Rancho Santa Margarita, CA, United States
Applied Medical Resources Corp recalls
7 recalls recorded since 2018, most recently on 11 December 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)2
Terminated or completed5
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 11 December 2025
- Reason
- There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
- Distribution
- US: MI, CA, ME, OUS: France Great Britain, Germany
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1010-2026
- Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Ongoing Class II Medical devices
- Recall started
- 30 January 2024
- Reason
- Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Algeria, Argentina, A
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1388-2024, Z-1389-2024
- Epix Universal Clip Applier, REF: CA500, STERILEEO
- Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit 54562 GK1004, KIT LAP CHOL DEN HOED 2, GK1005, K2550 - H¿PATECTOMIE ERASME, GK1011, K-19459, GK
Terminated Class II Medical devices
- Recall started
- 17 March 2020
- Terminated
- 17 February 2022
- Reason
- 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.
- Distribution
- 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, In
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2160-2020, Z-2161-2020, Z-2158-2020, Z-2159-2020
- DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620
- Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)
- Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
- Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154
Terminated Class II Medical devices
- Recall started
- 31 January 2020
- Terminated
- 20 April 2022
- Reason
- Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KY, MA, MI, MO, NC, NE, NJ, NY, OK, PA, TN, TX, UT, VA. WA and WI. The countries of Austria, Australia, Canada, Switzerland, Germany, Spain, Finland, France, Italy, Japan, Mexic
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2036-2020, Z-2035-2020, Z-2034-2020, Z-2037-2020
- STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
- STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
- STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
- STEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile, REF/UDI::A1702/(01)10607915110649 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
Terminated Class I Medical devices
- Recall started
- 24 October 2019
- Terminated
- 1 June 2023
- Reason
- The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.
- Distribution
- Worldwide distribution - United States: Nationwide OUS: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Poland, Saudi Arabia, South Africa, Spain, Taiwan, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1846-2020, Z-1848-2020, Z-1847-2020
- Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01)00607915113445; A4E06/(01)006079151134
- Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)00607915111175
- Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DR/(01)H699CE0380DR10V; CE0440DR/(01)H699CE0440DR10S; CE0480DR/(01)H699CE0480DR10W; CE0540DR/(01)H699CE0540DR10T;
Terminated Class II Medical devices
- Recall started
- 28 January 2019
- Terminated
- 12 June 2020
- Reason
- The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents.
- Distribution
- Worldwide Distribution - US Nationwide Distribution: OUS: Japan, Australia, New Zealand, Spain, Italy, Great Britain, Germany, France, and Finland
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1959-2019
- Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp. Product Usage: Kii Fios first entry is indicated for use in general, abdominal
Terminated Class II Medical devices
- Recall started
- 12 December 2018
- Terminated
- 22 January 2021
- Reason
- Unintentional shifting of the tip insulation of the firm's electrosurgical probes.
- Distribution
- Worldwide distribution - US Nationwide distribution and countries of Belgium; Germany; Switzerland; Spain; Finland; France; Great Britain; Israel; India; Italy; Lebanon; Netherlands; and Portugal.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0510-2020, Z-0509-2020
- GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple in
- Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm REF CW002 QTY: 1 - Product Usage: The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy from an independe
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.