CLASS II Device recall · Reported 13 Apr 2016 · FDA Enforcement Report

STD GK258, AME Standard Kit recalled by Applied Medical Resources

Applied Medical Resources is recalling STD GK258, AME Standard Kit 44, distributed nationwide in the US. The recall was initiated on 22 Dec 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 1238155, 1238402, 1238845

Quantity recalledN/A

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-1330-2016
FDA event ID: 73456
Recalling firm: Applied Medical Resources, Rancho Santa Margarita, CA
Classification: Class II
Status: Terminated
Recall initiated: 22 Dec 2015
FDA classified: 5 Apr 2016
Reported: 13 Apr 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

22 Dec 2015	Recall initiated by company
5 Apr 2016	Classified by FDA	+105 days
13 Apr 2016	Published in enforcement report	+8 days

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

Reason for recall

Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanism nonconformance.

Product as listed by the FDA

STD GK258, AME Standard Kit 44 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

Where it was distributed

U.S .Nationwide Distribution in the states of GA, AL, LA, TX, MN, AK, CA, ID, OR, UT, WY, NM, and AZ. Foreign distirbution to the following; Austria, Belgium, Denmarl, Canada, Japan, France, Germany, Ireland, Italy, Greece, Netherlands, Russia, Spain, Switzerland, Turkey, Great Britain

Nationwide Alaska Alabama Arizona California Georgia Idaho Louisiana Minnesota New Mexico Oregon Texas Utah Wyoming

Questions about this recall

Is STD GK258, AME Standard Kit 44 recalled?

Yes. Applied Medical Resources recalled STD GK258, AME Standard Kit 44 on 22 Dec 2015. The recall is Class II and its status is Terminated. Recall number Z-1330-2016.

Why was it recalled?

Which lots are affected?

Lot #: 1238155, 1238402, 1238845

Where was it sold?

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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