CLASS II Device recall · Reported 9 Dec 2020 · FDA Enforcement Report
BD Ultra-Fine Pen Needles (5/32' )-intended recalled
Becton Dickinson & is recalling BD Ultra-Fine Pen Needles (5/32' )-intended for parenteral administration of a drug from, distributed nationwide in the US. The recall was initiated on 23 Oct 2020 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-0508-2021
- FDA event ID
- 86679
- Recalling firm
- Becton Dickinson &, Franklin Lakes, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Oct 2020
- FDA classified
- 27 Nov 2020
- Reported
- 9 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Syringes & Needles
Timeline
| 23 Oct 2020 | Recall initiated by company | |
| 27 Nov 2020 | Classified by FDA | +35 days |
| 9 Dec 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product shelf cartons incorrectly labeled as products intended for the Latin American market. Although the product description on the label 32G x 4mm pen needles is correct, information pertinent to users in the US regarding compatibility with specific pen needles is missing.
Product as listed by the FDA
BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a drug from a cartridge contained in a drug pen injector Catalog Number: 320122
Where it was distributed
Nationwide
Questions about this recall
Is BD Ultra-Fine Pen Needles (5/32' )-intended for parenteral administration of a drug from recalled?
Yes. Becton Dickinson & recalled BD Ultra-Fine Pen Needles (5/32' )-intended for parenteral administration of a drug from on 23 Oct 2020. The recall is Class II and its status is Terminated. Recall number Z-0508-2021.
Why was it recalled?
Product shelf cartons incorrectly labeled as products intended for the Latin American market. Although the product description on the label 32G x 4mm pen needles is correct, information pertinent to users in the US regarding compatibility with specific pen needles is missing.
Which lots are affected?
Batch Number: 9352052 Exp. Date: 20241231
Where was it sold?
Nationwide
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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