FM70SSA, the recall includes all lot numbers less than or equal to 912173. Users should check their inventory for these specific catalog and lot numbers and stop using the affected devices.
The recalled product
- Product
- Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA70SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; M
- 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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