Applied Medical Resources Corp

Complete recall history across all FDA and CPSC categories — 30 total recalls

Applied Medical Resources Corp appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (30)

FDA medical device enforcement actions by Applied Medical Resources Corp

Date Product Reason Class
Dec 11, 2025 Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23 There is the potential for extended length of the blade obturator after assem... Class II
Jan 30, 2024 Epix Universal Clip Applier, REF: CA500, STERILEEO included within the follow... Their is the potential that Universal Clip applier may not load clip after th... Class II
Jan 30, 2024 Epix Universal Clip Applier, REF: CA500, STERILEEO Their is the potential that Universal Clip applier may not load clip after th... Class II
Mar 17, 2020 Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY,... There may be a slightly protruding rivet on the distal end of the laparoscopi... Class II
Mar 17, 2020 Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY... There may be a slightly protruding rivet on the distal end of the laparoscopi... Class II
Mar 17, 2020 Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10) There may be a slightly protruding rivet on the distal end of the laparoscopi... Class II
Mar 17, 2020 DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620 There may be a slightly protruding rivet on the distal end of the laparoscopi... Class II
Jan 31, 2020 STEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile, REF/UDI::A1702/(01)10... Failure of cardiovascular clips to provide sufficient occlusion of the vessel. Class II
Jan 31, 2020 STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 ... Failure of cardiovascular clips to provide sufficient occlusion of the vessel. Class II
Jan 31, 2020 STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 ... Failure of cardiovascular clips to provide sufficient occlusion of the vessel. Class II
Jan 31, 2020 STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 ... Failure of cardiovascular clips to provide sufficient occlusion of the vessel. Class II
Oct 24, 2019 Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H69... The firm has received reports of tip separation during usage of the catheter... Class I
Oct 24, 2019 Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic... The firm has received reports of tip separation during usage of the catheter... Class I
Oct 24, 2019 Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)0060... The firm has received reports of tip separation during usage of the catheter... Class I
Jan 28, 2019 Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: ... The product may not have met sterility requirements . Use of a non-sterile d... Class II
Dec 12, 2018 Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 4... Unintentional shifting of the tip insulation of the firm's electrosurgical pr... Class II
Dec 12, 2018 GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with... Unintentional shifting of the tip insulation of the firm's electrosurgical pr... Class II
May 4, 2017 Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and K... Due to possibility of insufficient sterilization. Class II
Apr 1, 2016 Direct Drive Clip Applier CA090, indicated for ligation of tubular structures... Increased customer complaints indicating inconsistent clip application; may l... Class II
Dec 22, 2015 CA500 Epix Universal Clip Applier Product Usage: The Epix disposable lap... Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip ... Class II
Dec 22, 2015 STD GK258, AME Standard Kit 44 Product Usage: The Epix disposable laparo... Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip ... Class II
Dec 22, 2015 STD KIT GK213, AME Standard Kit 15 Product Usage: The Epix disposable la... Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip ... Class II
Dec 22, 2015 STD KIT GK260, Standard Set 360 Z Product Usage: The Epix disposable lap... Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip ... Class II
Jul 31, 2015 Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Ap... Potential to improperly characterize tissue within the jaws, which may result... Class II
Oct 21, 2013 Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue ... Applied Medical is conducting a voluntary recall of the Inzii¿ 12/15mm retrie... Class II
May 1, 2013 Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers... Applied Medical is conducting a voluntary recall on specific lot numbers of i... Class II
Nov 5, 2012 Laparoscope, general; plastic surgery Used for general, abdominal, gynecol... Applied Medical is conducting a voluntary recall on a specific lot number of ... Class II
Aug 9, 2012 Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Num... Applied Medical is recalling specific lot numbers of its Vascular Catheters b... Class II
Aug 9, 2012 Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IR... Applied Medical is recalling specific lot numbers of its Vascular Catheters b... Class II
Aug 9, 2012 Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: ... Applied Medical is recalling specific lot numbers of its Vascular Catheters b... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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