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Browse Device Recalls

42 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 42 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 42 FDA device recalls.

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DateProductReasonClassFirm
Sep 12, 2025 Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 0088633321... Due to complaints of increased resistance when advancing the dilator within the introducer sheath... Class II Argon Medical Devices, Inc
Jul 2, 2024 BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-0... Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier,... Class II Argon Medical Devices, Inc
Jun 14, 2024 L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x ... Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains in... Class II Argon Medical Devices, Inc
Jun 8, 2023 Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Fil... There is the potential that the vena Cava Filter may not perform as intended which may result in ... Class II Argon Medical Devices, Inc
Jan 24, 2022 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6" Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the sa... Class II Argon Medical Devices, Inc
Oct 4, 2021 SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE... Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments. Class II Argon Medical Devices, Inc
Jul 8, 2021 Scorpion Portal Vein Access Set - Product Usage: used to gain access to the h... As a result of design changes, sheaths have exhibited cracking/breaking at the tips. Class II Argon Medical Devices, Inc
Dec 10, 2020 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S,... Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separ... Class II Argon Medical Devices, Inc
Dec 10, 2020 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N,... Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separ... Class II Argon Medical Devices, Inc
Dec 10, 2020 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N,... Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separ... Class II Argon Medical Devices, Inc
Dec 10, 2020 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, ... Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separ... Class II Argon Medical Devices, Inc
Dec 10, 2020 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S,... Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separ... Class II Argon Medical Devices, Inc
Dec 10, 2020 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C,... Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separ... Class II Argon Medical Devices, Inc
Jun 19, 2020 ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. ... Sterile introducer sheath set manufactured under one lot with different expiration dates. Class II Argon Medical Devices, Inc
Apr 26, 2020 Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 65550... Tungsten coils of the guidewire included in the introducer kit were detaching. Class II Argon Medical Devices, Inc
Apr 8, 2020 Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 008863... Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of... Class II Argon Medical Devices, Inc
Apr 8, 2020 Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 0088633... Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of... Class II Argon Medical Devices, Inc
Apr 8, 2020 PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UD... Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of... Class II Argon Medical Devices, Inc
Dec 4, 2019 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 1141... The stiffness of the soft end of the guidewire caused tissue perforation. Class I Argon Medical Devices, Inc
Dec 4, 2019 0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114... The stiffness of the soft end of the guidewire caused tissue perforation. Class I Argon Medical Devices, Inc
Dec 2, 2019 BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial... Incorrect product labeling. Class II Argon Medical Devices, Inc
Oct 16, 2018 (1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, R... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 Argon Medical Devices Plugs, Male/Female Luer Lock Plug, REF 041295000A, 50/b... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx.... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, N... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm n... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-steri... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Conver... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Sto... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straig... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
May 11, 2017 Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G A... Argon Medical has received a complaint from one of their distributors of a potential packaging de... Class II Argon Medical Devices, Inc
Jan 18, 2017 BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for... The recalling firm received a complaint from one of their customers of a potential defect in the ... Class II Argon Medical Devices, Inc
Jan 18, 2017 T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEED... The recalling firm received a complaint from one of their customers of a potential defect in the ... Class II Argon Medical Devices, Inc
Jan 18, 2017 HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or... The recalling firm received a complaint from one of their customers of a potential defect in the ... Class II Argon Medical Devices, Inc
Sep 8, 2016 MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. ... The supplier initiated a recall because affected lots of the micro-introducer have an outer diame... Class II Argon Medical Devices, Inc
Feb 17, 2016 ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and... The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheat... Class II Argon Medical Devices, Inc
Jun 18, 2015 Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Ma... Potential defect in the forming of the primary package of the blister that may compromise the ste... Class II Argon Medical Devices, Inc
Jun 18, 2015 T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lo... Potential defect in the forming of the primary package of the blister that may compromise the ste... Class II Argon Medical Devices, Inc
Jun 5, 2014 UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 320... UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during at... Class II Argon Medical Devices, Inc
Jun 5, 2014 UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 3... UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during at... Class II Argon Medical Devices, Inc
Jun 5, 2014 UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524... UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during at... Class II Argon Medical Devices, Inc
May 4, 2012 Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek ba... Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may comprom... Class II Argon Medical Devices, Inc

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.