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Browse Device Recalls

2,260 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,260 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 2,260 FDA device recalls in 2021.

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DateProductReasonClassFirm
Dec 22, 2021 Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material N... Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60 COVID test kits were offered for sale and distributed to consumers in the United States without m... Class I Empowered Diagnostics LLC
Dec 22, 2021 NIM TRIVANTAGE EMG Endotracheal Tube There is potential for multiple issues due to a manufacturing nonconformity. Class II Medtronic Xomed, Inc.
Dec 22, 2021 DREAMTOME 49-20MM/450CM Material Number: M00584020 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 39-20-260-025 Material Number: M00573080 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 CovClear COVID-19 Rapid Antigen Test, ATG 900-031 COVID test kits were offered for sale and distributed to consumers in the United States without m... Class I Empowered Diagnostics LLC
Dec 22, 2021 HYDRATOME RX 44-30MM/450CM Material Number: M00583070 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 39-30-260-025 Material Number: M00573100 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 44-20-450-035 Material Number: M00573050 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 44-30-450-035 Material Number: M00573070 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 39-30-450-025 Material Number: M00573110 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 44-30-260-035 Material Number: M00573060 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00... Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135... Philips has identified a specific lot of non-conforming material manufactured by one of its suppl... Class I Philips Respironics, Inc.
Dec 22, 2021 HYDRATOME RX 49-30MM/260CM Material Number: M00583010 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Num... Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 DREAMTOME 49-30MM/260CM Material Number: M00584010 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 8mm FlexDex Needle Driver, Product Code FD-335 ND The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon ins... Class II FlexDex Inc.
Dec 22, 2021 HYDRATOME RX 44-20MM/260CM Material Number: M00583040 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 ... Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 Destino Twist 14F (also branded as Guidestar 14F) There is potential for separation between the threaded hub and threaded cap at the proximal end o... Class II Oscor Inc.
Dec 22, 2021 JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 DREAMTOME 44-30MM/450CM Material Number: M00584070 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 49-20-260-035 Material Number: M00573000 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 DREAMTOME 49-30MM/450CM Material Number: M00584030 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 DREAMTOME 49-20MM/260CM Material Number: M00584000 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL The External Retention Bolster contained in the kit may be a larger diameter than the tube. Class II Avanos Medical, Inc.
Dec 22, 2021 JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 39-20-450-025 Material Number: M00573090 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 39-30-260-025 Material Number: M00573100 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 Universal Chuck-The Universal Chuck is an Instrument Handle provided as an al... Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manu... Class II Synthes (USA) Products LLC
Dec 22, 2021 DREAMTOME 44-30MM/260CM Material Number: M00584050 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 HYDRATOME RX 49-20MM/260CM Material Number: M00583000 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code A... Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the devi... Class II Covidien, LP
Dec 22, 2021 JAGTOME RX 44-20-260-035 Material Number: M00573040 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 F... The External Retention Bolster contained in the kit may be a larger diameter than the tube. Class II Avanos Medical, Inc.
Dec 22, 2021 Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The ... Philips has identified a specific lot of non-conforming material manufactured by one of its suppl... Class I Philips Respironics, Inc.
Dec 22, 2021 HYDRATOME RX 44-20MM/450CM Material Number: M00583060 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 21, 2021 Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110 There is a potential for the outer Tyvek lid to de-bond from the sealed package. Class II Howmedica Osteonics Corp.
Dec 21, 2021 C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, hepar... ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are pos... Class II DRG International, Inc.
Dec 21, 2021 Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endur... Stent Graft Systems built with specific batches of taper tip assemblies have the potential for th... Class II Medtronic Vascular, Inc.
Dec 21, 2021 32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032 There is a potential for the outer Tyvek lid to de-bond from the sealed package. Class II Howmedica Osteonics Corp.
Dec 20, 2021 Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, ... Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible ... Class II Canon Medical System, USA, INC.
Dec 20, 2021 API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualita... Risk of misidentification or delayed results with the absence of identification due to thermoform... Class II Biomerieux Inc
Dec 20, 2021 bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventila... Potential cessation in ventilation can occur under specific conditions. Class I Vyaire Medical
Dec 17, 2021 NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R Due to 16 complaints related to drivers not engaging in implants. According to the firm's invest... Class II Nobel Biocare Usa Llc
Dec 17, 2021 Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon C... The firm has received six (6) complaint reports from customers indicating difficulty removing the... Class II Covidien Llc
Dec 17, 2021 Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI... One ferrite ring expected to be installed on centrifugal pump system power cable may not be present. Class III LivaNova Deutschland GmbH
Dec 16, 2021 Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40 Due to the inadequate adjusting criteria in installation, the system generator on two Digital Ang... Class II Shimadzu Medical Systems

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.