CLASS I Device recall · Reported 5 Oct 2016 · FDA Enforcement Report

Light Adaptor for Small Battery Drive and Small Battery Drive II recalled

The Anspach Effort is recalling Light Adaptor for Small Battery Drive and Small Battery Drive II, distributed nationwide in the US. The recall was initiated on 24 Jun 2016 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel/Catalog: Part # (05.001.108 and 05.001.024) Serial: All Serial Numbers.
Quantity recalled1,833 devices (05.001.024 and 05.001.108)

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-2783-2016
FDA event ID
74835
Recalling firm
The Anspach Effort, Palm Beach Gardens, FL
Classification
Class I
Status
Terminated
Recall initiated
24 Jun 2016
FDA classified
26 Sep 2016
Reported
5 Oct 2016
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Device Malfunction

Timeline

24 Jun 2016Recall initiated by company
26 Sep 2016Classified by FDA+94 days
5 Oct 2016Published in enforcement report+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Light Adaptor for Small Battery Drive and Small Battery Drive II.

Where it was distributed

Worldwide Distribution - US Nationwide and including the countries of Canada, Austria, Australia, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Libya, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, Slovakia, Spain, South Africa, South Korea, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam, and areas of Middle East, Africa, Asia & Pacific.

Nationwide

Questions about this recall

Is Light Adaptor for Small Battery Drive and Small Battery Drive II recalled?

Yes. The Anspach Effort recalled Light Adaptor for Small Battery Drive and Small Battery Drive II on 24 Jun 2016. The recall is Class I and its status is Terminated. Recall number Z-2783-2016.

Why was it recalled?

There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst.

Which lots are affected?

Model/Catalog: Part # (05.001.108 and 05.001.024) Serial: All Serial Numbers.

Where was it sold?

Worldwide Distribution - US Nationwide and including the countries of Canada, Austria, Australia, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Libya, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, Slovakia, Spain, South Africa, South Korea, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam, and areas of Middle East, Africa, Asia & Pacific.

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

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.

More recalls from The Anspach Effort

All 260

Other Other Medical Devices recalls

All 13,778