RegWardenFDA facility compliance records
Recall

Class II — Applied Medical Resources Corp

Recalling firmAPPLIED MEDICAL RESOURCES
Registered facilityView this company's 3 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonThere 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.
ProductDR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620
Quantity21 units
DistributionUS: 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, Port…
Initiated2020-03-17
Classified2020-05-28
Terminated2022-02-17
Recall numberZ-2160-2020
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Applied Medical Resources Corp (Z-2160-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85436/

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