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Browse Device Recalls

150 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 150 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 150 FDA device recalls.

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DateProductReasonClassFirm
Nov 29, 2016 Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: To evac... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with i... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean In... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single drain w... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pedi... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean dual ch... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 Atrium Medical 400 Series Express Drains as follows: 4000-100N Express sing... Outer Packaging is not sterile Class II Atrium Medical Corporation
Oct 26, 2016 Atrium Medical 24 Fr Trocar catheter, Sterile Model Number: 8424 Intende... Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha... Class II Atrium Medical Corporation
Oct 26, 2016 Atrium Medical 12 Fr Trocar catheter, Sterile Model Number: 8412 Intended... Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha... Class II Atrium Medical Corporation
Oct 26, 2016 Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Inten... Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha... Class II Atrium Medical Corporation
Oct 26, 2016 Atrium Medical 10 Fr Trocar catheter, Sterile Model Number: 8410 Intended... Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha... Class II Atrium Medical Corporation
Oct 26, 2016 Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended... Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha... Class II Atrium Medical Corporation
Oct 26, 2016 Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intende... Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha... Class II Atrium Medical Corporation
Oct 26, 2016 Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intend... Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha... Class II Atrium Medical Corporation
Oct 26, 2016 Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facil... Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha... Class II Atrium Medical Corporation
Jun 19, 2015 Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number... Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, b... Class II Atrium Medical Corporation
May 7, 2015 Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100 Chest drains have a missing o-ring Class II Atrium Medical Corporation
May 7, 2015 Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100 Chest drains have a missing o-ring Class II Atrium Medical Corporation
May 7, 2015 EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N Chest drains have a missing o-ring Class II Atrium Medical Corporation
May 7, 2015 Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000 Chest drains have a missing o-ring Class II Atrium Medical Corporation
Apr 28, 2014 Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-... Product that was previously recalled because the Chest Drain tubing of the ATS Blood recovery may... Class II Atrium Medical Corporation
Nov 19, 2013 Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock ... Chest Drain tubing of of the ATS Blood recovery may leak or disconnect Class II Atrium Medical Corporation
Nov 19, 2013 Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Dr... Chest Drain tubing of of the ATS Blood recovery may leak or disconnect Class II Atrium Medical Corporation
Nov 19, 2013 Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery Syst... Chest Drain tubing of of the ATS Blood recovery may leak or disconnect Class II Atrium Medical Corporation
Nov 19, 2013 Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery Syst... Chest Drain tubing of of the ATS Blood recovery may leak or disconnect Class II Atrium Medical Corporation
Nov 19, 2013 Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Dra... Chest Drain tubing of of the ATS Blood recovery may leak or disconnect Class II Atrium Medical Corporation
Nov 19, 2013 Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery Syst... Chest Drain tubing of of the ATS Blood recovery may leak or disconnect Class II Atrium Medical Corporation
Nov 19, 2013 Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery Sys... Chest Drain tubing of of the ATS Blood recovery may leak or disconnect Class II Atrium Medical Corporation
Nov 19, 2013 Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery Syst... Chest Drain tubing of of the ATS Blood recovery may leak or disconnect Class II Atrium Medical Corporation
Nov 19, 2013 Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery Syst... Chest Drain tubing of of the ATS Blood recovery may leak or disconnect Class II Atrium Medical Corporation
Jul 19, 2013 C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tiss... Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner pac... Class II Atrium Medical Corporation
Jul 19, 2013 C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficienc... Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner pac... Class II Atrium Medical Corporation
Jul 19, 2013 C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue... Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner pac... Class II Atrium Medical Corporation
Jul 19, 2013 C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue de... Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner pac... Class II Atrium Medical Corporation
Jul 16, 2013 PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200... Individual component's IFUs are not included with the kit. Class II Atrium Medical Corporation
Jul 12, 2013 Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular r... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta SST Grafts >or= 6mm Intended for use in arterial vascular reconstruc... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction,... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta SuperSoft Grafts >or= 6mm Intended for use in arterial vascular reco... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Flixene IFG with Assisted Delivery Intended for use in arterial vascular re... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstr... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Flixene Trumpet Grafts >or= 6mm Flixene GW and GWT Grafts >or= 6mm Intended... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta SST Bifurcated Grafts >or= 6mm Intended for use in arterial vascular... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular r... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruct... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Flixene Grafts >or= 6mm Intended for use in arterial vascular reconstruction... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation

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.