Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

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.

Clear
DateProductReasonClassFirm
May 3, 2024 ADVANTA VXT, 4-7X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 FLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 FLIXENE, 4-6X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 6X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 FLIXENE, 4-6X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 7X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
Nov 1, 2023 Atrium Oasis Drain Single W / AC, Part No. 3600-100 A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expira... Class II Atrium Medical Corporation
Sep 29, 2023 Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036. A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled e... Class II Atrium Medical Corporation
Sep 21, 2023 Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated ... Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment. Class II Atrium Medical Corporation
Sep 18, 2023 Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS ... Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide s... Class II Atrium Medical Corporation
Sep 18, 2023 Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1... Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide s... Class II Atrium Medical Corporation
Sep 18, 2023 Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE;... Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide s... Class II Atrium Medical Corporation
Sep 5, 2023 Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN... Product was re-processed and re-sterilized by a third party using packaging configurations and a ... Class II Atrium Medical Corporation
Sep 5, 2023 Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN... Product was re-processed and re-sterilized by a third party using packaging configurations and a ... Class II Atrium Medical Corporation
Mar 1, 2023 Atrium Pneumostat Chest Drain Valve, Part Number 16100 The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry ... Class II Atrium Medical Corporation
Mar 1, 2023 Express Mini 500 Dry Seal Chest Drain, Part Number 16400 The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry ... Class II Atrium Medical Corporation
Oct 18, 2022 Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000 Warehouse experienced temperature excursions in July and August 2021. It was determined that ther... Class II Atrium Medical Corporation
Apr 21, 2022 Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuat... Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the ... Class II Atrium Medical Corporation
Mar 3, 2022 iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 ... Firm has observed increased rate of customer complaints related to separation of the balloon or c... Class I Atrium Medical Corporation
Mar 3, 2022 Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Numb... Firm has observed increased rate of customer complaints related to separation of the balloon or c... Class I Atrium Medical Corporation
Oct 22, 2021 The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection... Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unrea... Class II Atrium Medical Corporation
Aug 26, 2021 Atrium Pneumostat Chest Drain Valve, Part Number 16100 The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after ... Class II Atrium Medical Corporation
Aug 25, 2021 Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Produ... The product package may potentially contain a mismatched graft that does not contain the radial s... Class II Atrium Medical Corporation
Oct 12, 2018 Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128 This recall has been initiated in response to a seal defect found in certain sterile barrier pouc... Class II Atrium Medical Corporation
Nov 22, 2017 ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use ... An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number ... Class II Atrium Medical Corporation
May 25, 2017 Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part... Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received ... Class II Atrium Medical Corporation
Jan 20, 2017 Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010 Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets o... Class II Atrium Medical Corporation
Jan 20, 2017 Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008 Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets o... Class II Atrium Medical Corporation
Dec 23, 2016 Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Referenc... Chest drains manual vent valve located at the top of affected chest drains could potentially not ... Class II Atrium Medical Corporation
Dec 23, 2016 Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 ... Chest drains manual vent valve located at the top of affected chest drains could potentially not ... Class II Atrium Medical Corporation
Dec 23, 2016 Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-1... Chest drains manual vent valve located at the top of affected chest drains could potentially not ... Class II Atrium Medical Corporation
Dec 23, 2016 Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-0... Chest drains manual vent valve located at the top of affected chest drains could potentially not ... Class II Atrium Medical Corporation
Dec 23, 2016 Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Refe... Chest drains manual vent valve located at the top of affected chest drains could potentially not ... Class II Atrium Medical Corporation
Dec 23, 2016 Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-... Chest drains manual vent valve located at the top of affected chest drains could potentially not ... Class II Atrium Medical Corporation
Dec 23, 2016 Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 In... Chest drains manual vent valve located at the top of affected chest drains could potentially not ... Class II Atrium Medical Corporation
Nov 29, 2016 Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis Blood ... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 Atrium Medical 3620-100: Oasis dual chamber drain with in-line connectors (2 ... Outer Packaging is not sterile 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.