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Browse Device Recalls

30 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 30 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 30 FDA device recalls.

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DateProductReasonClassFirm
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 assembly into the cannula... Class II Applied Medical Resources Corp
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 the trigger is actuated. Class II Applied Medical Resources Corp
Jan 30, 2024 Epix Universal Clip Applier, REF: CA500, STERILEEO Their is the potential that Universal Clip applier may not load clip after the trigger is actuated. Class II Applied Medical Resources Corp
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 laparoscopic grasper which has ... Class II Applied Medical Resources Corp
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 laparoscopic grasper which has ... Class II Applied Medical Resources Corp
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 laparoscopic grasper which has ... Class II Applied Medical Resources Corp
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 laparoscopic grasper which has ... Class II Applied Medical Resources Corp
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 Applied Medical Resources Corp
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 Applied Medical Resources Corp
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 Applied Medical Resources Corp
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 Applied Medical Resources Corp
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 catheters, which may expose ... Class I Applied Medical Resources Corp
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 catheters, which may expose ... Class I Applied Medical Resources Corp
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 catheters, which may expose ... Class I Applied Medical Resources Corp
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 device on a patient m... Class II Applied Medical Resources Corp
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 probes. Class II Applied Medical Resources Corp
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 probes. Class II Applied Medical Resources Corp
May 4, 2017 Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and K... Due to possibility of insufficient sterilization. Class II Applied Medical Resources Corp
Apr 1, 2016 Direct Drive Clip Applier CA090, indicated for ligation of tubular structures... Increased customer complaints indicating inconsistent clip application; may lead to unoccluded ve... Class II Applied Medical Resources Corp
Dec 22, 2015 CA500 Epix Universal Clip Applier Product Usage: The Epix disposable lap... Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models ... Class II Applied Medical Resources Corp
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 Applier, kit models ... Class II Applied Medical Resources Corp
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 Applier, kit models ... Class II Applied Medical Resources Corp
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 Applier, kit models ... Class II Applied Medical Resources Corp
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 in nonoptimal power... Class II Applied Medical Resources Corp
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 retrieval system. During s... Class II Applied Medical Resources Corp
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 its Epix¿ and Direct ... Class II Applied Medical Resources Corp
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 its 12x150mm Kii shi... Class II Applied Medical Resources Corp
Aug 9, 2012 Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Num... Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have... Class II Applied Medical Resources Corp
Aug 9, 2012 Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IR... Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have... Class II Applied Medical Resources Corp
Aug 9, 2012 Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: ... Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have... Class II Applied Medical Resources Corp

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.