Needle Counters — Class II medical device recall Z-0978-2013
Terminated recall by Cardinal Health, reported 2013-04-03, distributed nationwide. Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product
| Recall number | Z-0978-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health, Mc Gaw Park, IL, United States |
| Recall initiated | 2012-12-18 |
| Classified | 2013-03-28 |
| Reported by FDA | 2013-04-03 |
| Terminated | 2016-08-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, JP |
| Reason classes | sterility |
| Model numbers | 3FA40SSA, 3FM40SSA |
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.
Reason for recall
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0978-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.