CLASS II Device recall · Reported 21 Jun 2017 · FDA Enforcement Report
Stamey Needle recalled by Cook
Cook is recalling Stamey Needle, distributed nationwide in the US. The recall was initiated on 25 Apr 2017 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-2536-2017
- FDA event ID
- 77217
- Recalling firm
- Cook, Bloomington, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Apr 2017
- FDA classified
- 14 Jun 2017
- Reported
- 21 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Syringes & Needles
Timeline
| 25 Apr 2017 | Recall initiated by company | |
| 14 Jun 2017 | Classified by FDA | +50 days |
| 21 Jun 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
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
Stamey Needle
Where it was distributed
The devices have been distributed nationwide within the United States and the following countries: Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.
Questions about this recall
Is Stamey Needle recalled?
Yes. Cook recalled Stamey Needle on 25 Apr 2017. The recall is Class II and its status is Terminated. Recall number Z-2536-2017.
Why was it recalled?
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
Which lots are affected?
All lots Catalog numbers: 095000; 095015; 095030; J-SYN-931600; J-SYN-931615; J-SYN-931630
Where was it sold?
The devices have been distributed nationwide within the United States and the following countries: Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.
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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| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | Bd Switzerland Sarl | Other | IL |