CLASS II Device recall · Reported 29 Jul 2015 · FDA Enforcement Report
Cochlear Nucleus Sterile Silicone Template recalled by Cochlear Americas
Cochlear Americas is recalling Cochlear Nucleus Sterile Silicone Template, distributed nationwide in the US. The recall was initiated on 5 Jun 2015 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-2155-2015
- FDA event ID
- 71509
- Recalling firm
- Cochlear Americas, Centennial, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jun 2015
- FDA classified
- 20 Jul 2015
- Reported
- 29 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hearing Aids
Timeline
| 5 Jun 2015 | Recall initiated by company | |
| 20 Jul 2015 | Classified by FDA | +45 days |
| 29 Jul 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
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
Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes
Where it was distributed
US Nationwide Distribution to CO, OH, OR, MI, and CA.
Questions about this recall
Why was it recalled?
Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
Which lots are affected?
Lot numbers: COH471122 Expiration 5/6/15 and Lot COH471123 Expiration 4/24/15
Where was it sold?
US Nationwide Distribution to CO, OH, OR, MI, and CA.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cochlear Americas
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Cochlear Baha 5 Sound Processor Tamper Proof Battery Door recalled | Cochlear Americas | Packaging Defects | 10 states |
| Device | CLASS II | Cochlear Baha Soft tissue gauge Reusable instrument used recalled | Cochlear Americas | Foreign Material | Nationwide |
Other Hearing Aids recalls
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits: Discectomy Pack DYNJ86476B Ear recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | See RES for full list recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | HiResolution" Bionic Ear System M Zn-Air Battery Pak recalled | Advanced Bionics | Device Malfunction | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Chp Cochlear Supplement Cds recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline medical procedure convenience kits labeled as recalled | Medline Industries | Device Malfunction | Nationwide |