Browse Device Recalls
38,658 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 38,658 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 38,658 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 29, 2025 | WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; in... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; ... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; i... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contai... | VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencin... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jul 29, 2025 | WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intend... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; in... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; i... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit =... | VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencin... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jul 29, 2025 | WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; in... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; in... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; ... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; in... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 28, 2025 | PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724 | Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or dif... | Class II | VANTIVE US HEALTHCARE LLC |
| Jul 28, 2025 | Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model... | Due to a weld breakage between the pin and inserter holder of the Inserter Adapter. | Class II | ORTOMA AB |
| Jul 28, 2025 | TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 9555... | Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit lea... | Class II | VANTIVE US HEALTHCARE LLC |
| Jul 28, 2025 | PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, ... | Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air De... | Class II | VANTIVE US HEALTHCARE LLC |
| Jul 25, 2025 | One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 0694... | Due to incorrect/lack of Unique Device Identifier (UDI) codes. | Class III | Home Health US, Incorporated |
| Jul 25, 2025 | Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Gen... | Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Er... | Class II | Olympus Corporation of the Americas |
| Jul 25, 2025 | Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT,... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 25, 2025 | 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821... | Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or other... | Class II | Merit Medical Systems, Inc. |
| Jul 25, 2025 | Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 25, 2025 | ZAP-X Radiosurgery System, Model: 300150 | If the radiosurgery system triggers a proximity error message during a long gantry move (greater-... | Class II | Zap Surgical Systems |
| Jul 25, 2025 | Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Gen... | Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Er... | Class II | Olympus Corporation of the Americas |
| Jul 24, 2025 | MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan pan... | Due to the likely presence of contamination in well(s). | Class II | Beckman Coulter, Inc. |
| Jul 24, 2025 | ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardiover... | Affected lead models may experience gradually rising LVSI measurements in association with calcif... | Class I | Boston Scientific Corporation |
| Jul 24, 2025 | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO... | Class I | Dexcom, Inc. |
| Jul 24, 2025 | Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: D... | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO... | Class I | Dexcom, Inc. |
| Jul 24, 2025 | Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Softwa... | The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side o... | Class II | THOR Photomedicine Ltd |
| Jul 24, 2025 | Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Numbe... | The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side o... | Class II | THOR Photomedicine Ltd |
| Jul 24, 2025 | Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Sof... | The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side o... | Class II | THOR Photomedicine Ltd |
| Jul 24, 2025 | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO... | Class I | Dexcom, Inc. |
| Jul 24, 2025 | RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lea... | Affected lead models may experience gradually rising LVSI measurements in association with calcif... | Class I | Boston Scientific Corporation |
| Jul 24, 2025 | ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead,... | Affected lead models may experience gradually rising LVSI measurements in association with calcif... | Class I | Boston Scientific Corporation |
| Jul 24, 2025 | Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Cat... | The defect in the thread area will not allow the device to fully engage with an implant or analog... | Class II | Dentsply IH, Inc. |
| Jul 24, 2025 | Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: D... | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO... | Class I | Dexcom, Inc. |
| Jul 24, 2025 | Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catal... | The defect in the thread area will not allow the device to fully engage with an implant or analog... | Class II | Dentsply IH, Inc. |
| Jul 24, 2025 | Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Numbe... | The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side o... | Class II | THOR Photomedicine Ltd |
| Jul 24, 2025 | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO... | Class I | Dexcom, Inc. |
| Jul 23, 2025 | Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: ... | Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product informatio... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 22, 2025 | OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical ... | The potential for unsterilized product within finished product labeled as sterile. | Class II | LUMENIS, LTD. |
| Jul 22, 2025 | LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-0000... | Due to required inspections not being performed on products/units that have gone through servicing. | Class II | Physio-Control, Inc. |
| Jul 22, 2025 | RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X1100... | Due to incorrect software configuration that potentially allows more than two (2) fractions withi... | Class II | Reflexion Medical, Inc. |
| Jul 22, 2025 | LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-00195... | Due to required inspections not being performed on products/units that have gone through servicing. | Class II | Physio-Control, Inc. |
| Jul 22, 2025 | LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434... | Due to required inspections not being performed on products/units that have gone through servicing. | Class II | Physio-Control, Inc. |
| Jul 22, 2025 | Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitr... | Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain p... | Class II | Trinity Biotech USA |
| Jul 21, 2025 | Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Ballo... | Potential for the balloon in the device to not meet burst specifications. | Class II | SUMMA THERAPEUTICS, LLC |
| Jul 21, 2025 | Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Mode... | The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall. | Class II | B.Braun Medical S.A.S. |
| Jul 21, 2025 | Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF:... | Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16")... | Class I | Tandem Diabetes Care, Inc. |
| Jul 21, 2025 | STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 k... | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap... | Class II | Diagnostica Stago, Inc. |
| Jul 21, 2025 | STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Ant... | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap... | Class II | Diagnostica Stago, 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.