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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.