Class II — Cardinal Health
| Recalling firm | Cardinal Health 200, LLC |
|---|---|
| Registered facility | View this company's 35 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. |
| Product | Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA) Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 3FM40SSA) Product Usage: Disposal system for counting of used surgical blades and needles. |
| Quantity | Cat. No. 3FA40SSA: 23,952; Cat. No. 3FM40SSA: 140,736 |
| Distribution | Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan. |
| Initiated | 2012-12-18 |
| Classified | 2013-03-28 |
| Terminated | 2016-08-01 |
| Recall number | Z-0978-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cardinal Health (Z-0978-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63951/
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