CLASS II Device recall · Reported 3 Jun 2020 · FDA Enforcement Report

Epix latis Grasper recalled by Applied Medical Resources

Applied Medical Resources is recalling Epix latis Grasper, distributed in 43 states. The recall was initiated on 17 Mar 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch: 1364578/Expiration Date: July 28, 2022; Batch: 1366453/Expiration Date: August 13, 2022; Batch: 1371249/Expiration Date: October 3, 2022; Batch: 1373050/Expiration Date: October 23, 2022; Batch: 1373248/Expiration Date: November 4, 2022; Batch: 1373249/Expiration Date: November 11, 2022; Batch: 1373255/Expiration Date: November 18, 2022; Batch: 1373260/Expiration Date: November 19, 2022; Batch; 1373261/Expiration Date: November 24, 2022; Batch: 1373262/Expiration Date: December 2, 2022; Batch: 1373263/Expiration Date: December 5, 2022; Batch: 1377363/Expiration Date: December 11, 2022; Batch: 1377364/Expiration Date: December 17, 2022

Quantity recalled32,760 units

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-2158-2020
FDA event ID: 85436
Recalling firm: Applied Medical Resources, Rancho Santa Margarita, CA
Classification: Class II
Status: Terminated
Recall initiated: 17 Mar 2020
FDA classified: 28 May 2020
Reported: 3 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

17 Mar 2020	Recall initiated by company
28 May 2020	Classified by FDA	+72 days
3 Jun 2020	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

There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147

Where it was distributed

US: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY OUS: Argentina, Australia, Austria, Belgium, Canada, Chile, Costa Rica, Denmark, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Latvia, Liechtenstein, Luxembourg, Netherlands, New Zealand, Peru, Portugal, Serbia, Singapore, South Africa, Spain, Thailand, United Kingdom

Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Hawaii Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi

Questions about this recall

Is Epix latis Grasper recalled?

Yes. Applied Medical Resources recalled Epix latis Grasper on 17 Mar 2020. The recall is Class II and its status is Terminated. Recall number Z-2158-2020.

Why was it recalled?

There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.

Which lots are affected?

Batch: 1364578/Expiration Date: July 28, 2022; Batch: 1366453/Expiration Date: August 13, 2022; Batch: 1371249/Expiration Date: October 3, 2022; Batch: 1373050/Expiration Date: October 23, 2022; Batch: 1373248/Expiration Date: November 4, 2022; Batch: 1373249/Expiration Date: November 11, 2022; Batch: 1373255/Expiration Date: November 18, 2022; Batch: 1373260/Expiration Date: November 19, 2022; Batch; 1373261/Expiration Date: November 24, 2022; Batch: 1373262/Expiration Date: December 2, 2022; Batch: 1373263/Expiration Date: December 5, 2022; Batch: 1377363/Expiration Date: December 11, 2022; Batch: 1377364/Expiration Date: December 17, 2022

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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