CLASS II Device recall · Reported 3 Apr 2013 · FDA Enforcement Report
Needle Counters;;/40 Capacity recalled by Cardinal Health
Cardinal Health is recalling Needle Counters;;/40 Capacity, distributed nationwide in the US. The recall was initiated on 18 Dec 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0978-2013
- FDA event ID
- 63951
- Recalling firm
- Cardinal Health, Mc Gaw Park, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Dec 2012
- FDA classified
- 28 Mar 2013
- Reported
- 3 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 18 Dec 2012 | Recall initiated by company | |
| 28 Mar 2013 | Classified by FDA | +100 days |
| 3 Apr 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
Questions about this recall
Is Needle Counters;;/40 Capacity recalled?
Yes. Cardinal Health recalled Needle Counters;;/40 Capacity on 18 Dec 2012. The recall is Class II and its status is Terminated. Recall number Z-0978-2013.
Why was it recalled?
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Which lots are affected?
Catalog Number: 3FA40SSA Lot Numbers: all lot numbers less than or equal to 928782 Catalog Number: 3FM40SSA Lot Numbers: all lot numbers less than or equal to 911379
Where was it sold?
Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |