Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0985-2013·Announced 2013-04-03

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.

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, 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…
Manufacturer: Cardinal Health
Category: Medical Device — Surgical Disposal
Hazard: sterility-compromise
packaging-defect

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.

See all 9 products in this recall →

Same manufacturer · Cardinal Health

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Same hazard · sterility compromise