CLASS II Device recall · Reported 24 Aug 2016 · FDA Enforcement Report
Mammography recalled by Avid Medical
Avid Medical is recalling Mammography, distributed in Massachusetts, Virginia. The recall was initiated on 5 Oct 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-2592-2016
- FDA event ID
- 73465
- Recalling firm
- Avid Medical, Toano, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Oct 2015
- FDA classified
- 18 Aug 2016
- Reported
- 24 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 5 Oct 2015 | Recall initiated by company | |
| 18 Aug 2016 | Classified by FDA | +318 days |
| 24 Aug 2016 | 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
Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex.
Product as listed by the FDA
MAMMOGRAPHY
Where it was distributed
Recalled product was distributed to 2 states: Virginia and Massachusetts.
Questions about this recall
Is Mammography recalled?
Yes. Avid Medical recalled Mammography on 5 Oct 2015. The recall is Class II and its status is Terminated. Recall number Z-2592-2016.
Why was it recalled?
Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex.
Which lots are affected?
Catalog No. LGHM022-02 , LOT# 1021706
Where was it sold?
Recalled product was distributed to 2 states: Virginia and Massachusetts.
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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