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

Lot, batch or date codesCatalog No. LGHM022-02 , LOT# 1021706
Quantity recalled200

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
E-Mail
Reason category
Other Reasons

Timeline

5 Oct 2015Recall initiated by company
18 Aug 2016Classified by FDA+318 days
24 Aug 2016Published 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.

MassachusettsVirginia

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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