CLASS II Device recall · Reported 2 Feb 2022 · FDA Enforcement Report
FlexDex Needle Driver, Product recalled
FlexDex is recalling FlexDex Needle Driver, Product. The recall was initiated on 22 Dec 2021 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-0531-2022
- FDA event ID
- 89316
- Recalling firm
- FlexDex, Brighton, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Dec 2021
- FDA classified
- 27 Jan 2022
- Reported
- 2 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Syringes & Needles
Timeline
| 22 Dec 2021 | Recall initiated by company | |
| 27 Jan 2022 | Classified by FDA | +36 days |
| 2 Feb 2022 | 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
The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
8mm FlexDex Needle Driver, Product Code FD-335 ND
Where it was distributed
Not stated.
Questions about this recall
Is FlexDex Needle Driver, Product recalled?
Yes. FlexDex recalled FlexDex Needle Driver, Product on 22 Dec 2021. The recall is Class II and its status is Terminated. Recall number Z-0531-2022.
Why was it recalled?
The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used.
Which lots are affected?
All lots
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.
Other Syringes & Needles recalls
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|---|---|---|---|---|---|
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| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
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