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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