Browse Device Recalls

3,664 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,664 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 3,664 FDA device recalls, Class I.

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DateProductReasonClassFirm
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H7490... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), RE... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H74... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H7490... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), RE... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (5PK), REF H74... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), RE... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H7... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H74908... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor ... The failure to detect the partial obstruction in a 2.5mm sensor. Class I SonarMed Inc
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor ... The failure to detect the partial obstruction in a 2.5mm sensor. Class I SonarMed Inc
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 20, 2024 Dr¿ger Perseus A500 Anesthesia Workstation Unexpected shutdown while operating on battery power. Class I Draeger Medical, Inc.
Mar 19, 2024 Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatri... Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... Class I Philips Respironics, Inc.
Mar 19, 2024 Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediat... Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... Class I Philips Respironics, Inc.
Mar 19, 2024 Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ve... Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... Class I Philips Respironics, Inc.
Mar 19, 2024 Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pedia... Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... Class I Philips Respironics, Inc.
Mar 19, 2024 Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric ... Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... Class I Philips Respironics, Inc.
Mar 19, 2024 LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatr... Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... Class I Philips Respironics, Inc.
Mar 19, 2024 Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric... Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... Class I Philips Respironics, Inc.
Mar 15, 2024 Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 9119... Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can co... Class I Elekta Instrument AB
Mar 14, 2024 VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial sus... Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kit... Class I Biomerieux Inc
Mar 13, 2024 BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic mark... Safety Information: Complaints describe complications/adverse events that include pain, infection... Class I Hologic, Inc
Mar 8, 2024 Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, Ster... Their is the potential for distal tip separation at the proximal marker band of the delivery cath... Class I ROUTE 92 MEDICAL INC
Mar 8, 2024 Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for... Their is the potential for distal tip separation at the proximal marker band of the delivery cath... Class I ROUTE 92 MEDICAL INC
Mar 8, 2024 Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. ... Their is the potential for distal tip separation at the proximal marker band of the delivery cath... Class I ROUTE 92 MEDICAL INC
Mar 8, 2024 Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used f... Their is the potential for distal tip separation at the proximal marker band of the delivery cath... Class I ROUTE 92 MEDICAL INC
Mar 8, 2024 Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO.... Their is the potential for distal tip separation at the proximal marker band of the delivery cath... Class I ROUTE 92 MEDICAL INC
Mar 7, 2024 LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy ... Class I Fresenius Kabi USA, LLC
Mar 6, 2024 Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001 Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hou... Class I Outset Medical, Inc.
Mar 5, 2024 t:connect mobile app used in conjunction with t:slim X2 insulin pump with Co... During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iO... Class I Tandem Diabetes Care, 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.